Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00060333
First received: May 6, 2003
Last updated: June 17, 2012
Last verified: July 2009
  Purpose

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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Incidence of local recurrence 2 years after completion of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of regional and systemic metastases [ Designated as safety issue: No ]
  • Survival time [ Designated as safety issue: No ]
  • Failure time [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Fatigue as assessed by the Brief Fatigue Inventory [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2003
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060333

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
United States, Iowa
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, United States, 52501
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, North Dakota
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Barbara A. Pockaj, MD Mayo Clinic Hospital
Investigator: John H. Donohue, MD Mayo Clinic
Investigator: Jan L. Kasperbauer, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Jan C. Buckner, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00060333     History of Changes
Other Study ID Numbers: CDR0000301633, NCCTG-N0275
Study First Received: May 6, 2003
Last Updated: June 17, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage I melanoma
stage II melanoma
stage III melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2014