A Phase III Trial to Investigate the Effect of NACT in Lymph Node Positive Cervix Cancer

Phase 3

• Conditions: Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

• Registration Number: CTRI/2023/08/056902
• Lead Sponsor: Dr. Partha Sarathi Bhattacharyya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survivalTimepoint: 24 months

Secondary Outcome Measures

Name	Time	Method
1. Acute & late toxicities of chemotherapy and radiotherapy. <br/ ><br>2. Overall Survival <br/ ><br>3. Effect of NACT in the subgroups like local stage of IIIB/IIIA versus IIB/IIA/IB <br/ ><br>Timepoint: 24 months