Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer
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ClinicalTrials.gov Identifier: NCT00980460 |
Recruitment Status :
Active, not recruiting
First Posted : September 21, 2009
Results First Posted : December 28, 2021
Last Update Posted : June 28, 2022
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
PRETEXT Stage 1 Hepatoblastoma PRETEXT Stage 2 Hepatoblastoma PRETEXT Stage 3 Hepatoblastoma PRETEXT Stage 4 Hepatoblastoma |
Interventions |
Drug: Cisplatin Drug: Dexrazoxane Drug: Doxorubicin Hydrochloride Drug: Fluorouracil Drug: Irinotecan Hydrochloride Other: Laboratory Biomarker Analysis Procedure: Liver Transplantation Drug: Temsirolimus Procedure: Therapeutic Conventional Surgery Drug: Vincristine Sulfate |
Enrollment | 236 |
Recruitment Details | Study opened for enrollment on 09/14/2009 and closed on 07/20/2018 |
Pre-assignment Details |
Arm/Group Title | Very Low-risk Group | Low-risk Group (Regimen T) | Intermediate-risk Group (Regimen F) | High-risk Group (Regimen W) | High-risk Group (Regimen H) |
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Patients undergo surgery and then receive no further treatment. Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery |
Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV |
Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012) Cisplatin: Given IV Dexrazoxane: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV |
(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV |
Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Temsirolimus: Given IV Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV |
Period Title: Overall Study | |||||
Started | 8 | 51 | 105 | 32 | 40 |
Completed | 8 | 47 | 70 | 14 | 24 |
Not Completed | 0 | 4 | 35 | 18 | 16 |
Reason Not Completed | |||||
Death | 0 | 0 | 1 | 2 | 1 |
Lack of Efficacy | 0 | 0 | 10 | 6 | 8 |
Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
Physician Decision | 0 | 0 | 11 | 5 | 3 |
Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 |
Ineligible | 0 | 2 | 3 | 1 | 4 |
Refusal of further therapy | 0 | 2 | 3 | 2 | 0 |
No therapy within 42 days of resection | 0 | 0 | 3 | 1 | 0 |
No transplant by protocol timepoints | 0 | 0 | 3 | 0 | 0 |
Arm/Group Title | Very Low-risk Group | Low-risk Group (Regimen T) | Intermediate-risk Group (Regimen F) | High-risk Group (Regimen W) | High-risk Group (Regimen H) | Total | |
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Patients undergo surgery and then receive no further treatment. Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery |
Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV |
Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012) Cisplatin: Given IV Dexrazoxane: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV |
(regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV |
Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Temsirolimus: Given IV Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV |
Total of all reporting groups | |
Overall Number of Baseline Participants | 8 | 51 | 105 | 32 | 40 | 236 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 51 participants | 105 participants | 32 participants | 40 participants | 236 participants | |
<=18 years |
8 100.0%
|
51 100.0%
|
105 100.0%
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32 100.0%
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40 100.0%
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236 100.0%
|
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Between 18 and 65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 8 participants | 51 participants | 105 participants | 32 participants | 40 participants | 236 participants | |
2.5 (2.56) | 1.59 (1.71) | 1.42 (2.61) | 2.31 (2.4) | 2.75 (2.9) | 1.84 (2.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 51 participants | 105 participants | 32 participants | 40 participants | 236 participants | |
Female |
1 12.5%
|
15 29.4%
|
43 41.0%
|
12 37.5%
|
13 32.5%
|
84 35.6%
|
|
Male |
7 87.5%
|
36 70.6%
|
62 59.0%
|
20 62.5%
|
27 67.5%
|
152 64.4%
|
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||
Number Analyzed | 8 participants | 51 participants | 105 participants | 32 participants | 40 participants | 236 participants | |
Hispanic or Latino |
1 12.5%
|
13 25.5%
|
27 25.7%
|
10 31.3%
|
16 40.0%
|
67 28.4%
|
|
Not Hispanic or Latino |
7 87.5%
|
35 68.6%
|
73 69.5%
|
22 68.8%
|
23 57.5%
|
160 67.8%
|
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Unknown or Not Reported |
0 0.0%
|
3 5.9%
|
5 4.8%
|
0 0.0%
|
1 2.5%
|
9 3.8%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||
Number Analyzed | 8 participants | 51 participants | 105 participants | 32 participants | 40 participants | 236 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
1 12.5%
|
5 9.8%
|
8 7.6%
|
2 6.3%
|
6 15.0%
|
22 9.3%
|
|
Native Hawaiian or Other Pacific Islander |
1 12.5%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 0.4%
|
|
Black or African American |
1 12.5%
|
6 11.8%
|
7 6.7%
|
6 18.8%
|
3 7.5%
|
23 9.7%
|
|
White |
5 62.5%
|
29 56.9%
|
75 71.4%
|
20 62.5%
|
25 62.5%
|
154 65.3%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
11 21.6%
|
15 14.3%
|
4 12.5%
|
6 15.0%
|
36 15.3%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 8 participants | 51 participants | 105 participants | 32 participants | 40 participants | 236 participants |
United States | 8 | 50 | 98 | 30 | 37 | 223 | |
Canada | 0 | 1 | 4 | 2 | 0 | 7 | |
Australia | 0 | 0 | 3 | 0 | 0 | 3 | |
Japan | 0 | 0 | 0 | 0 | 3 | 3 |
Name/Title: | Results Reporting Coordinator |
Organization: | Children's Oncology Group |
Phone: | 626-447-0064 |
EMail: | resultsreportingcoordinator@childrensoncologygroup.org |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00980460 |
Obsolete Identifiers: | NCT02265692 |
Other Study ID Numbers: |
NCI-2011-01975 NCI-2011-01975 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) AHEP0731 10-00098 COG-AHEP0731 CDR0000654889 AHEP0731 ( Other Identifier: Children's Oncology Group ) AHEP0731 ( Other Identifier: CTEP ) U10CA180886 ( U.S. NIH Grant/Contract ) U10CA098543 ( U.S. NIH Grant/Contract ) |
First Submitted: | September 18, 2009 |
First Posted: | September 21, 2009 |
Results First Submitted: | August 4, 2021 |
Results First Posted: | December 28, 2021 |
Last Update Posted: | June 28, 2022 |