Omitting CTV for Primary Tumor in LS-SCLC

Официальное название

Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial

Обзор

This randomized controlled non-inferior trial prospectively enrolled patients with limited-stage small cell lung cancer (LS-SCLC). Patients in the experimental group would receive radiotherapy with omission of the clinical target volume (CTV) for the primary tumor, while those in the control group would receive radiotherapy including CTV. The efficacy and toxicity of the two groups are compared to provide evidence for the radiotherapy of LS-SCLC. The target volume of LS-SCLC may be reduced by omitting CTV without increasing local recurrence but potentially reducing the dose to organs at risk and the side effects.

Вмешательства

• Лучевая терапия Radiation Therapy
  Twice-daily (45 Gy/30 fractions) or once-daily (45 Gy/15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy
• Препарат Etoposide + carboplatin; Etoposide + cisplatin
  Carboplatin IV (AUC=5) on day 1 combined with etoposide IV (100mg/m2) on days 1-3, or cisplatin IV (25mg/m2) on days 1-3 combined with etoposide IV (100mg/m2) on days 1-3. Treatment is repeated every 21 days for 4-6 cycles.
• Лучевая терапия Creating CTV for primary tumor
  A margin of 0.8 cm beyond the gross target volume of primary tumor.
• Лучевая терапия prophylactic cranial irradiation (PCI)
  Beginning 4-6 weeks after chemoradiotherapy completion, patients in both arms who achieve a complete or partial response without brain metastasis receive PCI at 25 Gy/10 fractions or 26 Gy/13 fractions, delivered once daily (5 days per week).

Первичные конечные точки

• Local progression free survival [Срок оценки: From the date chemotherapy commenced to the first clinical or radiological evidence of progressive disease at the primary site or death, whichever occurs first, to be assessed up to 3 years]
• Severe toxicity free survival [Срок оценки: From the date chemotherapy commenced to the first record of serious adverse events related to radiotherapy, to be assessed up to 3 years]

Вторичные конечные точки (4)

• Overall survival [Срок оценки: From the date chemotherapy commenced to the date of death from any cause or the end of follow-up at 3 years]
• Progression free survival [Срок оценки: From the date chemotherapy commenced to disease progression or death, whichever occurs first, to be assessed up to 3 years]
• Number of participants with recurrence or metastasis as evaluated by RECIST 1.1 [Срок оценки: From the date chemotherapy commenced to the end of follow-up at 3 years]
• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: From the date chemotherapy commenced to the end of follow-up at 3 years]

Критерии участия

Критерии включения

• Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis;
• Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months;
• Have measurable lesions per RECIST 1.1 criteria;
• Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin;
• Lung function test: FEV1 ≥ 1 L (Optional);
• Complete blood count: neutrophil count ≥ 1.5 x 10\^9/L, hemoglobin ≥ 100 g/L, platelet count ≥ 100 x 10\^9/L;
• Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN);
• Liver function: AST and ALT ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN;
• Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent.

Критерии исключения

• Other malignant tumors (prior or concurrent), except those that have been curatively treated with disease-free survival ≥ 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary thyroid cancer;
• Uncontrolled heart disease or myocardial infarction within the past 6 months;
• Patients with a history of mental illness;
• Pregnant and lactating patients;
• Poorly controlled diabetes and hypertension;
• Interstitial pneumonia or active pulmonary fibrosis;
• Active infection;
• Other conditions unsuitable for enrollment (per investigator judgment).

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

Китай · 2 центра

• Sun Yat-sen University Cancer Center — Гуанчжоу
• Zhejiang Provincial Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT07008716 · B2022-792

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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