NCT00122772

CRP on Radiobiological and Clinical Studies on Viral-Induced Cancer's Response to Radiotherapy

CRP on Radiobiological and Clinical Studies on Viral-induced Cancer's Response to Radiotherapy With Comprehensive Morbidity Assessment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: International Atomic Energy Agency · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to study clinical effects of two/four high dose rate (HDR) brachytherapy applications and teletherapy with or without weekly cisplatin in cervix cancer.

Detailed description

This study uses 2x2 design to test external beam radiotherapy (46 Gy in 23 daily fractions) with and without HDR brachytherapy (2 fractions of 9 Gy versus 4 fractions of 7 Gy) with and without weekly Cisplatin (40 mg/sqm) The overall objective was to test the clinical outcome and toxicity of a resource-sparing schedule of radiotherapy with or without chemotherapy treatment for cervix cancer, to detect molecular markers that will predict tumor control/resistance and to establish whether E6 and E7 viral proteins predict cellular radiosensitivity in oxic and hypoxic conditions in vitro and tumor control/resistance in vivo. A new component of the CRP was added, for which the objective is to optimize the data capture, provide more details of normal tissue outcomes following cancer treatments in developing countries and validate this approach using patients participating in the ongoing CRP. This will be achieved by exploring data capture using the questionnaire template on a computer in face-to-face interviews ("active" data collection) and comparing it with standard data collection obtained from the clinical notes ("passive" data collection) during the still ongoing CRP E3.30.24. The method of data collection will be chosen at random for each case stratified by centre. The reason for using an ongoing CRP is that it will test the usefulness of the new method and validate it in a multicentre study. During the performance of the new CRP, the same institutions as for E3.30.24 will be engaged.

Conditions

• Cervix Cancer

Interventions

Type	Name	Description
RADIATION	Radiotherapy	External Beam Radiation 46Gy in 23 daily fractions High Dose Brachytherapy 2 fractions of 9Gy
RADIATION	Radiotherapy	External Beam Radiotherapy 46Gy in 23 daily fractions High Dose Brachytherapy 4 fractions of 7Gy
RADIATION	Radiotherapy/Cisplatin	External Beam Radiation 46Gy in 23 daily fractions High Dose Brachytherapy 2 fractions of 9Gy Cisplatin 40 mg/sqm weekly
RADIATION	Radiotherapy/Cisplatin	External Beam Radiotherapy 46Gy in 23 daily fractions High Dose Brachytherapy 4 fractions of 7Gy Cisplatin 40mg/sqm weekly

Timeline

• Start date: 2005-11-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2005-07-22
• Last updated: 2011-10-14

Locations

11 sites across 11 countries: Austria, Brazil, Canada, India, Morocco, North Macedonia, Pakistan, Peru, South Africa, South Korea, United Kingdom