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Trial · NCT00423293

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)From the start of treatment to 90 daysEligible patients with adverse event information.percentage of participantsNUMBER
SECONDARYNumber of Patients With Major Radiation Planning DeviationsPlanning occurred prior to radiation therapyAll eligible patients who started IMRTParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage of Subjects With Acute Adverse Events (AE)From the start of treatment to 90 daysEligible patients who started protocol treatmentpercentage of participantsNUMBER
SECONDARYPercentage of Subjects With Late Adverse Events (AE)From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 9.2 years.Eligible patients who started IMRT and were on-study \> 90 days from the start of treatment (or did not withdraw consent until after 90 days).percentage of participantsNUMBER
SECONDARYClinical Complete Response Rate8 and 12 weeks after treatment completion (corresponding to 14 and 18 weeks from registration)Eligible patients who started study treatmentpercentage of participantsNUMBER
SECONDARYDuration of Radiotherapy TreatmentFrom start to end of radiation therapy (6 weeks)Eligible patients who started IMRTDaysMEDIAN
SECONDARYFive-year Rate of Overall SurvivalFrom registration to 5 yearsEligible patients who started study treatmentpercentage of participantsNUMBER
SECONDARYFive-year Rate of Disease-free SurvivalFrom registration to 5 yearsEligible patients who started study treatmentpercentage of participantsNUMBER
SECONDARYFive-Year Cumulative Incidence Rate of Local-regional FailureFrom registration to 5 yearsEligible patients who started study treatmentpercentage of participantsNUMBER
SECONDARYFive-Year Cumulative Incidence Rate of Distant FailureFrom registration to 5 yearsEligible patients who started study treatmentpercentage of participantsNUMBER
SECONDARYFive-Year Cumulative Incidence Rate of Colostomy FailureFrom registration to 5 yearsEligible patients who started study treatmentpercentage of participantsNUMBER
SECONDARYFive-Year Rate of Colostomy-free SurvivalFrom registration to 5 yearsEligible patients who started study treatmentpercentage of participantsNUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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