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Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

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

May 6, 2003
June 17, 2012
July 2003
June 2011   (final data collection date for primary outcome measure)
Incidence of local recurrence 2 years after completion of study treatment [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00060333 on Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma
Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma

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.


  • 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.

Phase 2
Primary Purpose: Treatment
Melanoma (Skin)
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
June 2011   (final data collection date for primary outcome measure)


  • 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)



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 1 year


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • No concurrent adjuvant immunotherapy


  • No concurrent adjuvant chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy to the focused site of this study


  • See Disease Characteristics
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000301633, NCCTG-N0275
Not Provided
Jan C. Buckner, North Central Cancer Treatment Group
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Barbara A. Pockaj, MD Mayo Clinic Hospital
Investigator: John H. Donohue, MD Mayo Clinic
Investigator: Jan L. Kasperbauer, MD Mayo Clinic
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP