Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
| Tracking Information | |||||
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| First Received Date ICMJE | September 24, 2009 | ||||
| Last Updated Date | October 1, 2012 | ||||
| Start Date ICMJE | October 1993 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Patient Outcomes Following Surgery and Accelerated Radiation Therapy/Chemotherapy [ Time Frame: One month after completion of chemotherapy ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To find if surgery followed by radiotherapy and chemotherapy started at the beginning of radiotherapy will give better controls at the primary location and/or distant metastatic site. [ Time Frame: One month after completion of chemotherapy. ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00984997 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors | ||||
| Official Title ICMJE | Phase II Study of Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors | ||||
| Brief Summary |
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| Detailed Description | Eligible (surgically resectable and medically operable) patients will have surgery followed by radiation therapy, given twice daily, for 5 weeks if margins are negative and for 5-1/2 weeks for positive margins. Grossly positive margins can be treated by brachytherapy followed by external radiotherapy. Concomitant chemotherapy consisting of cisplatin given intravenously on days 1 and 8, and etoposide taken by mouth 30-60 minutes prior to each radiotherapy treatment x the first 10 days. The cycle will be repeated start day 29. If the patients are considered to have no evidence of disease in one month after completion of chemotherapy, optional prophylactic radiotherapy to the brain will be give in 10 fractions once daily for 2 weeks. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE |
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| Study Arm (s) | Experimental: Surgery + Radiotherapy + Chemotherapy
Surgery followed by radiotherapy and chemotherapy started at the beginning of radiotherapy. Segmentectomy or lobectomy with en bloc resection of the involved chest. Radiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week. Cisplatin 50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29. Etoposide given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29. Prophylactic Cranial Irradiation 25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional. Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 47 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00984997 | ||||
| Other Study ID Numbers ICMJE | ID92-038 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | October 2012 | ||||
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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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