RecruitingNot ApplicableNCT05857631

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

Sponsor

Tata Memorial Centre

Enrollment

90 participants

Start Date

May 29, 2023

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer Endometrial Cancer

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

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.

Exclusion Criteria6

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
Patients with human immunodeficiency virus infection
Any preexisting medical conditions that may interfere with the assessment of genitourinary or gastrointestinal toxicity (This includes patients with irritable bowel syndrome, subacute intestinal obstruction, anal incontinence, hemorrhoids precluding analysis of gastro-intestinal toxicities, urinary incontinence, recurrent urinary tract infections)

Interventions

RADIATIONHypofractionated Image guided External Beam Radiation Therapy (EBRT)

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.

DRUGCisplatin

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.

RADIATIONVaginal brachytherapy

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