Trials (Institut Paoli-Calmettes) - Revision history

Francine at 18:40, 14 December 2025

2025-12-14T18:40:05Z

← Older revision		Revision as of 18:40, 14 December 2025
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	<span style="display:none">francecountry</span>		<span style="display:none">francecountry</span>
	Go back to [[Institut Paoli-Calmettes]] page		Go back to [[Institut Paoli-Calmettes]] page

			=== Trials: How to participate ===
			'''Contact information:''' [https://www.institutpaolicalmettes.fr/essais-cliniques/ Click here to access].


	'''NCTID''': NCT04070443		'''NCTID''': NCT04070443
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	<span style="display:none">hasCancerType::D37-D48: Growths of uncertain nature</span>		<span style="display:none">hasCancerType::D37-D48: Growths of uncertain nature</span>
	<span style="display:none">hasCancerType::unknown</span>		<span style="display:none">hasCancerType::unknown</span>
			<span style="display:none">isTrial</span>

Lucas: Update categories.

2025-12-06T12:41:22Z

Update categories.

← Older revision		Revision as of 12:41, 6 December 2025
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	<span style="display:none">hasTrialTitle::Aflibercept and Chemotherapy as First Line Treatment for Metastatic Colorectal Cancer Assessable With DCE-US (PULSAR)</span>		<span style="display:none">hasTrialTitle::Aflibercept and Chemotherapy as First Line Treatment for Metastatic Colorectal Cancer Assessable With DCE-US (PULSAR)</span>
	<span style="display:none">hasTrialTitle::Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer</span>		<span style="display:none">hasTrialTitle::Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer</span>
			<span style="display:none">hasCancerType::C00-D48: All neoplasms</span>
			<span style="display:none">hasCancerType::C00-C97: All cancer types</span>
			<span style="display:none">hasCancerType::C00-C14: Mouth/throat cancers</span>
			<span style="display:none">hasCancerType::C15-C26: Digestive system cancers</span>
			<span style="display:none">hasCancerType::C30-C39: Lung/chest cancers</span>
			<span style="display:none">hasCancerType::C40-C41: Bone cancers</span>
			<span style="display:none">hasCancerType::C43-C44: Skin cancers/melanoma</span>
			<span style="display:none">hasCancerType::C45-C49: Soft tissue cancer</span>
			<span style="display:none">hasCancerType::C50: Breast cancer</span>
			<span style="display:none">hasCancerType::C51-C58: Female genitalia cancers</span>
			<span style="display:none">hasCancerType::C60-C63: Male genitalia cancer</span>
			<span style="display:none">hasCancerType::C64-C68: Urinary system cancers</span>
			<span style="display:none">hasCancerType::C69-C72: Eye and brain cancer</span>
			<span style="display:none">hasCancerType::C73-C75: Thyroid and other gland cancers</span>
			<span style="display:none">hasCancerType::C76-C80: Cancers of unknown or unspecified areas</span>
			<span style="display:none">hasCancerType::C81-C96: Cancers of the blood and immune system</span>
			<span style="display:none">hasCancerType::C97-C97: Cancers in multiple locations from the start</span>
			<span style="display:none">hasCancerType::D00-D09: Early-stage cancers not yet spread</span>
			<span style="display:none">hasCancerType::D10-D36: Benign tumour</span>
			<span style="display:none">hasCancerType::D37-D48: Growths of uncertain nature</span>
			<span style="display:none">hasCancerType::unknown</span>

Francine at 20:47, 2 December 2025

2025-12-02T20:47:53Z

← Older revision		Revision as of 20:47, 2 December 2025
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	<span style="display:none">forproviders</span>		<span style="display:none">forproviders</span>
	<span style="display:none">forresearchers</span>		<span style="display:none">forresearchers</span>
			<span style="display:none">francecountry</span>
	Go back to [[Institut Paoli-Calmettes]] page		Go back to [[Institut Paoli-Calmettes]] page

Lucas: Update categories.

2025-12-02T13:59:09Z

Update categories.

Show changes

Francine at 18:02, 4 January 2024

2024-01-04T18:02:48Z

← Older revision		Revision as of 18:02, 4 January 2024
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	'''NCTID''': NCT01976182		'''NCTID''': NCT01976182
	'''Title''': [[hasTrialTitle::Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia]]		'''Title''': [[hasTrialTitle::Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia]]
	'''Study Summary''': LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It is an indolent disease, the main hematological or autoimmune complications lead to a treatment in more than 60% of patients. Investigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. If first and second line treatments are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are mainly used in the first line. Invetigators just have in the literature data on about 100 patients treated with either of these drugs. Combining the results of our series with those in the literature, invetigators estimate the respective overall response rate (RG) and complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for cyclophosphamide. Thus, there are four objective in this study : # to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from T		'''Study Summary''': LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It is an indolent disease, the main hematological or autoimmune complications lead to a treatment in more than 60% of patients. Investigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. If first and second line treatments are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are mainly used in the first line. Invetigators just have in the literature data on about 100 patients treated with either of these drugs. Combining the results of our series with those in the literature, invetigators estimate the respective overall response rate (RG) and complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for cyclophosphamide. Thus, there are four objective in this study : to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from T K LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease # to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious # to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy # to evaluate the response rate according to the phenotypic subtype of LGL leukemia.
	K LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease # to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious # to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy # to evaluate the response rate according to the phenotypic subtype of LGL leukemia.
	'''Sponsor''': Rennes University Hospital		'''Sponsor''': Rennes University Hospital
	'''Intervention''': Methotrexate		'''Intervention''': Methotrexate

Francine at 18:01, 4 January 2024

2024-01-04T18:01:50Z

← Older revision		Revision as of 18:01, 4 January 2024
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	'''Condition''': Indolent Non-Hodgkin’s Lymphomas		'''Condition''': Indolent Non-Hodgkin’s Lymphomas
	'''NCTID''': NCT03123393		'''NCTID''': NCT03123393
	'''Title''': TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)		'''Title''': [[hasTrialTitle::TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)]]
	'''Study Summary''': The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL.		'''Study Summary''': The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL.
	'''Sponsor''': Calithera Biosciences, Inc		'''Sponsor''': Calithera Biosciences, Inc

Francine at 18:00, 4 January 2024

2024-01-04T18:00:27Z

← Older revision		Revision as of 18:00, 4 January 2024
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	'''NCTID''': NCT01563133		'''NCTID''': NCT01563133
	'''Title''': [[hasTrialTitle::Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas]]		'''Title''': [[hasTrialTitle::Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas]]
	'''Study Summary''': This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses. On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses and Lymph nodes are less developed. The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes. ~~<ol style="list-style-type: decimal;"> <li><p>~~Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by: Ruling out malignancy for patients with benign appearing nCLE images.Characterizing more malignant tumors in the pancreas. Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.		'''Study Summary''': This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses. On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses and Lymph nodes are less developed. The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes. Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by: Ruling out malignancy for patients with benign appearing nCLE images. Characterizing more malignant tumors in the pancreas. Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.
	'''Sponsor''': Mauna Kea Technologies		'''Sponsor''': Mauna Kea Technologies
	'''Intervention''': EUS-FNA		'''Intervention''': EUS-FNA
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	'''NCTID''': NCT02562443		'''NCTID''': NCT02562443
	'''Title''': [[hasTrialTitle::Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients After Failure of an HMA]]		'''Title''': [[hasTrialTitle::Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients After Failure of an HMA]]
	'''Study Summary''': The study’s primary objective ~~<math display="block">~~in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)~~</math>~~, is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.		'''Study Summary''': The study’s primary objective in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC), is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.
	'''Sponsor''': Onconova Therapeutics, Inc.		'''Sponsor''': Onconova Therapeutics, Inc.
	'''Intervention''': rigosertib		'''Intervention''': rigosertib
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	'''Condition''': Myelodysplastic Syndrome		'''Condition''': Myelodysplastic Syndrome
	'''NCTID''': NCT00003652		'''NCTID''': NCT00003652
	'''Title''': [[hasTrialTitle::Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer		'''Title''': [[hasTrialTitle::Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer]]
	'''Study Summary''': RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die]]. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.~~</p></li></ol>~~ PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer.		'''Study Summary''': RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer.
	'''Sponsor''': UNICANCER		'''Sponsor''': UNICANCER
	'''Intervention''': cisplatin		'''Intervention''': cisplatin

Francine at 17:56, 4 January 2024

2024-01-04T17:56:31Z

← Older revision		Revision as of 17:56, 4 January 2024
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	'''NCTID''': NCT01563133		'''NCTID''': NCT01563133
	'''Title''': [[hasTrialTitle::Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas]]		'''Title''': [[hasTrialTitle::Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas]]
	'''Study Summary''': This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses. On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses and Lymph nodes are less developed. The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes. <ol style="list-style-type: decimal;"> <li><p>Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making.~~</p> <p>~~For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by :~~</p> <ul> <li>~~Ruling out malignancy for patients with benign appearing nCLE images.~~</li> <li>~~Characterizing more malignant tumors in the pancreas.~~</li></ul> </li> <li><p>~~Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.		'''Study Summary''': This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses. On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses and Lymph nodes are less developed. The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes. <ol style="list-style-type: decimal;"> <li><p>Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by: Ruling out malignancy for patients with benign appearing nCLE images.Characterizing more malignant tumors in the pancreas. Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.
	'''Sponsor''': Mauna Kea Technologies		'''Sponsor''': Mauna Kea Technologies
	'''Intervention''': EUS-FNA		'''Intervention''': EUS-FNA

Francine at 17:54, 4 January 2024

2024-01-04T17:54:07Z

← Older revision		Revision as of 17:54, 4 January 2024
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	'''Condition''': Colorectal Neoplasms		'''Condition''': Colorectal Neoplasms
	'''NCTID''': NCT00112554		'''NCTID''': NCT00112554
	'''Title''': [[hasTrialTitle::Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia]		'''Title''': [[hasTrialTitle::Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia]]
	'''Study Summary''': RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia.		'''Study Summary''': RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia.
	'''Sponsor''': Vion Pharmaceuticals		'''Sponsor''': Vion Pharmaceuticals

Francine at 17:50, 4 January 2024

2024-01-04T17:50:25Z

← Older revision		Revision as of 17:50, 4 January 2024
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	'''NCTID''': NCT00283985		'''NCTID''': NCT00283985
	'''Title''': [[hasTrialTitle::Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma]]		'''Title''': [[hasTrialTitle::Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma]]
	'''Study Summary''': Nasal		'''Study Summary''': Nasal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin’s lymphoma (NHL) more frequent in Asia than in western countries. When localised, radiotherapy seems to be the best treatment. When radiotherapy cannot be used because of dissemination or relapse, chemotherapy protocols used for other types of NHL give poor results and survival is poor. Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours by l-asparaginase was shown on tumour cell lines and samples. The investigators propose a phase II protocol for patients with refractory or relapsing nasal type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate and dexamethasone. Biological studies will be conducted trying to find factors which could predict responses to this chemotherapy. Since january 2009, the study concerns all patients with nasal type NK-T-cell lymphoma who have not received asparaginase before.
	~~asal~~ type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin’s lymphoma (NHL) more frequent in Asia than in western countries. When localised, radiotherapy seems to be the best treatment. When radiotherapy cannot be used because of dissemination or relapse, chemotherapy protocols used for other types of NHL give poor results and survival is poor. Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours by l-asparaginase was shown on tumour cell lines and samples. The investigators propose a phase II protocol for patients with refractory or relapsing nasal
	~~asal~~ type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate and dexamethasone. Biological studies will be conducted trying to find factors which could predict responses to this chemotherapy. Since january 2009, the study concerns all patients with nasal
	~~asal~~ type NK-T-cell lymphoma who have not received asparaginase before.
	'''Sponsor''': University Hospital, Limoges		'''Sponsor''': University Hospital, Limoges
	'''Intervention''': Kidrolase		'''Intervention''': Kidrolase