Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)
Both
Melanoma (Skin)
Trial Information
Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma
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.
Inclusion 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 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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Incidence of local recurrence 2 years after completion of study treatment
Safety Issue:
No
Principal Investigator
Barbara A. Pockaj, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000301633
NCT ID:
NCT00060333
Start Date:
July 2003
Completion Date:
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- stage I melanoma
- stage II melanoma
- stage III melanoma
- Melanoma
Name | Location |
|---|---|
| Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
| St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
| Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
| Fairview Southdale Hospital | Edina, Minnesota 55435 |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
| Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
| United Hospital | St. Paul, Minnesota 55102 |
| Ridgeview Medical Center | Waconia, Minnesota 55387 |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
| Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
| Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
| McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
| Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
| Mercy Capitol Hospital | Des Moines, Iowa 50307 |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
| Bismarck Cancer Center | Bismarck, North Dakota 58501 |
| Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
| Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
| St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |
