| Phase II Study of Adjuvant Radiotherapy After Resection in Patients With Desmoplastic Melanoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Closed | 18 and over | NCCTG-N0275
N0275, NCT00060333 |
Objectives - Determine the recurrence rates of patients with desmoplastic melanoma treated with adjuvant radiotherapy after surgical resection.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the immediate and long-term morbidity of patients treated with this regimen.
Entry Criteria Disease Characteristics:
- Histologically confirmed desmoplastic melanoma
- Locally recurrent OR at least 1 mm in depth
- Recurrent tumor is defined as a tumor found no more than 2 cm from the previous excision or within the surgical bed (which includes the extent of previous skin flaps)
- Disease resected using standard wide resection or Moh's surgery
- Histologically negative margins
- Tumors on proximal extremities must have a 2 cm negative margin
- Tumors on the head or neck or distal extremities may have margins less than 2 cm provided they are negative
- No melanoma with focally desmoplastic features, in which the desmoplastic melanoma is not the predominant histologic pattern of the tumor
- No nondesmoplastic neurotropic or nondesmoplastic spindle cell melanoma
- No evidence of metastatic disease (local nodal disease allowed)
Prior/Concurrent Therapy:
Biologic therapy - No concurrent adjuvant immunotherapy
Chemotherapy - No concurrent adjuvant chemotherapy
Endocrine therapy Radiotherapy - No prior radiotherapy to the focused site of this study
Surgery - See Disease Characteristics
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal Other - Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except for the following diseases:
- Basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Stage I breast cancer adequately treated with adjuvant therapy for which the patient is currently disease-free
- Stage I or II prostate cancer treated with prostatectomy or radiotherapy with a biochemically-free disease status (i.e., for radical retropubic prostatectomy prostate-specific antigen [PSA] < 0.3 and for radiotherapy PSA < 2.0 above the post-treatment nadir)
- No nonhealing surgical wound
- No active infection at the surgical site
Expected Enrollment 40A total of 40 patients will be accrued for this study. Outcomes Primary Outcome(s)Incidence of local recurrence 2 years after completion of study treatment
Secondary Outcome(s)Incidence of regional and systemic metastases
Survival time
Failure time
Toxicity
Fatigue as assessed by the Brief Fatigue Inventory
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.
Trial Contact Information
Trial Lead Organizations North Central Cancer Treatment Group  | | | | Barbara Pockaj, MD, Protocol chair | | | | | John Donohue, MD, Protocol co-chair | | | | | Jan Kasperbauer, MD, Protocol co-chair | | | |
| Registry Information | | | Official Title | | Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma | | | Trial Start Date | | 2003-07-11 | | | Trial Completion Date | | 2006-10-23 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00060333 | | | Date Submitted to PDQ | | 2003-03-31 | | | Information Last Verified | | 2009-07-31 | | | NCI Grant/Contract Number | | CA25224 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
