Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma - Full Text View

Sponsors and Collaborators:	North Central Cancer Treatment Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00060333

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 II

MedlinePlus related topics: Cancer Melanoma Radiation Therapy Surgery

U.S. FDA Resources

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

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
Estimated Primary Completion Date:	October 2006 (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 64 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	North Central Cancer Treatment Group ( Jan C. Buckner )
Study ID Numbers:	CDR0000301633, NCCTG-N0275
Study First Received:	May 6, 2003
Last Updated:	April 26, 2009
ClinicalTrials.gov Identifier:	NCT00060333 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent melanoma
stage I melanoma
stage II melanoma
stage III melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Immunologic Factors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Adjuvants, Immunologic

Neuroepithelioma
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Neoplasms, Germ Cell and Embryonal
Physiological Effects of Drugs

Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Nevi and Melanomas
Pharmacologic Actions
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 06, 2009