Trial Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant RT in Head & Neck Malignancies
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Standard conventionally fractionated PORT, hypo-fractionated PORT.
- Кому может быть актуально
- Состояния в реестре: Squamous Cell Carcinoma Head and Neck Cancer (HNSCC). Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Индия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The HYPCON 3 Trial A Phase II/III Randomized Study Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant Radiation Therapy in Head and Neck Malignancies
Обзор
Hypo-fractionated radiotherapy reduces the OTT (overall treatment time) which may in turn reduce rapid accelerated repopulation of clonogenic cells during waiting period after surgery. If this holds true, there is a potential to achieve better loco-regional control in with PORT for HNSCC. There is a strong radiobiological and economic rationale for delivery hypo-fractionated radiotherapy in HNSCC. The HYPCON III trial will be aimed to reduce the number of fractions by 50% (30 fr to 15 fr)
Подробное описание
The current standard radiotherapy regimen for squamous cell carcinomas of the head and neck in the post operative setting is 60-66Gy in 30-33# delivered in 6 weeks with 5 fractions delivered per week. The aim of this study is to test whether a resource sparing, 3weeks, 15 fraction course of hypo-fractionated radiotherapy is non inferior to the conventional fractionation regimen delivering 30 fractions over6 weeks of post operative radiotherapy (PORT). Hypofractionation is already the standard of care in the treatment of cancers like breast cancer which has evolved from 50 Gy in 25 # to 40 Gy in 15# and finally to 26Gy in 5 # with similar tumor control rates and toxicity profiles.
Hypofractionation has shown promising results in prostate, lung cancer and CNS tumors. Hypofractionation has been initially explored in palliative setting for HNSCC. Unlike 2 dimensional RT deliver, recent past has seen a rapid evolution of RT delivery techniques like 3-dimensional conformal radiotherapy (3D CRT), intensity modulated radiotherapy (IMRT), image guided radiotherapy (IGRT), volumetric arc therapy (VMAT). It is now possible to spare adjoining critical organs at risk which make delivery of hypo-fractionated feasible for HNSCC. Recently, the IAEA multicentric trial in radical setting for HNSCC has proved equivalent results in term of both disease control and toxicity with delivery of hypo-fractionated RT. Shorter treatment time is more convenient to the patient. The reduction in the number of fractions required per patient will help in optimal unitization of radiotherapy resources, especially in a low/moderate income country like India where the burden of cancer hugely surpasses the resource availability. Hypo-fractionated schedules have potential to provide attractive cost benefits.
Вмешательства
- Лучевая терапия Standard conventionally fractionated PORT
60Gy in 30 fractions over 6 weeks (5 fractions per week) - Лучевая терапия hypo-fractionated PORT
4Gy in 15 fractions over 3 weeks (5 fractions per week)
Первичные конечные точки
- loco-regional control at 24 months [Срок оценки: 24 months]
Вторичные конечные точки (8)
- swallowing function [Срок оценки: 2 years]
- Disease free survival [Срок оценки: 2 years]
- Overall survival [Срок оценки: 2 years]
- Quality of life EORTC QLQ C30 [Срок оценки: 2 years]
- Quality of life H&N 35 [Срок оценки: 2 years]
- RTOG Acute Toxicity Post Radiation therapy [Срок оценки: 90 days]
- RTOG Late toxicity post radiation therapy [Срок оценки: 2 years]
- Late Toxicity using LENT- SOMA scale [Срок оценки: 12 months]
Критерии участия
Критерии включения
- Patients with pT1-4 squamous cell carcinoma of oral cavity/ oropharynx/ larynx/ hypopharynx with any of the intermediate risk features:
- Positive lymph node (s)
- Perineural invasion
- Lympho-vascular invasion
- Close margins
- Age 18-80yrs
- ECOG performance status 0-1at time of surgery
- Informed consent
- Available FOR long term follow-up
Критерии исключения
- High risk factors following resection: positive-margin(s)and/or extra nodal extension (ENE)
- pT1-2disease and no high-risk features (LVSI, PNI, Close margins,pN0)
- Patients receiving Neo-adjuvant or concurrent Chemotherapy
- Non-Squamous Histology
- Distant metastasis
- Synchronous or second primary malignancy outside of the oropharynx, oral cavity, larynx and hypopharynx
- Pregnant females or nursing mothers due to the probability of congenital anomalies and potential of this regimen to harm nursing infants.
- Prior Radiotherapy to head and neck region
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Индия · 1 центр
- Dr. Aman Sharma, Associate Professor, Radiation Oncology, NCI, AIIMS — Jhajjar
Идентификаторы
NCT: NCT07573956 · AIIMSHYPCON03 · I-1921