Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histopathology-confirmed FIGO 2018 stage IB2-IVA squamous, adenosquamous or adenocarcinoma of the cervix. 2. Medically fit to receive carboplatin and paclitaxel. 3. ECOG performance status 0 2 4. Aged 18 and over 5. Adequate renal function (defined as a GFR 60 ml per min or more using the Wright equation), liver function, and hematological profile.
Exclusion criteria
Exclusion criteria: 1. Previous pelvic radiotherapy. 2. Recurrent or metastatic disease at diagnosis. 3. Pregnancy or lactation. 4. Other synchronous malignancy. 5. Hydronephrosis, unless relieved by stenting or nephrostomy. 6. Patients who did not consent.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the progression-free survival (PFS). 2. To evaluate the best response. 3. To assess feasibility: proportion of treatment completion, treatment delays, and discontinuation. 4. To evaluate the toxicity profile (CTCAE v5.0). Timepoint: At baseline, 3 months and 6 months | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate the objective response rate (ORR) (by RECIST v1.1)Timepoint: At baseline, 3 months and 6 months | — |
Countries
India
Contacts
Institute of Medical sciences and SUM Hospital