|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer | ||||
| Official Title † | Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy, such as cisplatin, irinotecan, carboplatin, and etoposide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cisplatin and irinotecan followed by carboplatin, etoposide, and radiation therapy in treating patients who have limited-stage small cell lung cancer. |
||||
| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study.
After the completion of consolidation therapy, patients who achieve a complete remission or very good partial remission may undergo prophylactic radiotherapy to the brain. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 15-24 months. |
||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Efficacy, in terms of survival, at 2 years after initiation of study treatment [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Overall response rate as measured by RECIST at completion of study treatment [ Designated as safety issue: No ] Overall survival [ Designated as safety issue: No ] Failure-free survival [ Designated as safety issue: No ] Response rate as measured by RECIST after completion of 2 courses of induction chemotherapy [ Designated as safety issue: No ] Toxicity as measured by NCI CTCAE v.30 after completion of 2 courses of chemotherapy [ Designated as safety issue: Yes ] Tolerability as measured by chemotherapy dose-delivered dose delays after completion of study treatment [ Designated as safety issue: Yes ] |
||||
| Condition † | Lung Cancer | ||||
| Intervention † | Drug: carboplatin Drug: cisplatin Drug: etoposide Drug: irinotecan hydrochloride Procedure: radiation therapy |
||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | November 2003 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00072527 | ||||
| Organization ID | CDR0000339871 | ||||
| Secondary IDs †† | CALGB-30206 | ||||
| Study Sponsor † | Cancer and Leukemia Group B | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2005 | ||||
| First Received Date † | November 4, 2003 | ||||
| Last Updated Date | July 23, 2008 | ||||