NCT00941070 · OUTCOME

Progression Free Survival by Smoking Status

Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer · Source last updated 2017-11-17

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

Measure: NUMBER
Unit: percentage of paticipants
Interval / dispersion: 95% Confidence Interval
Time frame: at 18 months from study entry

What was measured

Percent of patients that were progression free by smoking status

Groups in this outcome

Treatment (Cisplatin, Triapine, Radiation Therapy)

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated. Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

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
Treatment (Cisplatin, Triapine, Radiation Therapy)	25

Reported measurements

Non-Smokers

Values in percentage of paticipants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Treatment (Cisplatin, Triapine, Radiation Therapy)	76	Not reported	62	90	Not reported

Smokers that quit while on study

Values in percentage of paticipants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Treatment (Cisplatin, Triapine, Radiation Therapy)	89	Not reported	79	99	Not reported

Smokers

Values in percentage of paticipants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Treatment (Cisplatin, Triapine, Radiation Therapy)	50	Not reported	25	75	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
62
upper Limit
90
value
76
title
Non-Smokers
categories
measurements
group Id
OG000
lower Limit
79
upper Limit
99
value
89
title
Smokers that quit while on study
categories
measurements
group Id
OG000
lower Limit
25
upper Limit
75
value
50
title
Smokers

denoms

counts
group Id
OG000
value
25
units
Participants

description

Percent of patients that were progression free by smoking status

dispersion Type

95% Confidence Interval

groups

description
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated. Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.
id
OG000
title
Treatment (Cisplatin, Triapine, Radiation Therapy)

param Type

NUMBER

reporting Status

POSTED

time Frame

at 18 months from study entry

title

Progression Free Survival by Smoking Status

type

POST_HOC

unit Of Measure

percentage of paticipants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice