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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01125995
First received: May 17, 2010
Last updated: May 16, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
 Radiation: early CCRT
Radiation: late CCRT
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial for Timing of Radiation in Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • complete response rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • objective response rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • toxicity by NCI common toxicity version 2.0 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Enrollment: 222
Study Start Date: June 2003
Estimated Study Completion Date: December 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: late CCRT
radiotherapy start on day one of the third cycle of chemotherapy
 Radiation: late CCRT
  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).
Experimental: Early CCRT
Radiotherapy start on day 1 of 1st cycle of chemotherapy
 Radiation: early CCRT
  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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125995

Locations
Korea, Republic of
Keunchil Park
Seoul, Korea, Republic of, 135-710
Asan Medican Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Keunchil Park Samsung Medical Center
  More Information

No publications provided

Responsible Party: Keunchil Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01125995     History of Changes
Other Study ID Numbers: 2003-02-016
Study First Received: May 17, 2010
Last Updated: May 16, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
limited disease

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013