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

NCT01125995 | Completed Phase 3

• 1 other identifier: 2003-02-016
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Small Cell Lung Cancer

Keywords

limited disease

Outcome Measures

Primary Outcomes (1)

• complete response rate

  6 months

Secondary Outcomes (4)

• overall survival

  36 months

• objective response rate

  6 months

• Progression-free survival

  36 months

• toxicity by NCI common toxicity version 2.0

  36 months

Study Arms (2)

late CCRT

ACTIVE COMPARATOR

radiotherapy start on day one of the third cycle of chemotherapy

Radiation: late CCRT

Early CCRT

EXPERIMENTAL

Radiotherapy start on day 1 of 1st cycle of chemotherapy

Radiation: early CCRT

Interventions

early CCRT RADIATION

1. patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 \& Cisplatin 70mg/m2 D1. 2. radiotherapy start from day 1 of 1st chemotherapy cycle and complete 5250cGy/25fraction (daily one fraction, 210cGy).

Early CCRT

late CCRT RADIATION

1. patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 \& Cisplatin 70mg/m2 D1. 2. radiotherapy start from day 1 of the third cycle of EP chemotherapy and complete 5250cGy/25fraction (daily one fraction, 210cGy).

late CCRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed small-cell lung cancer
• limited disease status
• with evaluable disease
• 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

You may not qualify if:

• Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
• Patients with active infection requiring antibiotics
• Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
• 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
• previous history of chemotherapy or radiotherapy

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Keunchil Park

Seoul, 135-710, South Korea

Location

Asan Medican Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Keunchil Park

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: June 1, 2003
• Primary Completion: July 1, 2011
• Study Completion: May 1, 2013
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

KR (2)