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Completed

NCT Number: NCT01125995

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

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medican Center, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

early CCRT

Radiation
  • 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

Radiation
  • 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).

Primary outcomes

  1. complete response rate

    Time frame: 6 months

Secondary outcomes

  1. overall survival

    Time frame: 36 months

  2. objective response rate

    Time frame: 6 months

  3. Progression-free survival

    Time frame: 36 months

  4. toxicity by NCI common toxicity version 2.0

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2011
Study completion
2013
First posted
May 19, 2010
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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