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Hypofraction Radiotherapy for Limited-Stage Small Cell Lung Cancer

NCT05523908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-21

No results posted yet for this study

Summary

Concurrent chemoradiotherapy is the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos. Conventional fractionation of 66Gy/33f and hyperfractionation of 45Gy/30f twice daily have been acknowledged as the two standard radiotherapy modalities according to CONVERT study. In 2021, a phase II trial demonstrated that 60Gy/40f twice daily was superior to the standard 45Gy/30f twice daily in light of overall survival (2y OS 74.2% vs. 39% p=0.0005), which to some extent implied that higher dose may confer better survival. Hypofractionated radiotherapy was another useful modality to increase biological effective dose with the advantage of short course and convenience. The effectiveness and safety of 60Gy/15f has been demonstrated in the treatment of locally advanced non-small cell lung cancer. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy for stage III locally advanced small cell lung cancer.

Conditions

  • Safety Issues
  • Efficacy, Self

Interventions

RADIATION

High-dose hypofraction Arm

Patients in this arm would receive high-dose fractionated radiotherapy with 60Gy/15f

RADIATION

Low-dose hypofraction Arm (Standard BED)

Patients in this arm would receive low-dose fractionated radiotherapy with 48Gy/12f

Sponsors & Collaborators

  • Anhui Provincial Hospital

    lead OTHER_GOV

Principal Investigators

  • Dong P Qian, M.D. · The First Affiliated Hospital of USTC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-08-31
Completion
2024-08-01

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 NCT05523908 on ClinicalTrials.gov