Trial · NCT03141359
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Progression Free and Surviving at 12 Months | From date of treatment start to date of progression or death, or censored at 12 months, whichever occurred first. | The population evaluable for the 12-month PFS outcome is defined as all subjects who initiate treatment with SBRT and experienced a PFS event within 12 months of enrollment or have at least one year of radiologic follow-up from enrollment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | From date of treatment start to date of progression or death, or censored as described; assessed for approximately 5 years | |||
| SECONDARY | Overall Survival (OS) | From date of treatment start to date of death, or censored as described; assessed for approximately 5 years | |||
| SECONDARY | Radiologic Clinical Complete Response | Approximately 3 months after last treatment of concurrent mediastinal chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) | Defined as all subjects who initiate treatment with SBRT and who have PET/CT results at approximately 3 months after last treatment of concurrent mediastinal chemoradiation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Objective Response | From enrollment to best response while on study treatment; participants remained on study treatment (including SBRT, chemoradiation, and durvalumab) 4.5 months on average. | The response evaluable population is defined as all subjects who initiate treatment with SBRT and who have measurable disease present at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Local Control at 12 and 24 Months | From date of treatment start to date of progression of primary lesion or censored as described; assessed for approximately 2 years.] | |||
| SECONDARY | Regional Control at 12 and 24 Months | From date of treatment start to date of progression of regional lesions or censored as described; assessed for approximately 2 years. | |||
| SECONDARY | Locoregional Control at 12 and 24 Months | From date of treatment start to date of progression of primary or regional lesions or censored as described; assessed for approximately 2 years. | |||
| SECONDARY | Distant Control at 12 and 24 Months | From date of treatment start to date of metastatic progression or censored as described; assessed for approximately 2 years | |||
| SECONDARY | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Score | baseline (pre-SBRT), post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) | The evaluable population is defined as all subjects who initiate treatment with SBRT. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Lung Cancer (EORTC QLQ-LC13) Symptom Scores | baseline (pre-SBRT), post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) | The evaluable population is defined as all subjects who initiate treatment with SBRT. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Total Symptom + Interference Score | baseline (pre-SBRT), post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) | The evaluable population is defined as all subjects who initiate treatment with SBRT. | score on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Grade 2 or Higher Radiation Pneumonitis | From enrollment to 6 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 8 months). | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Grade 3 or Higher Pulmonary Events | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With at Least One Serious Event | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With at Least One Treatment Emergent Adverse Event | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With at Least One Grade 3 or Higher Treatment Emergent Adverse Event | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants Who Discontinued Study Treatment Due to Adverse Events | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months) | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants Who Received Durvalumab | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Participants | COUNT_OF_PARTICIPANTS |
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/NCT03141359/outcomes