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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | May 6, 2003 | ||||||||||||
| Last Updated Date | August 1, 2009 | ||||||||||||
| Start Date ICMJE | July 2003 | ||||||||||||
| Estimated Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Incidence of local recurrence 2 years after completion of study treatment [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
Incidence of local recurrence 2 years after completion of study treatment | ||||||||||||
| Change History | Complete list of historical versions of study NCT00060333 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma | ||||||||||||
| Official Title ICMJE | Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma | ||||||||||||
| Brief Summary | RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery may kill any tumor cells remaining after surgery. PURPOSE: This phase II trial is studying how well adjuvant radiation therapy works in treating patients who have undergone surgery for desmoplastic melanoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Within 8 weeks after surgical resection, patients undergo radiotherapy twice weekly over 2.5 weeks in the absence of unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 40 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 | Melanoma (Skin) | ||||||||||||
| 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 | Active, not recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||||||
| Completion Date | |||||||||||||
| Estimated Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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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 | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00060333 | ||||||||||||
| Responsible Party | Jan C. Buckner, North Central Cancer Treatment Group | ||||||||||||
| Study ID Numbers ICMJE | CDR0000301633, NCCTG-N0275 | ||||||||||||
| Study Sponsor ICMJE | North Central Cancer Treatment Group | ||||||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||
| Verification Date | July 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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