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

Обзор

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.

Подробное описание

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.

Вмешательства

• Лучевая терапия 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.
• Препарат 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.
• Лучевая терапия Vaginal brachytherapy
  Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.

Первичные конечные точки

• 3-year cumulative incidence of grade ≥2 gastrointestinal or genitourinary toxicity [Срок оценки: Median follow up of 3 years]

Вторичные конечные точки (7)

• Pelvic Control Rate at 3 years [Срок оценки: Median follow up of 3 years]
• Disease Free Survival at 3 years [Срок оценки: Median follow up of 3 years]
• Overall Survival at 3 years [Срок оценки: Median follow up of 3 years]
• Acute Toxicities Evaluation [Срок оценки: 3 months]
• Assessment of Quality of Life for cervical cancer patients [Срок оценки: Median follow up of 3 years]
• Assessment of Quality of Life for endometrial cancer patients [Срок оценки: Median follow up of 3 years]
• C-MOSES scoring [Срок оценки: Median follow up of 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индия · 2 центра

• Advanced Centre for Treatment Research and Education in Cancer (ACTREC) — Navi Mumbai
• Tata Memorial Hospital — Mumbai

Идентификаторы

NCT: NCT05857631 · 3910 · CTRI/2023/02/050123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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