Status:
COMPLETED
CRP on Radiobiological and Clinical Studies on Viral-Induced Cancer's Response to Radiotherapy
Lead Sponsor:
International Atomic Energy Agency
Conditions:
Cervix Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT00122772
Start Date
November 1 2005
End Date
June 1 2010
Last Update
October 14 2011
Active Locations (11)
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1
University of Vienna; Department of Radiotherapy and Radiobiology
Vienna, Austria
2
rmandade de Santa Casa de Misericordia de Porto Alegre; Hospital Santa Rita
Porto Alegre, Brazil
3
Peel Regional Cancer Centre
Mississauga, Ontario, Canada
4
Department of Atomic Energy (DAE); Tata Memorial Centre (TMC); Tata
Mumbai, India