Clinical trial · Interventional
HYPOfractionated RadioTherapy in Cervical Cancer
Hypofractionated Radiotherapy in Cervical Cancer: A Non-inferiority Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer Squamous Cell | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Chemoradiation | Radiation | — | UNRESOLVED |
| Standard fractionated chemoradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Fractionated Chemoradiation
- description
- 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.
- interventionNames
- Radiation: Standard fractionated chemoradiation
- type
- EXPERIMENTAL
- label
- Hypofractionated Chemoradiation
- description
- 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.
- interventionNames
- Radiation: Hypofractionated Chemoradiation
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: 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.
References
Publications (0)
Data not yet available