CRP on Radiobiological and Clinical Studies on Viral-Induced Cancer's Response to Radiotherapy
- Conditions
- Cervix Cancer
- Interventions
- Radiation: RadiotherapyRadiation: Radiotherapy/Cisplatin
- Registration Number
- NCT00122772
- Lead Sponsor
- International Atomic Energy Agency
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 601
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EBR plus 2 HDBT fractions Radiotherapy External Beam Radiotherapy High Dose Brachytherapy (2 fractions of 9Gy) EBR plus 4 fractions HDBT Radiotherapy External Beam Radiotherapy High Dose Brachytherapy (4 fractions of 7Gy) EBR/2 HDBT fractions/Chemotherapy Radiotherapy/Cisplatin External Beam Radiation High Dose Brachytherapy (2 fractions of 9Gy) Cisplatin EBR/4 fractions HDBT/chemotherapy Radiotherapy/Cisplatin External Beam Radiation High Dose Brachytherapy (4 fractions of 7Gy) Cisplatin
- Primary Outcome Measures
Name Time Method Clinical Outcome 5 years Treatment Toxicity 3 months Molecular markers that will predict tumor control/resistance 5 years Whether E6 and E7 viral proteins predict cellular radiosensitivity in oxic and hypoxic conditions in vitro and tumor control/resistance in vivo 5 years Effectiveness of a questionnaire template on a computer in face-to-face interviews in a multicentre multinational study. 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Department of Atomic Energy (DAE); Tata Memorial Centre (TMC); Tata
🇮🇳Mumbai, India
Institut National d'Oncologie
🇲🇦Rabat, Morocco
Bahawalpur Institute of Nuclear Medicine and Oncology (BINO)
🇵🇰Bahawalpur, Pakistan
National Cancer Center
🇰🇷Seoul, Korea, Republic of
Instituto Nacional de Enfermedades Neoplásicas
🇵🇪Lima, Peru
Christie Hospital; NHS Trust
🇬🇧Manchester, United Kingdom
rmandade de Santa Casa de Misericordia de Porto Alegre; Hospital Santa Rita
🇧🇷Porto Alegre, Brazil
University of Vienna; Department of Radiotherapy and Radiobiology
🇦🇹Vienna, Austria
Peel Regional Cancer Centre
🇨🇦Mississauga, Ontario, Canada
Radiotherapy and Oncology University Clinic
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of
Department of Radiation Oncology, Groote Schuur Hospital
🇿🇦Cape Town, South Africa