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Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study

ConditionsCervical CancerEndometrial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorTata Memorial Centre

About this trial

The primary aim of the trial is to investigate the late effects of hypofractionated external radiation (39 Gy in 13 fractions) in patients requiring post-operative radiation for early-stage cervical and endometrial cancers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Histologically confirmed diagnosis of cervical cancer post hysterectomy with intermediate or high-risk features, requiring adjuvant EBRT ± concurrent chemotherapy OR histologically confirmed diagnosis of endometrial cancer post hysterectomy requiring adjuvant (chemo)radiotherapy to pelvis with/without vaginal brachytherapy.

Disqualifiers

Patients with macroscopic residual disease (R+ resection) postoperatively

Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)

Patients treated with chemotherapy for any prior malignancy at any time

Patients treated with pelvic radiation previously

Trial design

Design model

Single group

Treatments tested in this trial

  • Hypofractionated Image guided External Beam Radiation Therapy (EBRT)

    Radiation

    External beam radiotherapy to pelvis: Post operative hypofractionated external beam radiotherapy with intensity modulated/arc technique, to a dose of 39 Gy in 13 fractions, at 3 Gy per fraction, delivered once daily, 5 days a week, over 2.5-3 weeks.

  • Cisplatin

    Drug

    Patients who require adjuvant chemotherapy along with radiation, based on predefined risk features, will receive 5 cycles of cisplatin on a weekly basis with a dose of 40 mg/m2 by IV infusion over a period of 1 hour 2-4 hours prior to start of EBRT.

  • Vaginal brachytherapy

    Radiation

    Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Hypofractionated Image guided External Beam RadiationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

3-year cumulative incidence of grade ≥2 gastrointestinal or genitourinary toxicity

To evaluate the 3-year cumulative incidence of late grade ≥2 gastrointestinal or genitourinary toxicity using CTCAE version 5 scoring receiving radiation with hypo fractionation.

Time frame
Median follow up of 3 years

Secondary outcomes

1

Pelvic Control Rate at 3 years

To report 3 year pelvic control rate (local and pelvic nodal) in patients receiving hypofractionated radiotherapy.

Time frame
Median follow up of 3 years
2

Disease Free Survival at 3 years

To report 3 year disease free survival in patients receiving hypo fractionated radiotherapy.

Time frame
Median follow up of 3 years
3

Overall Survival at 3 years

To report 3 year overall survival in patients receiving hypo fractionated radiotherapy.

Time frame
Median follow up of 3 years
4

Acute Toxicities Evaluation

Acute toxicity will be reported using CTCAE V. 5.0

Time frame
3 months

Other outcomes

Sponsors and contacts

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

Tata Memorial Centre

Lead sponsor

Source ClinicalTrials.gov
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