Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00060333
First received: May 6, 2003
Last updated: August 12, 2016
Last verified: August 2016

May 6, 2003
August 12, 2016
July 2003
June 2011   (final data collection date for primary outcome measure)
Incidence of local recurrence [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00060333 on ClinicalTrials.gov Archive Site
  • Incidence of regional and systemic metastases [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Survival time [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Failure time [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events assessed using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Change in fatigue as assessed by the Brief Fatigue Inventory [ Time Frame: Baseline to up to 3 months ] [ 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
This phase II trial is studying how well adjuvant radiation therapy works in treating patients who have undergone surgery for desmoplastic melanoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery may kill any tumor cells remaining after surgery.

PRIMARY OBJECTIVES:

I. Assess the recurrence rates in patients with desmoplastic melanoma (DM) >= 1 mm deep treated with adjuvant radiotherapy after surgical resection.

II. Assess recurrence rates in patients with locally recurrent DM treated with adjuvant radiotherapy after surgical resection.

SECONDARY OBJECTIVES:

I. Evaluate the impact of adjuvant radiation therapy after surgical resection on disease free and overall survival.

II. Evaluate the immediate and long-term morbidity of the addition of radiotherapy to surgery.

OUTLINE:

Within 8 weeks after surgical resection, patients undergo radiation therapy twice weekly over approximately 2.5 weeks for a total of 5 fractions in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Melanoma
Radiation: radiation therapy
Experimental: Treatment (adjuvant radiation therapy)
Within 8 weeks after surgical resection, patients undergo radiation therapy twice weekly over approximately 2.5 weeks for a total of 5 fractions in the absence of disease progression or unacceptable toxicity.
Intervention: Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Not Provided
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Pathologically proven DM >= 1 mm in depth or locally recurrent DM; recurrent tumor is defined as a tumor found =< 2 cm from the previous excision or within the surgical bed (which includes the extent of previous skin flaps)
  • DM resected with pathologically negative margins; acceptable surgery includes standard wide local excision and Moh's surgery

    • Tumors on the trunk proximal extremities need to have a >= 2 cm negative margin; tumors located on the head and neck and distal extremities will have an attempt at 2 cm negative margins but due to location and subsequent concern regarding cosmesis a margin < 2 cm will be acceptable if margin is negative
    • Margins from tumors resected using the Moh's technique will be accepted if negative and best approximation of tumor width will be made
  • Radiation therapy (RT) is to begin =< 8 weeks after definitive surgical resection
  • Adjuvant systemic therapy (immunotherapy or chemotherapy) must be postponed until irradiation is completed

Exclusion Criteria

  • Previous irradiation to the same site
  • Non-healing surgical wound
  • Active infection at the surgical site
  • Evidence of metastatic disease; local nodal disease is still eligible for the trial
  • Life expectancy < 1 year
  • Melanoma with focally desmoplastic features, in which the desmoplastic melanoma is not the predominant histologic pattern of the tumor, will be excluded; non-desmoplastic neurotropic melanoma and non-desmoplastic spindle cell melanoma are also excluded
  • Previous malignancy < 5 years excluding basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ (with the exception of patients who have stage I breast cancer who were adequately treated with adjuvant therapy and are currently disease free, and patients with stage I or II prostate cancer treated with prostatectomy or radiotherapy and are biochemically free of disease [for radical retropubic prostatectomy (RRP) prostate-specific antigen (PSA) < 0.3 and for radiotherapy PSA < 2.0 above the post treatment nadir])
  • Any of the following:

    • Pregnant women
    • Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, abstinence, etc.)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00060333
NCCTG-N0275, NCI-2009-00641, CDR0000301633
Yes
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Barbara A. Pockaj, MD Mayo Clinic Hospital
Alliance for Clinical Trials in Oncology
August 2016

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