Trial · NCT01349322
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With In-breast Recurrence (Local Failure) | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are reported here. | Eligible population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here. | Eligible population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive Without Disease | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here. | Eligible population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive Without Distant Disease | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here. | Eligible population | percentage of participants | NUMBER |
| SECONDARY | Number of Participants by Highest Grade Adverse Event Reported as Definitely, Probably, or Possibly Related to Protocol Treatment | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. | Adverse event population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis Subscale Score From Baseline to 3 Years | Baseline and 3 years | Quality of life population, with data at baseline and 3 years. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With a Physician-reported Cosmetic Score of Excellent or Good at 3 Years | 3 years | Quality of life population, with data at 3 years. | percentage of participants | NUMBER |
| SECONDARY | Correlation Between Dose-volume Data and Both Adverse Events and Efficacy | From randomization to end of follow-up. | |||
| SECONDARY | Translational Research of Single Nucleotide Polymorphisms (SNPs) in Transforming Growth Factor Beta 1 (TGFB1) and Ataxia-Telangiesctasia Mutated (ATM) Genes | From randomization to last follow-up. | The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified analysis, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial. | ||
| SECONDARY | Treatment Cost | From randomization to end of treatment. | |||
| OTHER_PRE_SPECIFIED | Percentage of Participants With In-breast Recurrence (Local Failure) by Race | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are reported here. | Eligible population. Data stratified by race. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With In-breast Recurrence (Local Failure) by Ethnicity | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are reported here. | Eligible population. Data stratified by ethnicity. | percentage of participants | NUMBER |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01349322/outcomes