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NCT Number: NCT07008716

Omitting CTV for Primary Tumor in LS-SCLC

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.

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Key information

Conditions

SCLC, Limited Stage Disease Attributes Disease Progression Pathologic Processes Pathological Conditions, Signs and Symptoms Progression Radiation Exposure Radiation Injuries Radiotherapy Side Effect Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

radiation therapy

Radiation

Twice-daily (45 Gy/30 fractions) or once-daily (45 Gy/15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy

Etoposide + carboplatin; Etoposide + cisplatin

Drug

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.

Creating CTV for primary tumor

Radiation

A margin of 0.8 cm beyond the gross target volume of primary tumor.

prophylactic cranial irradiation (PCI)

Radiation

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).

Primary outcomes

  1. Local progression free survival

    Time frame: 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

  2. Severe toxicity free survival

    Time frame: From the date chemotherapy commenced to the first record of serious adverse events related to radiotherapy, to be assessed up to 3 years

Secondary outcomes

  1. Overall survival

    Time frame: From the date chemotherapy commenced to the date of death from any cause or the end of follow-up at 3 years

  2. Progression free survival

    Time frame: From the date chemotherapy commenced to disease progression or death, whichever occurs first, to be assessed up to 3 years

  3. Number of participants with recurrence or metastasis as evaluated by RECIST 1.1

    Time frame: From the date chemotherapy commenced to the end of follow-up at 3 years

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: From the date chemotherapy commenced to the end of follow-up at 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Chen

CONTACT

[email protected]

86+02087343504

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2032
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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