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NCT03345784 · OUTCOME

Progression-free Survival

Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers · Source last updated 2024-02-20

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years

What was measured

To obtain preliminary information about the progression-free survival of AZD1775 in combination with radiotherapy and concurrent cisplatin in women with locally advanced gynecological cancer. Progression is defined a clinical or radiological using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Groups in this outcome

Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1

Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 1, 3, and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.

Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1

Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 3 and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 13
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -14

Reported measurements

4 Months Post Treatment

Alive and progression-free post-treatment

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 13Not reportedNot reportedNot reportedNot reported
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -14Not reportedNot reportedNot reportedNot reported

Lost to Follow-Up

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 10Not reportedNot reportedNot reportedNot reported
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -10Not reportedNot reportedNot reportedNot reported
2 Years Post Treatment

Alive and progression-free post-treatment

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 13Not reportedNot reportedNot reportedNot reported
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -13Not reportedNot reportedNot reportedNot reported

Lost to Follow-Up

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 10Not reportedNot reportedNot reportedNot reported
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      title
      Alive and progression-free post-treatment
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      Lost to Follow-Up
    title
    4 Months Post Treatment
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      title
      Alive and progression-free post-treatment
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      title
      Lost to Follow-Up
    title
    2 Years Post Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    units
    Participants
description
To obtain preliminary information about the progression-free survival of AZD1775 in combination with radiotherapy and concurrent cisplatin in women with locally advanced gynecological cancer. Progression is defined a clinical or radiological using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
groups
  1. description
    Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 1, 3, and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
    id
    OG000
    title
    Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
  2. description
    Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 3 and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
    id
    OG001
    title
    Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years
title
Progression-free Survival
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice