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

  Show 39 Study Locations
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
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 15, 2014