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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00641 | Registry Identifier | CTRP (Clinical Trials Reporting System) | |
| CDR0000301633 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (adjuvant radiation therapy) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 2 years after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 years |
| Survival Time |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara A. Pockaj, MD | Mayo Clinic Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Mayo Clinic - Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27368067 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Adjuvant Radiation Therapy) | Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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. |
| up to 5 years |
| 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. | Time from randomization to death due to any cause or disease progression (up to 5 years) |
| 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. | Up to 5 years |
| 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. | Baseline to up to 3 months |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| Mercy Capitol Hospital | Des Moines | Iowa | 50307 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa | 52501 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | United States |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | United States |
| Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | 58501 | United States |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | United States |
| St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | 58502 | United States |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18105 | United States |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | United States |
| Geisinger Medical Group - Scenery Park | State College | Pennsylvania | 16801 | United States |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Adjuvant Radiation Therapy) | Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of patients with LR | Within 2 years after treatment |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of patients | Up to 5 years |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Posted | Median | 95% Confidence Interval | up to 5 years |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Median | 95% Confidence Interval | Time from randomization to death due to any cause or disease progression (up to 5 years) |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | number of participants | Up to 5 years |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | percentage of participants analyzed | Baseline to up to 3 months |
|
Adverse events were assessed at the end of radiation therapy (RT) every 3 months for 3 years and then every 6 months for 2 more years; Up to 5 years.
This study will utilize the Common Toxicity Criteria (CTC) version 2.0 for adverse event monitoring and reporting. All graded adverse events are reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Adjuvant Radiation Therapy) | Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. | 0 | 20 | 18 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorder | Cardiac disorders | MedDRA 9 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Pain due to radiation | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA 9 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara A. Pockaj, MD | Mayo Clinic | 507/284-3559 | pockaj.barbara@mayo.edu |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 2 (Q02) of the Brief Fatigue Inventory (BFI) which instructs "Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your USUAL level of fatigue during the past 24 hours." |
| OG002 | Treatment (Adjuvant Radiation Therapy) Q03 | Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 3 (Q03) of the Brief Fatigue Inventory (BFI) which instructs "Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during the past 24 hours." |
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