Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
NCT ID: NCT05857631
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-05-29
2029-05-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hypofractionated Image guided External Beam Radiation
Adjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer.
Hypofractionated 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.
Cisplatin
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
Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.
Interventions
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Hypofractionated 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.
Cisplatin
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
Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
80 Years
FEMALE
No
Sponsors
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Tata Memorial Centre
OTHER
Responsible Party
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Prachi Mittal, MD, Radiation Oncology
Assistant Professor
Principal Investigators
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Dr. Prachi D Mittal, MD
Role: PRINCIPAL_INVESTIGATOR
Tata Memorial Hospital
Locations
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Advanced Centre for Treatment Research and Education in Cancer (ACTREC)
Navi Mumbai, Maharahstra, India
Tata Memorial Hospital
Mumbai, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTRI/2023/02/050123
Identifier Type: REGISTRY
Identifier Source: secondary_id
3910
Identifier Type: -
Identifier Source: org_study_id
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