NCT00335556 · OUTCOME

Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)

Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors · Source last updated 2017-07-21

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

Measure: NUMBER
Unit: Percentage of 4-year OS
Interval / dispersion: 95% Confidence Interval
Time frame: 4 years

What was measured

Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS-5 (NCT00002610).

Analysis population: Eligible patients with Stage II-IV DAWT.

Groups in this outcome

UH-1

Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.

Window/UH-1

Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.

UH-2

Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.

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

Analysis denominator · Participants

Group	Source count
UH-1	52
Window/UH-1	4
UH-2	10

Reported measurements

Source class 1

Values in Percentage of 4-year OS · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
UH-1	76.1	Not reported	62.5	89.6	Not reported
Window/UH-1	25.0	Not reported	0	67.4	Not reported
UH-2	87.5	Not reported	64.6	100.0	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Num Sides
TWO_SIDED
ci Pct Value
95
group Description
The event-free survival distributions of patients with Stage II-IV diffuse anaplastic Wilms' tumor on AREN0321 and NWTS-5 (NCT00002610) were compared using the log-rank test.
group Ids
OG000
OG001
OG002
non Inferiority Type
OTHER
p Value
.0199
param Type
Log Rank Test Statistic
param Value
5.4190
statistical Method
Log Rank

Complete source fields

analyses

ci Num Sides
TWO_SIDED
ci Pct Value
95
group Description
The event-free survival distributions of patients with Stage II-IV diffuse anaplastic Wilms' tumor on AREN0321 and NWTS-5 (NCT00002610) were compared using the log-rank test.
group Ids
OG000
OG001
OG002
non Inferiority Type
OTHER
p Value
.0199
param Type
Log Rank Test Statistic
param Value
5.4190
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
62.5
upper Limit
89.6
value
76.1
group Id
OG001
lower Limit
0
upper Limit
67.4
value
25.0
group Id
OG002
lower Limit
64.6
upper Limit
100.0
value
87.5

denoms

counts
group Id
OG000
value
52
group Id
OG001
value
4
group Id
OG002
value
10
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
id
OG000
title
UH-1
description
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
id
OG001
title
Window/UH-1
description
Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
id
OG002
title
UH-2

param Type

NUMBER

population Description

Eligible patients with Stage II-IV DAWT.

reporting Status

POSTED

time Frame

4 years

title

Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)

type

PRIMARY

unit Of Measure

Percentage of 4-year OS

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

Preserved source evidence · Not medical advice