Trial Outcomes & Findings for Radiation Therapy and Concurrent Cisplatin Chemotherapy for Locally Advanced or Metastatic Malignant Melanoma (NCT NCT00707161)
NCT ID: NCT00707161
Last Updated: 2017-03-31
Results Overview
Response rate of melanoma lesions was measured after treated with the trial agent.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
2005-2010
Results posted on
2017-03-31
Participant Flow
Participant milestones
| Measure |
Treatment Arm (Radiation Therapy & Cisplatin)
All patients will receive Radiation Therapy and Cisplatin for their melanoma. If appropriate patients will have surgical resection for residual or recurrent melanoma following chemoradiation.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Treatment Arm (Radiation Therapy & Cisplatin)
All patients will receive Radiation Therapy and Cisplatin for their melanoma. If appropriate patients will have surgical resection for residual or recurrent melanoma following chemoradiation.
|
|---|---|
|
Overall Study
Physician Decision
|
6
|
Baseline Characteristics
Radiation Therapy and Concurrent Cisplatin Chemotherapy for Locally Advanced or Metastatic Malignant Melanoma
Baseline characteristics by cohort
| Measure |
Treatment Arm (Radiation Therapy & Cisplatin)
n=6 Participants
Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2005-2010Population: Study terminated. Analysis not conducted.
Response rate of melanoma lesions was measured after treated with the trial agent.
Outcome measures
Outcome data not reported
Adverse Events
Treatment Arm (Radiation Therapy & Cisplatin)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place