CTRI/2023/08/056902
Recruiting
Phase 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 enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
- Sponsor
- Dr. Partha Sarathi Bhattacharyya
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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
Outcomes
Primary Outcomes
Not specified
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