Trial Outcomes & Findings for Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma (NCT NCT00060333)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Within 2 years after treatment

Results posted on

2017-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Adjuvant Radiation Therapy) n=20 Participants 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.
Age, Continuous	68.0 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Adjuvant Radiation Therapy) n=20 Participants 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.	Treatment (Adjuvant Radiation Therapy) Q02 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."	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."
2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence	10 percentage of patients with LR Interval 0.0 to 23.2	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Adjuvant Radiation Therapy) n=20 Participants 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.	Treatment (Adjuvant Radiation Therapy) Q02 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."	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."
Incidence of Regional and Systemic Metastases	5 percentage of patients Interval 0.1 to 24.9	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Adjuvant Radiation Therapy) n=20 Participants 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.	Treatment (Adjuvant Radiation Therapy) Q02 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."	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."
Survival Time	NA (MEDIAN) The median survival time was not reached.	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Adjuvant Radiation Therapy) n=20 Participants 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.	Treatment (Adjuvant Radiation Therapy) Q02 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."	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."
Failure Time	NA (MEDIAN) The median failure time was not reached.	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Adjuvant Radiation Therapy) n=20 Participants 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.	Treatment (Adjuvant Radiation Therapy) Q02 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."	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."
Toxicity	0 number of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Adjuvant Radiation Therapy) n=17 Participants 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.	Treatment (Adjuvant Radiation Therapy) Q02 n=17 Participants 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."	Treatment (Adjuvant Radiation Therapy) Q03 n=17 Participants 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."
Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory Improve	11.8 percentage of participants analyzed	23.5 percentage of participants analyzed	29.4 percentage of participants analyzed
Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory Same	76.5 percentage of participants analyzed	64.7 percentage of participants analyzed	64.7 percentage of participants analyzed
Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory Worsened	11.8 percentage of participants analyzed	11.8 percentage of participants analyzed	5.9 percentage of participants analyzed

Adverse Events

Treatment (Adjuvant Radiation Therapy)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Adjuvant Radiation Therapy) n=20 participants at risk 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.
Cardiac disorders Cardiac disorder	5.0% 1/20 • Number of events 1 • 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.
Gastrointestinal disorders Esophagitis	10.0% 2/20 • Number of events 2 • 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.
General disorders Fatigue	5.0% 1/20 • Number of events 1 • 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.
General disorders Pain due to radiation	25.0% 5/20 • Number of events 8 • 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.
Injury, poisoning and procedural complications Dermatitis radiation	90.0% 18/20 • Number of events 28 • 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.
Investigations INR increased	5.0% 1/20 • Number of events 1 • 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.
Metabolism and nutrition disorders Anorexia	20.0% 4/20 • Number of events 4 • 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.
Metabolism and nutrition disorders Serum sodium decreased	5.0% 1/20 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Alopecia	20.0% 4/20 • Number of events 6 • 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.
Skin and subcutaneous tissue disorders Pruritus	5.0% 1/20 • Number of events 1 • 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.

Additional Information

Barbara A. Pockaj, MD

Mayo Clinic

Phone: 507/284-3559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place