![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00060333 |
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.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Procedure: adjuvant therapy Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma |
Estimated Enrollment: | 40 |
Study Start Date: | July 2003 |
Estimated Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed desmoplastic melanoma
Locally recurrent OR at least 1 mm in depth
Disease resected using standard wide resection or Moh's surgery
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No other malignancy within the past 5 years except for the following diseases:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Barbara A. Pockaj, MD | Mayo Clinic Hospital |
Investigator: | John H. Donohue, MD | Mayo Clinic |
Investigator: | Jan L. Kasperbauer, MD | Mayo Clinic |
Responsible Party: | North Central Cancer Treatment Group ( Jan C. Buckner ) |
Study ID Numbers: | CDR0000301633, NCCTG-N0275 |
Study First Received: | May 6, 2003 |
Last Updated: | April 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00060333 History of Changes |
Health Authority: | Unspecified |
recurrent melanoma stage I melanoma stage II melanoma stage III melanoma |
Neuroectodermal Tumors Immunologic Factors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Adjuvants, Immunologic |
Neuroepithelioma Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Immunologic Factors Neoplasms, Germ Cell and Embryonal Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Adjuvants, Immunologic Nevi and Melanomas Pharmacologic Actions Neuroendocrine Tumors Melanoma |