Editing University Hospital for Tumours of Zagreb Trials

’‘’NCTID’’‘: NCT00117572

’‘’Title’’‘: Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)

’‘’Study Summary’’‘: The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.

’‘’Sponsor’’‘: University of Chicago

’‘’Intervention’’‘: docetaxel

’‘’Start Date’’‘: 2004-11

’‘’Last Updated’’‘: 2018-04-09

’‘’Number of Patients’’‘: 285

’‘’Recruitment Status’’‘: COMPLETED

’‘’Condition’’‘: Cancer of the Pharynx

’‘’NCTID’’‘: NCT00083304

’‘’Title’’‘: Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer

’‘’Study Summary’’’: RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy.

RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better.

This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.

’‘’Sponsor’’‘: Spectrum Pharmaceuticals, Inc

’‘’Intervention’’‘: Efaproxiral

’‘’Start Date’’‘: 2004-02

’‘’Last Updated’’‘: 2013-05-10

’‘’Number of Patients’’‘: 368

’‘’Recruitment Status’’‘: COMPLETED

’‘’Condition’’‘: Breast Cancer

’‘’NCTID’’‘: NCT00388726

’‘’Title’’‘: E7389 Versus Treatment of Physician’s Choice in Patients With Locally Recurrent or Metastatic Breast Cancer

’‘’Study Summary’’‘: The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician’s Choice (TPC) in patients with locally recurrent or metastatic breast cancer.

’‘’Sponsor’’‘: Eisai Inc.

’‘’Intervention’’‘: E7389

’‘’Start Date’’‘: 2006-11

’‘’Last Updated’’‘: 2020-01-07

’‘’Number of Patients’’‘: 762

’‘’Recruitment Status’’‘: COMPLETED

’‘’Condition’’‘: Breast Cancer

’‘’NCTID’’‘: NCT00479752

’‘’Title’’‘: Safety and Efficacy of Folfox4 + Weekly Cetuximab vs Folfox 4+Biweekly Cetuximab by Metastatic Colorectal Cancer

’‘’Study Summary’’‘: To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.

’‘’Sponsor’’‘: Central European Cooperative Oncology Group

’‘’Intervention’’‘: FOLFOX4 (Oxaliplatin), Cetuximab

’‘’Start Date’’‘: 2008-01

’‘’Last Updated’’‘: 2016-02-18

’‘’Number of Patients’’‘: 151

’‘’Recruitment Status’’‘: COMPLETED

’‘’Condition’’’: Colorectal Cancer