Меню
Идёт набор NCT06926543

Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

Фаза III С лечением Invasive Breast Cancer Stage III Breast Cancer Stage IIB Breast Cancer

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: Chemoradiation, Chemoradiation.
Кому может быть актуально
Состояния в реестре: Invasive Breast Cancer, Stage III Breast Cancer, Stage IIB Breast Cancer. Базовые параметры: от 18 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)

Обзор

This clinical research aims to determine if concurrent chemotherapy and radiation therapy is more effective than sequential chemotherapy and radiation therapy for patients with stage IIB-III breast cancer. It seeks to answer the following key questions: 1. When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival? 2. What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)? 3. What are each treatment approach's financial costs? Researchers will compare the following to groups: Arm A: Participants in the sequential treatment group will first undergo chemotherapy and then radiation. and Arm B: Participants in the concurrent treatment group will undergo radiation therapy while undergoing chemotherapy. Participants are going to: 1. Get the usual chemotherapy (taxanes and/or anthracyclines). 2. Receive radiation therapy for three to four weeks. 3. Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.

Вмешательства

  • Препарат Chemoradiation
    This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner
  • Препарат Chemoradiation
    This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.

Первичные конечные точки

  • Study the 3-year Disease Free Survival. [Срок оценки: From enrollment to 3 years after treatment at six months intervals.]
Вторичные конечные точки (6)
  • Impact of concurrent regimen on patient's Quality of life using the EORTC QLQ 30 and BR 23 and EQ5D5L questionnaire. [Срок оценки: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.]
  • Subjective and objective assessment of cosmesis in breast-conserving surgery patients, utilizing the Harvard scale and the BCCT core photographic evaluation, respectively. [Срок оценки: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.]
  • The difference in direct and indirect cost of treatment in the two arms will be assessed using the FACT-COST. [Срок оценки: From enrollment at start of adjuvant chemotherapy, pre-radiotherapy and at post radiotherapy treatment.]
  • To assess the rate of lymphedema in the two arms of the trial using subjective and objective methods [Срок оценки: From enrollment at pre-radiotherapy, post-radiotherapy completion and annually thereafter till 3 years]
  • Overall survival (OS)outcome assessment in the two arms. [Срок оценки: From enrollment to 5 years after treatment at 6 months intervals]
  • Breast Cancer Specific Survival (BCSS) will be assessed with regular follow-ups. [Срок оценки: From enrollment to 5 years after treatment at 6 months intervals]

Критерии участия

Критерии включения

  • Pathologically confirmed invasive breast cancer
  • Stage IIB-III invasive breast cancer (AJCC 8th edition)
  • Patients planned for adjuvant chemotherapy and adjuvant radiotherapy
  • Patients fit to receive adjuvant chemotherapy and radiotherapy
  • Age > 18 years

Критерии исключения

  • Hypersensitivity to taxanes
  • Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting)
  • Unable or unwilling for regular follow up
  • Bilateral tumour needed RT to both sides
  • Patients planned for RT to oligometastatic sites
  • Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs (Exceeding the protocol specific mandatory dose constraints).
  • Pregnant patient

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
Открытое
Основная цель
Лечение

Центры проведения

Индия · 5 центров
  • Homi Bhabha Cancer Hospital & Research Centre — Vishkhapatnam
  • Tata Memorial Centre — Mumbai
  • Homi Bhabha Cancer Hospital and Research Centre — New Chandigarh
  • Homi Bhabha Cancer Hospital, Sangrur — Sangrur
  • Mahamana Pandit Madan Mohan Malviya Cancer Centre — Varanasi

Публикации

  • Wadasadawala T, Anup A, Carlton J, Sarin R, Gupta S, Parmar V, Pathak R, Ghosh J, Bajpai J, Gulia S, Krishnamurthy R. CONcurrent ChEmotherapy and RadioTherapy in adjuvant treatment of breast cancer (CONCERT): a phase 2 study. Ecancermedicalscience. 2023 Feb 23;17:1510. doi: 10.3332/ecancer.2023.1510. eCollection 2023. PMID 37113709

Идентификаторы

NCT: NCT06926543 · 4131 · CTRI/2023/06/054280

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗