Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

Официальное название

Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

Обзор

The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.

Подробное описание

The purpose of this trial is to test a deescalated 3-fraction SBRT regimen to 45 Gy in 3 fractions for centrally located thoracic tumors in a phase II trial. This will provide prospectively collected data on the safety and efficacy of a three-fraction regimen in the previously defined "No Fly Zone" for both primary non-small cell lung cancer (NSCLC) and for lung metastases of any histology. This registration describes the design and eligibility criteria for the 36 NSCLC subjects the investigators plan to enroll. Local control, cancer-specific survival, and overall survival results from the NSCLC patients will be compared to both 3- and 5-fraction historical controls, specifically RTOG 0236 and 0813 results.

The outcomes of the metastatic patients will also be reported.

There will also be a quality-of-life component to the study to assess the impact of a shorter overall treatment time and the clinical impact of radiation side effects.

Вмешательства

• Лучевая терапия 45 Gray (Gy) regimen
  Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.

Первичные конечные точки

• Safety of the stereotactic body radiotherapy regimen (SBRT) [Срок оценки: From administration of SBRT up to 2 years post-SBRT]
• local control (LC) of 3-fraction stereotactic body radiotherapy [Срок оценки: Up to 10 years post-enrollment.]

Вторичные конечные точки (5)

• lobar control [Срок оценки: Up to 10 years post-enrollment.]
• regional control [Срок оценки: Up to 10 years post-enrollment.]
• distant control [Срок оценки: Up to 10 years post-enrollment.]
• overall survival [Срок оценки: Up to 10 years post-enrollment.]
• progression-free survival [Срок оценки: Up to 10 years post-enrollment.]

Критерии участия

Критерии включения

• Lung tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal bronchial tree (trachea, carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or within 2 cm of (whether abutting or not) major vessels, esophagus, or heart (based on RTOG and MD Anderson Cancer Center definitions 33,34). Multiple concurrent isocenters are allowed if at least one tumor meets the above criteria, and if all dose constraints for the plan summation can be met. These concurrent tumors other than study target lesion can be treated as per SOC and does not necessarily have to meet the above size limit. The PI will review and prospectively approve any lesions abutting these organs.
• ECOG Performance Status of 0-2
• Age > 18
• Patients must sign a study-specific consent form.

Критерии исключения

• Prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as OAR structures receiving the following doses (in <3Gy per fraction):

• Spinal cord previously irradiated to > 40 Gy
• Brachial plexus previously irradiated to > 50 Gy
• Small intestine, large intestine, or stomach previously irradiated to > 45Gy
• Brainstem previously irradiated to > 50 Gy
• Lung previously irradiated with prior V20Gy > 35%
• Active systemic, pulmonary, or pericardial infection
• Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
• Pregnant or lactating
• Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation

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

США · 6 центров

• Smilow Cancer Hospital Care Center at Greenwich — Greenwich
• Smilow Cancer Hospital Care Center - Guilford — Guilford
• Smilow Cancer Hospital - Hamden Care Center — Hamden
• Smilow Cancer Hospital — New Haven
• Smilow Cancer Hospital Care Center - Trumbull — Trumbull
• Smilow Cancer Hospital Care Center - Waterford — Waterford

Идентификаторы

NCT: NCT04210492 · 2000025868

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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