HYPOfractionated RadioTherapy in Cervical Cancer

NCT07625943 | Recruiting DMC

• 2 other identifiers: N-2707CTRI/2026/01/101615
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective, randomized, non-inferiority clinical trial which will test whether a short course of radiation treatment (hypofractionation) for cervical cancer works as well as the standard longer course. Cervical cancer is one of the most common cancers in women in India, and many patients have trouble completing treatment because it takes several weeks and requires many hospital visits. In this trial, females with locally advanced cervical cancer will be randomly assigned to one of two treatment groups. One group will receive the standard radiation schedule with External Beam RadioTherapy (EBRT) over about 5 weeks, weekly cisplatin chemotherapy, and brachytherapy. The other group will receive a shorter, hypofractionated external beam radiotherapy schedule over about 3 weeks, the same chemotherapy, and brachytherapy. Researchers will compare the two groups to see whether the hypofractionated schedule is non-inferior to the standard radiation therapy schedule. The main outcomes will be tumor control in the pelvis, side effects, survival, and quality of life. If the hypofractionated schedule meets the non-inferiority limit, it could reduce treatment time, improve patient convenience, and help more people receive treatment in busy cancer centers in emerging countries.

Conditions

Cervical Cancer Squamous Cell; Cervical Cancer

Keywords

cervical cancer; chemoradiation; hypofractionation; brachytherapy; external beam radiotherapy

Outcome Measures

Primary Outcomes (1)

• loco-regional control

  Loco-regional pelvic control at the end of 3 months

  3 months

Secondary Outcomes (5)

• Acute toxicity

  3 months

• Late toxicity

  24 months

• Disease-free survival

  24 months

• Overall survival

  24 months

• Quality of Life Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

  24 months

Study Arms (2)

Standard Fractionated Chemoradiation

ACTIVE COMPARATOR

Standard fractionated chemoradiation consisting of external beam radiotherapy to 45 Gy in 25 fractions delivered in conventional daily fractions over 5 weeks, concurrent weekly cisplatin, and brachytherapy to 700 cGy in 4 fractions.

Radiation: Standard fractionated chemoradiation

Hypofractionated Chemoradiation

EXPERIMENTAL

Hypofractionated chemoradiation consisting of external beam radiotherapy to 37.5 Gy in 15 fractions over approximately 3 weeks, concurrent weekly cisplatin, and brachytherapy to 700 cGy in 4 fractions.

Radiation: Hypofractionated Chemoradiation

Interventions

Hypofractionated Chemoradiation RADIATION

Hypofractionated chemoradiation consisting of external beam radiotherapy to 37.5 Gy in 15 fractions over approximately 3 weeks, concurrent weekly cisplatin, and brachytherapy to 700 cGy in 4 fractions.

Hypofractionated Chemoradiation

Standard fractionated chemoradiation RADIATION

Standard fractionated chemoradiation consisting of external beam radiotherapy to 45 Gy in 25 fractions delivered in conventional daily fractions over 5 weeks, concurrent weekly cisplatin, and brachytherapy to 700 cGy in 4 fractions.

Standard Fractionated Chemoradiation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Females are eligible to participate: Cervical Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged 18 to 65 years.
• Histopathologically confirmed cervical cancer.
• FIGO stage IB3 to IIIC1.
• Suitable for definitive concurrent chemoradiation.
• ECOG performance status 0 to 2.
• Adequate hematological, renal, and hepatic function.
• Able and willing to provide informed consent.

You may not qualify if:

• ECOG performance status 3 or higher.
• FIGO stage IIIC2, IVA, or IVB.
• Prior pelvic radiotherapy or prior chemotherapy for cervical cancer.
• Inflammatory bowel disease.
• Hydronephrosis.
• Pregnancy.
• Synchronous malignancy.
• Any serious medical condition that would interfere with protocol treatment or follow-up.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Varian, a Siemens Healthineers Company: collaborator

Study Sites (1)

National Cancer Institute, All India Institute of Medical Sciences, New Delhi, India

New Delhi, New Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Karun Kamboj, MD - Radiation Oncology

CONTACT

9416613389; karunkamboj04@aiims.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label, because both treatment schedules are visibly different and masking is not practical.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized in a 1:1 ratio to receive either standard fractionated chemoradiation with brachytherapy or hypofractionated chemoradiation with brachytherapy. The study is open-label and designed as a non-inferiority treatment trial.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 4, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): January 30, 2030
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)