About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Hypofractionated Chemoradiation
RadiationHypofractionated 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.
Standard fractionated chemoradiation
RadiationStandard 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.
Treatment groups
Trial outcomes
Primary outcomes
loco-regional control
Loco-regional pelvic control at the end of 3 months
Secondary outcomes
Acute toxicity
Acute toxicity, assessed during treatment and follow-up at 3 months
Late toxicity
Late toxicity: During follow-up after completion of the treatment at 24 months
Disease-free survival
Disease-free survival : Up to 24 months per patient
Overall survival
Overall survival: Up to 24 months per patient.
Sponsors and contacts
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All India Institute of Medical Sciences
Lead sponsor
Varian, a Siemens Healthineers Company
Collaborator