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Recurrent MelanomaPhase 2NCT00060333

Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

A Phase 2 study testing radiation therapy in people with Recurrent Melanoma, run by Alliance for Clinical Trials in Oncology at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma
What is being tested?
radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
39 sitesUnited States
Study dates
Jul 2003to Apr 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.)

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • McCreery Cancer Center at Ottumwa Regional

    Ottumwa, Iowa, 52501

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
radiation therapy
Keywords
recurrent melanoma, stage I melanoma, stage II melanoma, stage III melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiation therapyRadiation

Study groups in NCT00060333
Study groupRoleWhat they receive
Treatment (adjuvant radiation therapy)ExperimentalWithin 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.
Receives: Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence

    The primary endpoint is the incidence of local recurrence within 2 years after treatment. Local recurrence (LR) is defined as a desmoplastic melanoma lesion recurring within the radiated field. The properties of the binomial distribution will be used to construct a 95% confidence interval for the true 2-year local recurrence rate (LRR). The Kaplan-Meier method will be used if some patients are lost to follow-up.

    Measured: Within 2 years after treatment

Secondary outcomes (5)

  1. Incidence of Regional and Systemic Metastases

    Incidence of regional and systemic metastasis: Incidences will be calculated for each cohort and 95% confidence intervals will be constructed using the properties of the binomial distribution.

    Measured: Up to 5 years

  2. Survival Time

    Survival time: Survival time is defined as the time from randomization to death due to any cause. The median survival time will be estimated using the method of Kaplan-Meier.

    Measured: up to 5 years

  3. Failure Time

    Failure time is defined as the time from randomization to death due to any cause or disease progression. The median failure time will be estimated using the method of Kaplan-Meier.

    Measured: Time from randomization to death due to any cause or disease progression (up to 5 years)

  4. Toxicity

    For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. The number of participants reporting a grade 3 or higher toxicity are reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.

    Measured: Up to 5 years

  5. Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory

    Fatigue Assessment: A portion of the Brief Fatigue Inventory will be used to determine fatigue changes throughout the course of radiation. Patients will fill out the questionnaire at baseline, weekly during radiation, and 3 months after the beginning of radiation. Fatigue will be defined as: minor if the patient answers 0-3 (on a 10 point scale), mild for answers of 4-6, and severe for answers of 7-10. The percentage of patients that have worsened (improved) fatigue from baseline to the radiation stage will be calculated. We will also compare fatigue levels at baseline to the 3 month visit. Worsened fatigue is defined as going from minor to mild, minor to severe, or mild to severe. Improved fatigue is defined as going from severe to mild, severe to minor, or mild to minor.

    Measured: Baseline to up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2003 (estimated)
  2. Study startJul 2003
  3. Primary completionJun 2011
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00060333
Sponsor's protocol ID
NCCTG-N0275
Other IDs
NCI-2009-00641, CDR0000301633
Status last verified
Jan 2017
First submitted
6 May 2003
Last updated
17 Mar 2017
Data monitoring committee
Yes

Publications

  • Rule WG, Allred JB, Pockaj BA, Markovic SN, DiCaudo DJ, Erickson LA, Deming RL, Schild SE. Results of NCCTG N0275 (Alliance) - a phase II trial evaluating resection followed by adjuvant radiation therapy for patients with desmoplastic melanoma. Cancer Med. 2016 Aug;5(8):1890-6. doi: 10.1002/cam4.783. Epub 2016 Jul 1.

    PubMed 27368067

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing radiation therapy in people with Recurrent Melanoma, run by Alliance for Clinical Trials in Oncology at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence (time frame: Within 2 years after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00060333, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.

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Clinical Trial NCT00060333 | AzTrials