Clinical trial NCT05857631: Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
Official title: Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Endometrial Cancer
Keywords: Hypofractionated Radiation
Radiotherapy, Adjuvant
Radiotherapy, Intensity modulated
Late gastrointestinal and genitourinary toxicities
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, open-label phase II trial investigating the cumulative incidence of late grade ≥2 gastro-intestinal or genito-urinary toxicities in patients receiving adjuvant hypofractionated external beam radiotherapy to the pelvis for post-operative cervical or endometrial cancer.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a phase II prospective study that will be accruing patients with post operative cervical or endometrial cancer requiring adjuvant pelvic radiation.

External beam radiotherapy (Intensity modulated radiotherapy/arc technique) will be delivered to pelvis to a dose of 39 Gray (Gy) in 13 fractions at 3 Gy per fraction, delivered once daily over 2.5 - 3 weeks. Treatment will be delivered with Intensity Modulated Radiotherapy (IMRT) under image guidance. Patients for whom concurrent chemotherapy is indicated (as per adverse risk features) will receive concurrent weekly cisplatin (40mg/m2) based on standard institutional protocol. All patients with post-operative cervical cancer will receive vaginal brachytherapy after the completion of external beam radiation. Patients with endometrial cancer with certain pre defined risk factors will also receive vaginal brachytherapy. The dose of vaginal brachytherapy will be 6 Gy high dose rate brachytherapy delivered as two different fractions, one week apart. Patients will be evaluated by the concerned investigators on a weekly basis during radiation therapy and all the toxicities will be documented according to the CTCAE V 5.0.

Patients will be followed up 3 monthly for the first 2 years, then 6 monthly from years 2 - 5, and annually thereafter. CTCAE version 5 will be used for toxicity grading at each follow-up. Quality of life assessment will be performed at baseline prior to the start of radiation and on follow-up at pre-specified times using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and Cervix - 24 (CX24) for cervical cancer patients and Endometrium 24 (EN24) for endometrial cancer patients.

Eligibility criteria: Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
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 Criteria:

1. Patients with macroscopic residual disease (R+ resection) postoperatively
2. Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)
3. Patients treated with chemotherapy for any prior malignancy at any time
4. Patients treated with pelvic radiation previously
5. Patients with human immunodeficiency virus infection
6. 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)

Primary outcomes:
measure: 3-year cumulative incidence of grade ≥2 gastrointestinal or genitourinary toxicity
timeFrame: Median follow up of 3 years
Secondary outcomes:
measure: Pelvic Control Rate at 3 years
timeFrame: Median follow up of 3 years
measure: Disease Free Survival at 3 years
timeFrame: Median follow up of 3 years
measure: Overall Survival at 3 years
timeFrame: Median follow up of 3 years
measure: Acute Toxicities Evaluation
timeFrame: 3 months
measure: Assessment of Quality of Life for cervical cancer patients
timeFrame: Median follow up of 3 years
measure: Assessment of Quality of Life for endometrial cancer patients
timeFrame: Median follow up of 3 years
measure: C-MOSES scoring
timeFrame: Median follow up of 3 years
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Advanced Centre for Treatment Research and Education in Cancer (ACTREC)
state: Maharahstra
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
Study officials:
affiliation: Tata Memorial Hospital
name: Dr. Prachi D Mittal, MD
role: PRINCIPAL_INVESTIGATOR
References: