A Study Where twice weekly radiotherapy will be given internally during external beam radiotherapy treatment to see the feasibility toxicity and efficacy in locally advanced cervical cancer

A prospective study to see the feasibility toxicity and efficacy of twice weekly interdigited intracavitary brachytherapy in patients of carcinoma cervix stage II B Undergoing concurrent chemoradiation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021486

Enrollment

Registered

2019-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: C538- Malignant neoplasm of overlappingsites of cervix uteri

Interventions

Intervention1: TWICE WEEKLY INTERDIGITATED INTRACAVITARY BRACHYTHERAPY IN PATIENTS OF CARCINOMA CERVIX STAGE II B UNDERGOING CONCURRENT CHEMORADIATION: Treatment will be started with concurrent chemor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age: 18 to 65 years. 2) Histology proven squamous cell carcinoma of cervix. 3) Patients with stage IIB 4) ECOG performance status 0 to 2 5) No previous history of treatment of cancer. 6) Creatinine clearance more than or equal to 60 ml/min 7) Patients must sign a study specific informed consent prior to study entry.

Exclusion criteria

Exclusion criteria: 1) Evidence of distant metastases by clinical or radiological examination. 2) Previous history of treatment of pelvic malignancies. 3) Previous history of pelvic irradiation. 4) Other primary malignancy. 5) Significant co-morbidities that would not allow or would require modification of treatment of the study protocol.

Design outcomes

Primary

Measure	Time frame
Primary endpoint: To assess the acute toxicity according to the Radiation Therapy Oncology Group [RTOG] criteria. To assess the response rate in terms of complete response, partial response, stable disease and progressive disease (RECIST criteria, version 1.1) after 6 weeks from the completion of treatment. Timepoint: 3 months	—

Secondary

Measure	Time frame
Secondary endpoints: a)To assess the disease free survival (DFS) and time to progression (TTP) after treatment in patients having CR. Timepoint: 3 months	—

Countries

India

Contacts

Public ContactLEKSHMI R SHENOI

Sskm And Ipgmer

pritam.ks1990@gmail.com9591640742

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026