A phase II study of additional chemotherapy (neoadjuvant) followed by standard chemoradiation for locally advanced cervical carcinoma
Phase 2
Completed
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecifiedHealth Condition 2: null- Squamous cell carcinoma of cervix, FIGO Stage IB2 to IVA.
- Registration Number
- CTRI/2012/07/002758
- Lead Sponsor
- Dr BR Ambedkar Institute Rotary Cancer Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Female patients of age between 18 and 70 years and performance status ECOG 0-2 .
Squamous cell carcinoma and adenocarcinoma of cervix with histologically confirmed FIGO Stage IB2-IVA and bidimensionally measurable lesion.
Exclusion Criteria
Undifferentiated, neuroendocrine, small cell carcinoma or rare histologies/ Prior chemotherapy or local therapy/ Significant co-morbid conditions or abnormal haematological or biochemical parameters precluding chemotherapy/ Pregnancy and lactation/ Mental illness/
Previous or concomitant malignancies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate (Complete response + partial response)<br>Timepoint: 12 weeks after completion of whole course of treatment
- Secondary Outcome Measures
Name Time Method Progression free survivalTimepoint: 1 year after treatment;Response rate ( Complete remission + partial remission)Timepoint: At the end of 6 weeks of Paclitaxel and Carboplatin;To determine the toxicity in the two arms.<br>Timepoint: Weekly during treatment. <br>Every 3 months after treatment.