CTRI/2023/08/056902RecruitingPhase 3
Effect of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation and Brachytherapy in Cervix Cancer Stage IIIC1/IIIC2 - a Phase III Prospective Randomized Controlled Trial - ENACT-RT
Dr. Partha Sarathi Bhattacharyya0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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 < 2
- •5. Adequate organ reserve
- •6. Willingness to include in the trial (informed consent form).
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
Investigators
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