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A Prospective Study Comparing Two Radiotherapy Dose/Fraction and Omitting CTVs of the Primary Tumor in Limited SCLC

NCT04543890 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-09-10

No results posted yet for this study

Summary

For most of the patients with limited-stage SCLC, thoracic radiotherapy combined with chemotherapy is the standard treatment at present. However, the optimal dose / fraction of thoracic radiotherapy for limited-stage SCLC is still in controversial.This study is designed as a prospecitive randomized non-inferiority trial.

Conditions

  • Small Cell Lung Cancer Limited Stage

Interventions

RADIATION

Hyperfractionated radiotherapy

Thoracic radiotherapy (45 Gy/30 fractions) for the Hyperfractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).

RADIATION

Hypofractionated radiotherapy

Thoracic radiotherapy (45 Gy/15 fractions) for the Hypofractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).

DRUG

Etoposide

Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.

DRUG

Cisplatin

Cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • Guangdong Medical College

    collaborator OTHER

  • Zhejiang Cancer Hospital

    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
2018-05-01
Primary Completion
2023-06-01
Completion
2025-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04543890 on ClinicalTrials.gov