Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: NACT: Two cycles of NACT (carboplatin + paclitaxel)
3 weekly 2 cycles
Control Intervention1: CTRT and Brachytherapy: Concurrent chemoradiation with weekly cisplatin followed by brachytherapy
Sponsors
Dr. Partha Sarathi Bhattacharyya
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including BT 2. Biopsy proven cervix cancer (squamous, adenocarcinoma, and adeno-squamous histology) within the age group of 18 to 70 years. 3. Radiologically confirmed stage IIIC1 and IIIC2 (according to FIGO and TNM staging guidelines) 4. Eastern Cooperative oncology Group (ECOG) performance status 5. Adequate organ reserve 6. Willingness to include in the trial (informed consent form).
Exclusion criteria
Exclusion criteria: 1. Patients with any other FIGO stage than IIIC1 and IIIC2 2. Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix 3. A proven history of previous malignancies / radiation 5. NYHA class III heart failure 6. CTCAE v5.0 Grade =2 peripheral neuropathy 7. Baseline hearing loss 8. HIV or Hepatitis B or Hepatitis C infection 9. Mental illness 10. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survivalTimepoint: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acute & late toxicities of chemotherapy and radiotherapy. 2. Overall Survival 3. Effect of NACT in the subgroups like local stage of IIIB/IIIA versus IIB/IIA/IB Timepoint: 24 months | — |
Countries
India
Contacts
Public ContactDr KGK Deepak
Mahatma Gandhi Cancer Hospital and Research Institute
Outcome results
None listed