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Omitting CTV for Primary Tumor in LS-SCLC

NCT07008716 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 852

Last updated 2025-06-06

No results posted yet for this study

Summary

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.

Conditions

  • SCLC, Limited Stage
  • Radiation Exposure
  • Radiotherapy Side Effect
  • Progression

Interventions

RADIATION

Radiation Therapy

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

DRUG

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.

RADIATION

Creating CTV for primary tumor

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

RADIATION

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).

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-03
Primary Completion
2027-12-31
Completion
2032-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07008716 on ClinicalTrials.gov