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

May 29, 2013 updated by: Keunchil Park, Samsung Medical Center

A Randomized Phase III Trial for Timing of Radiation in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Keunchil Park
      • Seoul, Korea, Republic of
        • Asan Medican Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete response rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 36 months
36 months
Progression-free survival
Time Frame: 36 months
36 months
objective response rate
Time Frame: 6 months
6 months
toxicity by NCI common toxicity version 2.0
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (ESTIMATE)

May 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-02-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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