Trial Outcomes & Findings for Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors (NCT NCT01014767)
NCT ID: NCT01014767
Last Updated: 2019-08-20
Results Overview
PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
TERMINATED
PHASE3
27 participants
Till disease progression or death (up to 6 cycles of 28-day treatment)
2019-08-20
Participant Flow
PI left institution prior to completion of project. 27 cases are listed in linked abstracted. (Arm A=12, Arm B=1, Arm C=4, Arm D=1, Observation = 3 and Unknown=6) PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available.
PI left institution prior to completion of project. 27 cases are listed in linked abstracted. (Arm A=12, Arm B=1, Arm C=4, Arm D=1, Observation = 3 and Unknown=6) PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available.
Participant milestones
| Measure |
Standard Arm (1)
Alternating chemotherapy cycles with etoposide 100 mg/m2 over 1 hour on days 1-5, carboplatin 350 mg/m2 over 2 hours on day 2 and 3, vincristine 1.5 mg/m2 on day 5 alternating with: etoposide 100 mg/m2 over 1 hour on days 1-5, cyclophosphamide 1 g/m2 over 1 hour on day 2 and 3, vincristine 1.5 mg/m2 on day 5. Six blocks are given in 4 week intervals (day1 to day1). Radiation is given between the second and the third cycle only to a small subgroup of patients defined by age histology staging and response to the first to cycles of chemotherapy.
|
Doxorubicin/Cisplatin Arm (2)
Doxorubicin 25 mg/m²/day over 12 hrs on days 1-3, Dactinomycin 45 µg/kg/day (max. 2 mg), i.v. on day 1, and Cisplatin 70 mg/m²/d over 6 hrs on day 4, and Vincristine 1.5 mg/m²/day (max. 2 mg), i.v. on days 8, 15. An identical second cycle is started on day 28 if the side effects allow it. The further treatment is identical to the standard arm with four more cycles of chemotherapy following radiation in some of the patients in all treatment arms.
|
Methotrexate Arm (3)
Methotrexate 5g/m\^2 over 24 hours with leucovorin rescue at hour 42 given three times on days 1 15 and 29. The further treatment is identical in all four treatment arms.
|
Temozolomide Irinotecan Arm (4)
Temozolomide is given at 150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day x 5 days as one hour infusions. Two of these cycles are followed by the common radiation - four cycle chemotherapy protocol.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
1
|
4
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
1
|
4
|
1
|
Reasons for withdrawal
| Measure |
Standard Arm (1)
Alternating chemotherapy cycles with etoposide 100 mg/m2 over 1 hour on days 1-5, carboplatin 350 mg/m2 over 2 hours on day 2 and 3, vincristine 1.5 mg/m2 on day 5 alternating with: etoposide 100 mg/m2 over 1 hour on days 1-5, cyclophosphamide 1 g/m2 over 1 hour on day 2 and 3, vincristine 1.5 mg/m2 on day 5. Six blocks are given in 4 week intervals (day1 to day1). Radiation is given between the second and the third cycle only to a small subgroup of patients defined by age histology staging and response to the first to cycles of chemotherapy.
|
Doxorubicin/Cisplatin Arm (2)
Doxorubicin 25 mg/m²/day over 12 hrs on days 1-3, Dactinomycin 45 µg/kg/day (max. 2 mg), i.v. on day 1, and Cisplatin 70 mg/m²/d over 6 hrs on day 4, and Vincristine 1.5 mg/m²/day (max. 2 mg), i.v. on days 8, 15. An identical second cycle is started on day 28 if the side effects allow it. The further treatment is identical to the standard arm with four more cycles of chemotherapy following radiation in some of the patients in all treatment arms.
|
Methotrexate Arm (3)
Methotrexate 5g/m\^2 over 24 hours with leucovorin rescue at hour 42 given three times on days 1 15 and 29. The further treatment is identical in all four treatment arms.
|
Temozolomide Irinotecan Arm (4)
Temozolomide is given at 150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day x 5 days as one hour infusions. Two of these cycles are followed by the common radiation - four cycle chemotherapy protocol.
|
|---|---|---|---|---|
|
Overall Study
PI left institution, data unavailable
|
12
|
1
|
4
|
1
|
Baseline Characteristics
Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Till disease progression or death (up to 6 cycles of 28-day treatment)Population: PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 MonthsPopulation: PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
Outcome measures
Outcome data not reported
Adverse Events
Standard Arm (1)
Doxorubicin/Cisplatin Arm (2)
Methotrexate Arm (3)
Temozolomide Irinotecan Arm (4)
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