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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 6, 2000 | ||||
| Last Updated Date | July 23, 2009 | ||||
| Start Date ICMJE | March 2001 | ||||
| Primary Completion Date | December 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006470 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vaccine Therapy Plus Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer That Has Been Completely Removed in Surgery | ||||
| Official Title ICMJE | Phase II Study of Postoperative Adjuvant Immunotherapy and Radiation in Patients With Completely Resected Stage II and Stage IIIA Non-Small Cell Lung Cancer | ||||
| Brief Summary | RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these two treatments may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with radiation therapy in treating patients who have stage II or stage IIIA non-small cell lung cancer that has been completely removed in surgery. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients receive monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody 3H1 anti-idiotype vaccine intracutaneously in separate sites once weekly for 3 weeks beginning 2-7 weeks (no later than 49 days) after surgery and then subcutaneously once monthly for 2 years regardless of disease progression. Beginning no more than 1 week after the third postoperative vaccination, all patients undergo radiotherapy 5 days a week for 5-6 weeks. Patients with extracapsular nodal metastases or T3 lesions also undergo 6 additional radiotherapy boosts. Patients are followed at 4-6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | December 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006470 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068293, RTOG-9909 | ||||
| Study Sponsor ICMJE | Radiation Therapy Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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