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Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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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 ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Bismarck Cancer CenterBismarck, North Dakota  58501
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502