Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri
Conditions
Interventions
Intervention1: CHEMOTHERAPY AND LOW DOSE IMMUNOTHERAPY FOLLOWED BY STANDARD CHEMORADIATION: Neoadjuvant carboplatin AUC 2 IV D1+ paclitaxel 60mg/m2 D1 weekly for 6 weeks in combination with Nivolumab
Sponsors
Christian Medical College, Vellore
Eligibility
Inclusion criteria
Inclusion criteria: A participant will be eligible for inclusion in the study if the participant: 1. Has FIGO 2018 Stage IIB to IIIC1 biopsy-proven cervical cancer of squamous cell, adenocarcinoma, or adenosquamous histology. For patients with Stage IIIC1, the maximum number of involved nodes should be one or two, and each node should measure less than 14 millimeters. In any equivocal case, the decision to screen and enroll shall be based on discussion in the Gynecological Tumor Board. 2. Has not received any prior definitive treatment for cervical cancer, including surgery (except localized cervical procedures), radiation, systemic therapy, or investigational agents. The patient must also be immunotherapy-na ve. 3. Is older than 18 years of age and has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within seven days prior to the first dose of study intervention. 4. Has provided documented informed consent for participation in the study (or through a legally acceptable representative, if applicable). 5. Has adequate organ function as defined below: Hematological function: Absolute neutrophil count (ANC) of at least 1500 per microliter Platelet count of at least 100,000 per microliter Hemoglobin level of at least 8.0 grams per deciliter Renal function: Serum creatinine less than or equal to 1.5 times the institutional upper limit of normal Or, measured or calculated creatinine clearance of at least 50 milliliters per minute for participants with creatinine above 1.5 times the institutional upper limit of normal Hepatic function: Total bilirubin less than or equal to 1.5 times the upper limit of normal Or, direct bilirubin within normal limits for participants with total bilirubin greater than 1.5 times the upper limit of normal Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) less than or equal to 2.5 times the upper limit of normal
Exclusion criteria
Exclusion criteria: 1. Previous hysterectomy 2. Bilateral hydronephrosis 3. Anatomical contraindication for brachytherapy 4. Cisplatin contraindication 5. Immunodeficiency disease diagnosis needing chronic systemic steroids 6. Synchronous active second malignancy 7. Severe hypersensitivity to nivolumab 8. History of or active pneumonitis or interstitial lung disease 9. Psychiatric or substance abuse disorder 10. Active or planned Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival at 5 yearsTimepoint: 3 years and 5 years since randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response ratesTimepoint: 12 weeks from the date of completion of all protocol-related therapy;Event free survivalTimepoint: 3 years and 5 years since randomization;Incidence of adverse eventsTimepoint: During and upto 30 days after all protocol related therapy | — |
Countries
India
Contacts
Public ContactAshish Singh
Christian Medical College, Vellore, India
Outcome results
None listed