CRP on Radiobiological and Clinical Studies on Viral-Induced Cancer's Response to Radiotherapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervix Cancer |
Radiation: Radiotherapy Radiation: Radiotherapy/Cisplatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CRP on Radiobiological and Clinical Studies on Viral-induced Cancer's Response to Radiotherapy With Comprehensive Morbidity Assessment |
- Clinical Outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Treatment Toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Molecular markers that will predict tumor control/resistance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Whether E6 and E7 viral proteins predict cellular radiosensitivity in oxic and hypoxic conditions in vitro and tumor control/resistance in vivo [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Effectiveness of a questionnaire template on a computer in face-to-face interviews in a multicentre multinational study. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 601 |
| Study Start Date: | November 2005 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EBR plus 2 HDBT fractions
External Beam Radiotherapy High Dose Brachytherapy (2 fractions of 9Gy)
|
Radiation: Radiotherapy
External Beam Radiation 46Gy in 23 daily fractions High Dose Brachytherapy 2 fractions of 9Gy |
|
Active Comparator: EBR plus 4 fractions HDBT
External Beam Radiotherapy High Dose Brachytherapy (4 fractions of 7Gy)
|
Radiation: Radiotherapy
External Beam Radiotherapy 46Gy in 23 daily fractions High Dose Brachytherapy 4 fractions of 7Gy |
|
Experimental: EBR/2 HDBT fractions/Chemotherapy
External Beam Radiation High Dose Brachytherapy (2 fractions of 9Gy) Cisplatin |
Radiation: Radiotherapy/Cisplatin
External Beam Radiation 46Gy in 23 daily fractions High Dose Brachytherapy 2 fractions of 9Gy Cisplatin 40 mg/sqm weekly |
|
Experimental: EBR/4 fractions HDBT/chemotherapy
External Beam Radiation High Dose Brachytherapy (4 fractions of 7Gy) Cisplatin |
Radiation: Radiotherapy/Cisplatin
External Beam Radiotherapy 46Gy in 23 daily fractions High Dose Brachytherapy 4 fractions of 7Gy Cisplatin 40mg/sqm weekly |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
- Histologically confirmed cervix cancer.
- FIGO stage IIB and IIIB
- Age over 18 years
- Karnofsky status >/= 50
- No significant medical contraindications to the administration of full dose chemotherapy.
- Adequate bone marrow function -- Haemoglobin ³ 10 g/dl without or with transfusion, white blood count ³ 4000/mL, platelet count ³ 140,000/mL.
- Adequate renal function: creatinine < 1.2 mg/dL or 120 μmol/l (urinary diversion is permitted). Electrolytes and calcium within normal limits for institution. Liver function tests if clinically indicated. Tests have to be obtained within 30 days before registration.
- Expected good compliance for follow-up.
- Written informed consent for participation in this study.
EXCLUSION CRITERIA:
- Recent malignancy, other than the index cervical carcinoma or non-melanoma cutaneous cancers, diagnosed within 5 years of entry
- Life expectancy <6 months, for any reason other than the index cervical carcinoma
- Any severe medical ailment, continuing pregnancy, or breast feeding, as conditions that interfere in present treatment
- Previous chemotherapy in past 1 year
- Severe psychiatric disorder, making compliance and follow-up difficult.
- Paraaortic nodes (PAN >1 cm), suspicious or positive for metastatic involvement on radiological imaging. (Note: patients with positive pelvic lymph nodes are still eligible for the study, but they cannot have suspicious or positive PAN.)
- Bilateral hydronephrosis
- Prior radiation to the pelvis
Contacts and Locations| Austria | |
| University of Vienna; Department of Radiotherapy and Radiobiology | |
| Vienna, Austria | |
| Brazil | |
| rmandade de Santa Casa de Misericordia de Porto Alegre; Hospital Santa Rita | |
| Porto Alegre, Brazil | |
| Canada, Ontario | |
| Peel Regional Cancer Centre | |
| Mississauga, Ontario, Canada | |
| India | |
| Department of Atomic Energy (DAE); Tata Memorial Centre (TMC); Tata | |
| Mumbai, India | |
| Korea, Republic of | |
| National Cancer Center | |
| Seoul, Korea, Republic of | |
| Macedonia, The Former Yugoslav Republic of | |
| Radiotherapy and Oncology University Clinic | |
| Skopje, Macedonia, The Former Yugoslav Republic of | |
| Morocco | |
| Institut National d'Oncologie | |
| Rabat, Morocco | |
| Pakistan | |
| Bahawalpur Institute of Nuclear Medicine and Oncology (BINO) | |
| Bahawalpur, Pakistan | |
| Peru | |
| Instituto Nacional de Enfermedades Neoplásicas | |
| Lima, Peru | |
| South Africa | |
| Department of Radiation Oncology, Groote Schuur Hospital | |
| Cape Town, South Africa | |
| United Kingdom | |
| Christie Hospital; NHS Trust | |
| Manchester, United Kingdom | |
| Study Director: | Eduardo H. Zubizarreta, M.D. | International Atomic Energy Agency (IAEA) |
More Information
Additional Information:
Publications:
| Responsible Party: | International Atomic Energy Agency |
| ClinicalTrials.gov Identifier: | NCT00122772 History of Changes |
| Other Study ID Numbers: | E33026 |
| Study First Received: | July 19, 2005 |
| Last Updated: | October 13, 2011 |
| Health Authority: | United Nations: International Atomic Energy Agency |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013