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


Phase 3
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

complete response rate

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Keunchil Park

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

2003-02-016

NCT ID:

NCT01125995

Start Date:

June 2003

Completion Date:

May 2013

Related Keywords:

  • Small Cell Lung Cancer
  • limited disease
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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