Status:
UNKNOWN
Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Cancer of Cervix
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
Carcinoma cervix is a common malignancy in women in developing countries including India. The standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant chemoradiation (...
Detailed Description
Cancer of the uterine cervix is a major health problem in the developing countries including India and is the commonest cancer amongst women in India with nearly 1,00000 new women diagnosed to have th...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Women with histologically proven invasive squamous cell carcinoma of the uterine cervix, stages IB2-IIB.
- Age 18-65 years (both inclusive)
- No evidence of visceral, skeletal or extra-abdominal nodal metastases.
- No history of prior or present second malignancy
- Good performance status (Karnofsky performance score \> 70 or ECOG PS \<2)
- Normal hematological \& biochemical parameters including normal renal function.
- Presence of associated co-morbid conditions that preclude participation in the study.
- No prior treatment.
- Informed consent for participation in the study.
Exclusion
Key Trial Info
Start Date :
September 4 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
635 Patients enrolled
Trial Details
Trial ID
NCT00193739
Start Date
September 4 2003
End Date
July 31 2020
Last Update
September 20 2019
Active Locations (1)
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1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012