Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified Health Condition 2: null- Squamous cell carcinoma of cervix, FIGO Stage IB2 to IVA.
Conditions
Interventions
Intervention1: Weekly Paclitaxel and Carboplatin followed by concurrent Cisplatin and Radiotherapy: Paclitaxel(60mg/m2) over 1 hour on day 1,weekly for 6 weeks (weeks 1-6)/Carboplatin (AUC 2)over 1 ho
Sponsors
Dr BR Ambedkar Institute Rotary Cancer Hospital
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (Complete response + partial response) Timepoint: 12 weeks after completion of whole course of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: Weekly during treatment. Every 3 months after treatment. | — |
Countries
India
Contacts
Public ContactDr Lalit kumar
AIIMS
Outcome results
None listed