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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04543890

Acronym

CTV

Enrollment

300

Registered

2020-09-10

Start date

2018-05-01

Completion date

2025-06-01

Last updated

2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer Limited Stage

Keywords

radiotherapy, chemotherapy, radiation dose, radiotherapy target volume

Brief 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.

Interventions

RADIATIONHyperfractionated radiotherapy

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

RADIATIONHypofractionated radiotherapy

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

DRUGEtoposide

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

DRUGCisplatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Histologically/cytologically confirmed diagnosis of SCLC. 2. Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage. 3. Patients should be between 18 and 75 years old. 4. ECOG performance status of 0-1 (Karnofsky performance status ≥ 80). 5. With adequate cardiac, pulmonary, bone marrow, hepatic and renal function. 6. With weight loss no more than 10% within 6 months before diagnosis. 7. Informed consent must be signed.

Exclusion criteria

1. Histology confirmed the mixed NSCLC components; 2. Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.); 3. Any disease or condition contraindicated by radiotherapy or chemotherapy; 4. Malignant pleural effusion and pericardial effusion; 5. Pregnant and lactating women; 6. The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival	2 years	PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause.

Secondary

Measure	Time frame	Description
Overall survival	5 years	OS, measured from the date of randomization to the date of death from any cause.

Countries

China

Contacts

Primary ContactMing Chen, MD, PhD

chenming@zjcc.org.cn+86-571-88122199

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026