Recurrent Melanoma
Conditions
Keywords
recurrent melanoma, stage I melanoma, stage II melanoma, stage III melanoma
Brief 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.
Detailed 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.
Interventions
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence | Within 2 years after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Regional and Systemic Metastases | Up to 5 years | 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. |
| Survival Time | up to 5 years | 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. |
| Failure Time | Time from randomization to death due to any cause or disease progression (up to 5 years) | 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. |
| Toxicity | Up to 5 years | 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. |
| Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory | Baseline to up to 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Treatment (Adjuvant Radiation Therapy) |
|---|---|
| Age, Continuous | 68.0 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Within 2 years after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Adjuvant Radiation Therapy) | 2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence | 10 percentage of patients with LR |
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.
Time frame: Baseline to up to 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Adjuvant Radiation Therapy) | Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory | Same | 76.5 percentage of participants analyzed |
| Treatment (Adjuvant Radiation Therapy) | Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory | Improve | 11.8 percentage of participants analyzed |
| Treatment (Adjuvant Radiation Therapy) | Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory | Worsened | 11.8 percentage of participants analyzed |
| Treatment (Adjuvant Radiation Therapy) Q02 | Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory | Same | 64.7 percentage of participants analyzed |
| Treatment (Adjuvant Radiation Therapy) Q02 | Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory | Improve | 23.5 percentage of participants analyzed |
| Treatment (Adjuvant Radiation Therapy) Q02 | Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory | Worsened | 11.8 percentage of participants analyzed |
| Treatment (Adjuvant Radiation Therapy) Q03 | Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory | Improve | 29.4 percentage of participants analyzed |
| Treatment (Adjuvant Radiation Therapy) Q03 | Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory | Worsened | 5.9 percentage of participants analyzed |
| Treatment (Adjuvant Radiation Therapy) Q03 | Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory | Same | 64.7 percentage of participants analyzed |
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.
Time frame: Time from randomization to death due to any cause or disease progression (up to 5 years)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Adjuvant Radiation Therapy) | Failure Time | NA |
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.
Time frame: Up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Adjuvant Radiation Therapy) | Incidence of Regional and Systemic Metastases | 5 percentage of patients |
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.
Time frame: up to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Adjuvant Radiation Therapy) | Survival Time | NA |
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.
Time frame: Up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Adjuvant Radiation Therapy) | Toxicity | 0 number of participants |