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Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616785
Recruitment Status : Unknown
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : February 15, 2008
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: etoposide Drug: irinotecan hydrochloride Radiation: radiation therapy Phase 2

Detailed Description:



  • To evaluate the efficacy of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in patients with locally advanced, unresectable stage III non-small cell lung cancer.
  • To evaluate the feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy after induction chemotherapy in these patients.


  • To evaluate the toxicity of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in these patients.
  • To assess whether this induction chemotherapy regimen will improve patient survival when compared with outcomes from the predecessor study, SWOG-9019.

OUTLINE: Patients receive dose-dense induction chemotherapy comprising irinotecan hydrochloride IV and cisplatin IV on days 1 and 8. Treatment repeats every 21 days for up to 2 courses.

After completion of induction chemotherapy, patients undergo radiotherapy five days a week for approximately 7 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and 29-33.

After completion of study therapy, patients are followed at 6 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Irinotecan and Cisplatin Induction Chemotherapy Followed by Radiotherapy Concurrently With Etoposide/Cisplatin in Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer
Study Start Date : June 2007
Estimated Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. Rate of local/regional control
  2. Rate of systemic disease control
  3. Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy

Secondary Outcome Measures :
  1. Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0
  2. Progression-free survival
  3. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Stage IIIA (N2) or IIIB disease

      • Pathologic documentation of N2-3 mediastinal lymph nodes is encouraged but not required if nodal size is ≥ 1.5 cm in largest diameter
      • No stage IIIB disease with malignant pleural effusion or superior sulcus tumor
  • At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors
  • Unresectable disease
  • No known brain metastasis


  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm³
  • Hemoglobin ≥ 9.0 g/dL (can be corrected by transfusion)
  • Platelet count ≥ 100,000/mm³
  • Creatinine < 1.5 mg/dL
  • Total bilirubin < 2 times upper limit of normal (ULN)
  • Transaminases < 3 times ULN
  • Patient compliance and geographic proximity that allow adequate follow up
  • No serious, uncontrolled systemic intercurrent illness (e.g., infections or poorly controlled diabetes)
  • No history of significant neurological or mental disorder, including seizures or dementia
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No active cardiac disease not controlled by therapy
  • No myocardial infarction within the past 12 months


  • No prior chemotherapy or radiotherapy for NSCLC
  • No other concurrent systemic chemotherapy, investigational drug, or radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00616785

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Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Joo-Hang Kim, MD    +82-10-4507-6063   
Sponsors and Collaborators
Yonsei University
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Study Chair: Joo-Hang Kim, MD Yonsei University

Layout table for additonal information Identifier: NCT00616785     History of Changes
Other Study ID Numbers: CDR0000584442
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: September 2008

Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors