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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00060333
Other study ID # NCCTG-N0275
Secondary ID NCI-2009-00641CD
Status Active, not recruiting
Phase Phase 2
First received May 6, 2003
Last updated August 12, 2016
Start date July 2003

Study information

Verified date August 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Radiation:
radiation therapy


Locations

Country Name City State
United States Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania
United States Bismarck Cancer Center Bismarck North Dakota
United States Medcenter One Hospital Cancer Care Center Bismarck North Dakota
United States Mid Dakota Clinic, PC Bismarck North Dakota
United States St. Alexius Medical Center Cancer Center Bismarck North Dakota
United States Fairview Ridges Hospital Burnsville Minnesota
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa
United States Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa
United States Mercy Capitol Hospital Des Moines Iowa
United States Fairview Southdale Hospital Edina Minnesota
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois
United States Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States McCreery Cancer Center at Ottumwa Regional Ottumwa Iowa
United States Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Cancer Center Saint Louis Park Minnesota
United States United Hospital Saint Paul Minnesota
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa
United States St. Luke's Regional Medical Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States Medical X-Ray Center, PC Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States Geisinger Medical Group - Scenery Park State College Pennsylvania
United States Ridgeview Medical Center Waconia Minnesota
United States Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania
United States Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of local recurrence Up to 2 years No
Secondary Incidence of regional and systemic metastases Up to 5 years No
Secondary Survival time up to 5 years No
Secondary Failure time up to 5 years No
Secondary Incidence of adverse events assessed using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0 Up to 5 years Yes
Secondary Change in fatigue as assessed by the Brief Fatigue Inventory Baseline to up to 3 months No
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