Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
|ClinicalTrials.gov 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
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Masking:||None (Open Label)|
|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|
- Rate of local/regional control
- Rate of systemic disease control
- Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy
- Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0
- Progression-free survival
- Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616785
|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 email@example.com|
|Study Chair:||Joo-Hang Kim, MD||Yonsei University|