Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost

Обзор

This is a monocentric, non-randomized, open-label, superiority phase II clinical investigation evaluating the efficacy of additional Cyberknife irradiation after a doublet of Platinum Salts-based chemotherapy and concomitant radiotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC), with an interim analysis.

Вмешательства

• Лучевая терапия Cyberknife irradiation
  Additional Cyberknife irradiation after a doublet of Platinum Salts-based chemotherapy and concomitant radiotherapy in inoperable patients with locally advanced non-small cell lung carcinoma

Первичные конечные точки

• To evaluate progression-free survival at 24 months after additional Cyberknife irradiation following concomitant radio-chemotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC). [Срок оценки: 24 months]

Вторичные конечные точки (5)

• Evaluate overall survival at 24 months and at 60 months [Срок оценки: 60 months]
• Evaluate specific survival at 24 months and at 60 months [Срок оценки: 60 months]
• Evaluate the efficacy of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months [Срок оценки: 24 months]
• Evaluate overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months [Срок оценки: 24 months]
• Evaluate overall quality of life before Cyberknife, 1 month post-Cyberknife and 6 months post-Cyberknife [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Patients aged 18 years old or more
• ECOG 0 to 2
• Histologically proven non-small cell lung cancer
• Stage III non-metastatic tumor, not allowing for immediate surgery
• Volume(s) on the evaluation chest CT scan done at the end of conventional radiotherapy (between 34 \& 46 Gy) meeting the following criteria:

• 1 to 3 target volumes of less than 5 cm in greatest diameter
• And allowing for the delivery of a CyberKnife boost to be carried out in compliance with the manufacturer requirements and with the doses delivered to the organs at risk (OAR/fractions) defined in appendix 2
• Patients who have received a " Taxcis " treatment consisting in 2 cycles of induction chemotherapy (platinium-based doublet) and then at least 40 Gy of irradiation in combination with at least 2 cycles of concomitant chemotherapy (platinium-based doublet)
• No contraindication to implantable venous devices (IVDs)
• Patient who has read the patient information note and signed the consent form
• If applicable, negative pregnancy test\*
• Eligible for National Health Insurance in France
• Chest CT scan performed prior to Taxcis

Критерии исключения

• Positive EGFR mutation
• Exercise-induced dyspnea associated with heart failure equal to or greater than stage III of the New York Heart Association (NYHA) classification, (appendix 3)
• Coronary syndrome or heart failure in the last three months
• Pulmonary function test contraindicating radiotherapy: PFT-FEV1 inferior to 1 L.
• After radio-chemotherapy, presence of any toxicity contraindicating Cyberknife irradiation
• Vulnerable populations and participants as defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017:

• Incapacitated participants who have not given or refused informed consent prior to the onset of their incapacity, who are not under the provisions of article 64 ;
• Pregnant or breast-feeding women who are not covered by the provisions of article 66 ;
• Adults under legal protection or unable to express their consent.

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

Франция · 1 центр

• Centre Antoine Lacassagne — Nice

Идентификаторы

NCT: NCT06627738 · 2022/17 · 2024-A01394-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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