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Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

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ClinicalTrials.gov Identifier: NCT01014767
Recruitment Status : Terminated (PI departure from coordinating institution)
First Posted : November 17, 2009
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Brain Cancer
Choroid Plexus Tumors
Interventions Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Dactinomycin
Drug: Doxorubicin
Drug: Etoposide
Drug: Irinotecan
Drug: Leucovorin
Drug: Methotrexate
Drug: Temozolomide
Drug: Vincristine
Enrollment 27
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Standard Arm (1) Doxorubicin/Cisplatin Arm (2) Methotrexate Arm (3) Temozolomide Irinotecan Arm (4)
Hide Arm/Group Description 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 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 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 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.
Period Title: Overall Study
Started 12 1 4 1
Completed 0 0 0 0
Not Completed 12 1 4 1
Reason Not Completed
PI left institution, data unavailable             12             1             4             1
Arm/Group Title Standard Arm (1) Doxorubicin/Cisplatin Arm (2) Methotrexate Arm (3) Temozolomide Irinotecan Arm (4) Total
Hide Arm/Group Description Age/Sex unknown- PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available 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. Age/Sex unknown- PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available 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. Age/Sex unknown- PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available 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. Age/Sex unknown- PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available 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. Total of all reporting groups
Overall Number of Baseline Participants 0 0 0 0 0
Hide Baseline Analysis Population Description
PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
Age, Continuous   [1] 
Unit of measure:  PI is no longer with the institution. Al
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
[1]
Measure Description: PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
Sex: Female, Male   [1] 
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Female
Male
[1]
Measure Description: PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
1.Primary Outcome
Title Time to Disease Progression
Hide Description PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
Time Frame Till disease progression or death (up to 6 cycles of 28-day treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
Arm/Group Title Standard Arm (1) Doxorubicin/Cisplatin Arm (2) Methotrexate Arm (3) Temozolomide Irinotecan Arm (4)
Hide Arm/Group Description:
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 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 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 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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Toxicity During First 4 Months of Therapy
Hide Description PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
Time Frame 4 Months
Hide Outcome Measure Data
Hide Analysis Population Description
PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available
Arm/Group Title Standard Arm (1) Doxorubicin/Cisplatin Arm (2) Methotrexate Arm (3) Temozolomide Irinotecan Arm (4)
Hide Arm/Group Description:
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 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 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 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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Serious, and Other [Not Including Serious] Adverse Events data unavailable at sponsoring institution due to departure of PI
Adverse Event Reporting Description Serious, and Other [Not Including Serious] Adverse Events data unavailable at sponsoring institution due to departure of PI
 
Arm/Group Title Standard Arm (1) Doxorubicin/Cisplatin Arm (2) Methotrexate Arm (3) Temozolomide Irinotecan Arm (4)
Hide Arm/Group Description 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 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 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 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.
All-Cause Mortality
Standard Arm (1) Doxorubicin/Cisplatin Arm (2) Methotrexate Arm (3) Temozolomide Irinotecan Arm (4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Arm (1) Doxorubicin/Cisplatin Arm (2) Methotrexate Arm (3) Temozolomide Irinotecan Arm (4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Arm (1) Doxorubicin/Cisplatin Arm (2) Methotrexate Arm (3) Temozolomide Irinotecan Arm (4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Data unavailable at sponsoring institution due to departure of PI. Data were stored and analyzed centrally at another site.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Research Administration
Organization: Tufts Medical Center
Phone: 617-636-1142
EMail: mcoughlin@tuftsmedicalcenter.org
Layout table for additonal information
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01014767     History of Changes
Other Study ID Numbers: CPT-SIOP-2009
First Submitted: November 13, 2009
First Posted: November 17, 2009
Results First Submitted: February 3, 2017
Results First Posted: August 20, 2019
Last Update Posted: August 20, 2019