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Home > "A" Clinical Trials Conditions > Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma



Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

For Condition: stage 3 melanoma,stage 1 melanoma,Recurrent Melanoma,stage 2 melanoma
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of adjuvant radiation therapy in treating patients who have resecteddesmoplastic melanoma.
Details: 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. 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 1 year Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No nonhealing surgical wound - No active infection at the surgical site PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent adjuvant immunotherapy Chemotherapy - No concurrent adjuvant chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the focused site of this study Surgery - See Disease Characteristics
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BarbaraPockaj,  Study Chair,  Mayo Clinic Scottsdale

CCOP - Wichita *Recruiting*
Wichita,  Kansas,  67214-3882
United States
Recruiting Shaker  Dakhil 316-268-5784

Mayo Clinic Cancer Center *Recruiting*
Rochester,  Minnesota,  55905
United States
Recruiting Steven  Alberts 507-284-2511

CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls,  South Dakota,  57104
United States
Recruiting Loren  Tschetter 605-328-8044

CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids,  Iowa,  52403-1206
United States
Recruiting Martin  Wiesenfeld 319-363-8303

Rapid City Regional Hospital *Recruiting*
Rapid City,  South Dakota,  57709
United States
Recruiting Larry  Ebbert 605-341-8704

CCOP - Dayton *Recruiting*
Dayton,  Ohio,  45429
United States
Recruiting Howard  Gross 937-395-8678

Medcenter One Health System *Recruiting*
Bismark,  North Dakota,  58501-5505
United States
Recruiting Edward  Wos 701-323-5741

CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale,  Arizona,  85259-5404
United States
Recruiting Barbara  Pockaj 480-301-8000

Mayo Clinic *Recruiting*
Jacksonville,  Florida,  32224
United States
Recruiting Edith  Perez 904-953-0118

CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines,  Iowa,  50309-1016
United States
Recruiting Roscoe  Morton 515-244-7586

Siouxland Hematology-Oncology *Recruiting*
Sioux City,  Iowa,  51101-1733
United States
Recruiting Donald  Wender 712-252-0088

CCOP - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-4083


Additional Information:
Study ID Numbers:
  CDR0000301633;  NCCTG-N0275
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060333

Other Stage 3 Melanoma Studies:
1. Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

2. Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma

3. Vaccine Therapy in Treating Patients With Melanoma

4. Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma

5. Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed

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