ow dose immunotherapy with Chemotherapy prior to Standard treatment of chemotherapy plus radiation in advanced Carcinoma Cervix
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
- Registration Number
- CTRI/2024/07/071051
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 Histologically confirmed FIGO stage IIIC-IVa squamous, adeno or adenosquamous carcinoma of the cervix
2 Deemed suitable and fit for radical chemoradiation.
3 Medically fit to receive carboplatin and paclitaxel.
4 ECOG performance status 0 – 1
5 Aged 18 and over
1 Presence of locally advanced disease who is not fit for radical chemoradiation
2 Participants with more than or equal to Grade 2 peripheral neuropathy
3 Participants with an active, known or suspected autoimmune disease
4 Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of enrollment
5 Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 To determine the overall response rate to neoadjuvant chemoimmunotherapy according to RECIST 1.1.Timepoint: 12 weeks after completion of all treatment.
- Secondary Outcome Measures
Name Time Method 1 To assess response rates 12 weeks after completing all treatment <br/ ><br>2 Patterns of first relapse <br/ ><br>3 To determine the Progression Free survival and overall survival. <br/ ><br>4 To determine adverse events according to CTCAEv5.0. <br/ ><br>5 To assess the Quality of Life <br/ ><br>Timepoint: 12 weeks after completing all treatment