NCT04543890

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

A Multicenter, Prospective, Randomized Study Comparing Hypofractionated Radiotherapy With Hyperfractionated Radiotherapy Combined With Concurrent Chemotherapy and Omitting Clinical Target Volumes of the Primary Tumor in Limited-stage SCLC

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-05-01
• Primary completion: 2023-06-01
• Completion: 2025-06-01
• First posted: 2020-09-10
• Last updated: 2020-09-10

Locations

1 site across 1 country: China