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Last Modified: 6/25/2009     First Published: 4/23/2003  
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Phase II Study of Adjuvant Radiotherapy After Resection in Patients With Desmoplastic Melanoma

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overNCINCCTG-N0275
N0275, NCT00060333

Objectives

  1. Determine the recurrence rates of patients with desmoplastic melanoma treated with adjuvant radiotherapy after surgical resection.
  2. Determine the disease-free and overall survival of patients treated with this regimen.
  3. Determine the immediate and long-term morbidity of patients treated with this regimen.

Entry 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)


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

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

Expected Enrollment

40

A total of 40 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Incidence of local recurrence 2 years after completion of study treatment

Secondary Outcome(s)

Incidence of regional and systemic metastases
Survival time
Failure time
Toxicity
Fatigue as assessed by the Brief Fatigue Inventory

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Barbara Pockaj, MD, Protocol chair
Ph: 507-538-7623
Email: cancerclinicaltrials@mayo.edu
John Donohue, MD, Protocol co-chair
Ph: 507-538-7623
Email: cancerclinicaltrials@mayo.edu
Jan Kasperbauer, MD, Protocol co-chair
Ph: 507-538-7623
Email: cancerclinicaltrials@mayo.edu

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Florida
  Jacksonville
 Mayo Clinic - Jacksonville
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Illinois
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kendrith Rowland, MD
Ph: 217-383-3019
Iowa
  Des Moines
 CCOP - Iowa Oncology Research Association
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital
Ph: 515-241-8704
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center
Ph: 515-241-6727
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Mercy Capitol Hospital
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
  Ottumwa
 McCreery Cancer Center at Ottumwa Regional
 Robert Behrens
Ph: 641-684-2946
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Wender, MD, PhD
Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Wender, MD, PhD
Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Wender, MD, PhD
Ph: 712-252-0088
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Maplewood
 Minnesota Oncology Hematology, PA - Maplewood
 Patrick Flynn, MD
Ph: 612-863-8585
  Minneapolis
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick Flynn, MD
Ph: 612-863-8585
 Park Nicollet Cancer Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Saint Paul
 United Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Waconia
 Ridgeview Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Patrick Flynn, MD
Ph: 612-863-8585
North Dakota
  Bismarck
 Bismarck Cancer Center
 Edward Wos, DO
Ph: 701-323-5741
 Medcenter One Hospital Cancer Care Center
 Edward Wos, DO
Ph: 701-323-5741
 Mid Dakota Clinic, PC
 Clinical Trials Office - Mid Dakota Clinic, PC
Ph: 701-530-6950
 St. Alexius Medical Center Cancer Center
 Clinical Trials Office - St. Alexius Medical Center Cancer Center
Ph: 701-530-6950
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Suresh Nair, MD
Ph: 610-402-0512
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Clinical Trials Office - Geisinger Cancer Institute
Ph: 570-271-5251
  State College
 Geisinger Medical Group - Scenery Park
 David Sheldon
Ph: 814-231-4560
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Ph: 570-271-5251
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Loren Tschetter, MD
Ph: 605-328-8000
 Medical X-Ray Center, PC
 Loren Tschetter, MD
Ph: 605-328-8000
 Sanford Cancer Center at Sanford USD Medical Center
 Clinical Trials Office - Sanford Cancer Center
Ph: 605-328-1367

Registry Information
Official Title Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma
Trial Start Date 2003-07-11
Trial Completion Date 2006-10-23 (estimated)
Registered in ClinicalTrials.gov NCT00060333
Date Submitted to PDQ 2003-03-31
Information Last Verified 2009-06-25
NCI Grant/Contract Number CA25224

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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