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

Small Cell Lung Cancer Limited Stage Clinical Trial

— CTV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04543890
• Other study ID #: IRB-2018-129
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2018
• Est. completion date: June 1, 2025

Study information

• Verified date: September 2020
• Source: Zhejiang Cancer Hospital
• Contact: Ming Chen, MD, PhD
• Phone: +86-571-88122199
• Email: chenming[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Small Cell Lung Cancer Limited Stage
• Small Cell Lung Carcinoma

Intervention

Radiation:
• Hyperfractionated radiotherapy
Thoracic radiotherapy (45 Gy/30 fractions) for the Hyperfractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).
• 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.
• Cisplatin
Cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	Chinese PLA General Hospital, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	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.	2 years
Secondary	Overall survival	OS, measured from the date of randomization to the date of death from any cause.	5 years