Stereotactic Body Radiotherapy Boost Versus Simultaneous Integrated Boost to Pelvic Nodes Among Patients Receiving Radical Chemoradiation in Carcinoma Cervix

Обзор

Cervical cancer is a significant cause of morbidity and mortality among women worldwide. Radiotherapy, in combination with chemotherapy or as a standalone treatment, is an effective treatment option for cervical cancer. However, traditional radiotherapy has its limitations, such as the potential for damage to surrounding healthy tissues. Stereotactic Body RadioTherapy (SBRT) is a newer radiotherapy technique that delivers high doses of radiation to the tumor with minimal damage to the surrounding tissues. This study aims to evaluate the safety of Stereotactic Body RadioTherapy to involved node in cervical cancer.

Подробное описание

The goal of this observational study is to compare the safety profile of Stereotactic Body Radiotherapy Boost vs Simultaneous Integrated Boost to pelvic nodes among patients with Stage III-C carcinoma cervix by assessing the acute GI and GU toxicity (\>Grade 3 GI/GU toxicity) within 30 days of completion of treatment.

Вмешательства

• Лучевая терапия Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes
  Experimental Arm: Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes Participants in the experimental arm will receive definitive radical chemoradiation for stage IIIC carcinoma cervix with a stereotactic body radiotherapy (SBRT) boost to the radiologically involved pelvic lymph node(s). The purpose of this intervention is to intensify the dose to gross nodal disease while maintaining acceptable doses to nearby organs at risk, including bowel, rectum, bladder, sigmoid, spinal co
• Лучевая терапия Standard Arm: Simultaneous Integrated Boost to involved pelvic node
  Patients in the standard arm will receive radical chemoradiation with pelvic external beam radiotherapy to 45 Gy in 25 fractions over 5 weeks, along with a simultaneous integrated boost to involved pelvic node(s) to a total dose of 55 Gy or 57.5 Gy in 25 fractions, delivered in a simultaneous integrated manner according to nodal size, location, and institutional planning constraints. Concurrent weekly cisplatin 40 mg/m² will be administered during external beam radiotherapy, subject to adequate

Первичные конечные точки

• Incidence of grade 3 or higher treatment-related adverse events [Срок оценки: 30 days]

Вторичные конечные точки (3)

• Grade 3 or higher acute gastrointestinal and genitourinary toxicity [Срок оценки: 6 months]
• Dosimetric comparison [Срок оценки: 6 months]
• Local control [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Patients with stage IIIC cervical cancer
• No previous pelvic radiation therapy or surgery
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Критерии исключения

• Patients with stage I or stage II or stage IV disease.
• Patients with prior malignancies or active autoimmune diseases
• Uncontrolled medical comorbidity

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индия · 3 центра

• All India Institute of Medical Sciences — Delhi
• Karun Kamboj — Delhi
• National Cancer Institute, All India Institute of Medical Sciences, New Delhi, India — New Delhi

Идентификаторы

NCT: NCT07585929 · A-1087

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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