Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00980460 · OUTCOME

Disease Status at the End of 2 Courses of Therapy

Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer · Source last updated 2026-06-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
First two cycles of therapy- up to 42 days after enrollment

What was measured

RECIST v 1.1 and serum alphafetoprotein responses are evaluated separately. RECIST v 1.1 complete response (CR) is defined as disappearance of all target lesions and partial response (PR) is defined as reduction of at last 30% in the sum of the longest dimension of all target lesions (CR and PR measured by CT or MRI) between enrollment. Serum alphafetoprotein response is a decrease of at least 90% from the last serum alphafetoprotein measurement from the baseline prior to the start of chemotherapy to the end of cycle 2. This is calculated for HIGH RISK regimen W and HIGH RISK regimen H only.

Analysis population: Thirty-two (32) patients were enrolled to Regiment W. Two were excluded from the analysis: (1)one was ineligible; and (2) one did not have an accurate report of initial AFP. Forty (40) patients were enrolled to Regiment H. Five were excluded from the analysis: (1)four were ineligible; and (2) one did not receive Temsirolimus.

Groups in this outcome

High-risk Group (Regimen W)

(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

High-risk Group (Regimen H)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
High-risk Group (Regimen W)30
High-risk Group (Regimen H)35

Reported measurements

RECIST PR, no AFP response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
High-risk Group (Regimen W)3Not reportedNot reportedNot reportedNot reported
High-risk Group (Regimen H)3Not reportedNot reportedNot reportedNot reported
AFP response, no RECIST response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
High-risk Group (Regimen W)5Not reportedNot reportedNot reportedNot reported
High-risk Group (Regimen H)10Not reportedNot reportedNot reportedNot reported
RECIST response, AFP response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
High-risk Group (Regimen W)6Not reportedNot reportedNot reportedNot reported
High-risk Group (Regimen H)4Not reportedNot reportedNot reportedNot reported
no AFP response, no RECIST response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
High-risk Group (Regimen W)16Not reportedNot reportedNot reportedNot reported
High-risk Group (Regimen H)18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
    title
    RECIST PR, no AFP response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        10
    title
    AFP response, no RECIST response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
    title
    RECIST response, AFP response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        18
    title
    no AFP response, no RECIST response
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      35
    units
    Participants
description
RECIST v 1.1 and serum alphafetoprotein responses are evaluated separately. RECIST v 1.1 complete response (CR) is defined as disappearance of all target lesions and partial response (PR) is defined as reduction of at last 30% in the sum of the longest dimension of all target lesions (CR and PR measured by CT or MRI) between enrollment. Serum alphafetoprotein response is a decrease of at least 90% from the last serum alphafetoprotein measurement from the baseline prior to the start of chemotherapy to the end of cycle 2. This is calculated for HIGH RISK regimen W and HIGH RISK regimen H only.
groups
  1. description
    (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
    id
    OG000
    title
    High-risk Group (Regimen W)
  2. description
    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
    id
    OG001
    title
    High-risk Group (Regimen H)
param Type
NUMBER
population Description
Thirty-two (32) patients were enrolled to Regiment W. Two were excluded from the analysis: (1)one was ineligible; and (2) one did not have an accurate report of initial AFP. Forty (40) patients were enrolled to Regiment H. Five were excluded from the analysis: (1)four were ineligible; and (2) one did not receive Temsirolimus.
reporting Status
POSTED
time Frame
First two cycles of therapy- up to 42 days after enrollment
title
Disease Status at the End of 2 Courses of Therapy
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice