HYPOfractionated RadioTherapy in Cervical Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorAll India Institute of Medical Sciences

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

396 Participants
are divided into 2 treatment groups
Group A: Standard Fractionated ChemoradiationActive comparator 1 intervention
Group B: Hypofractionated ChemoradiationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

loco-regional control

Loco-regional pelvic control at the end of 3 months

Time frame
3 months

Secondary outcomes

1

Acute toxicity

Acute toxicity, assessed during treatment and follow-up at 3 months

Time frame
3 months
2

Late toxicity

Late toxicity: During follow-up after completion of the treatment at 24 months

Time frame
24 months
3

Disease-free survival

Disease-free survival : Up to 24 months per patient

Time frame
24 months
4

Overall survival

Overall survival: Up to 24 months per patient.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

All India Institute of Medical Sciences

Lead sponsor

Varian, a Siemens Healthineers Company

Collaborator