Early Versus Late Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized Phase III Trial for Timing of Radiation in Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125995
• Other study ID #: 2003-02-016
• Status: Completed
• Phase: Phase 3
• First received: May 17, 2010
• Last updated: May 29, 2013
• Start date: June 2003
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy and toxicity of different timing of concurrent chemoradiation in the treatment of limited disease status Small-cell lung cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: May 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically confirmed small-cell lung cancer

• limited disease status

• with evaluable disease

• 18 years or older

• ECOG performance status 0,1,2

• expected survival time should be 12 weeks or longer

• Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin =1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance = 50mL/min

• Written informed consent form

Exclusion Criteria:

1. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia

2. Patients with active infection requiring antibiotics

3. Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)

4. Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

5. previous history of chemotherapy or radiotherapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Radiation:
• early CCRT
patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 & Cisplatin 70mg/m2 D1. radiotherapy start from day 1 of 1st chemotherapy cycle and complete 5250cGy/25fraction (daily one fraction, 210cGy).
• late CCRT
patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 & Cisplatin 70mg/m2 D1. radiotherapy start from day 1 of the third cycle of EP chemotherapy and complete 5250cGy/25fraction (daily one fraction, 210cGy).

Locations

Country	Name	City	State
Korea, Republic of	Asan Medican Center	Seoul
Korea, Republic of	Keunchil Park	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response rate		6 months	Yes
Secondary	overall survival		36 months	Yes
Secondary	objective response rate		6 months	Yes
Secondary	Progression-free survival		36 months	Yes
Secondary	toxicity by NCI common toxicity version 2.0		36 months	Yes