Trial · NCT03141359
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | 12-month progression free survival was determined for each subject as a binary variable indicating whether or not the subject was progression free and surviving at 12 months after study enrollment. Failure occurred if the subject progressed or died from any cause within 12 months of study enrollment. Disease progression was determined according to RECIST v1.1. |
| 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 | PFS is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death. PD must be objectively determined per RECIST v1.1 criteria, where progression date is date of last radiologic assessment that identified PD. If subject died without documented PD, progression date will be death date. For surviving subjects who do not have PD, PFS will be censored at the date of last radiologic assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS will be censored at the date of last radiologic assessment prior to commencement of subsequent therapy. Subjects who have an initial PFS event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments. |
| Secondary | Overall Survival (OS) | From date of treatment start to date of death, or censored as described; assessed for approximately 5 years | OS is defined as the duration from enrollment to the study (treatment start date) to the date of death from any cause. Participants who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive. |
| 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) | Radiologic clinical complete response will be recorded for each subject as a binary variable indicating whether or not the subject had no evidence of disease on either PET/CT or CT scan approximately 3 months after the last treatment of concurrent mediastinal chemoradiation. |
| 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. | Objective response is determined for each participant as a binary variable indicating whether or not the participant achieved a best overall response of complete response (CR) or partial response (PR) as determined by RECIST v1.1 criteria. |
| 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.] | Local control (LC) is defined as the duration of time from enrollment to the study to first progression of the subject's primary lesions(s). If a participant dies prior to local progression local control will be censored at the date of death. For surviving subjects with no documented local progression, local control will be censored at the date of the last radiologic assessment that evaluated the local tumor(s). For subjects who receive subsequent anticancer therapy prior to documented local progression, local control will be censored at the date of last radiologic assessment that evaluated the local tumor(s) prior to the commencement of subsequent therapy. Local control will be estimated at 12 and 24 months. |
| 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. | Regional control (RC) is defined as the duration of time from enrollment to the study to first progression of the subject's regional lesions(s). If a participant dies prior to regional progression regional control will be censored at the date of death. For surviving subjects with no documented regional progression, regional control will be censored at the date of the last radiologic assessment that evaluated the regional tumor(s). For subjects who receive subsequent anticancer therapy prior to documented regional progression, regional control will be censored at the date of last radiologic assessment that evaluated the regional tumor(s) prior to the commencement of subsequent therapy. Regional control will be estimated at 12 and 24 months. |
| 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. | Locoregional control is defined as the duration of time from enrollment to the study to first progression of the subject's local and/or regional lesions(s), whichever occurs first. If a participant dies prior to locoregional progression locoregional control will be censored at the date of death. For surviving subjects with no documented local and/or regional progression, locoregional control will be censored at the date of the last radiologic assessment that evaluated the local and regional lesion(s). For subjects who receive subsequent anticancer therapy prior to documented locoregional progression, locoregional control will be censored at the date of last radiologic assessment that evaluated the local and regional tumor(s) prior to the commencement of subsequent therapy. Locoregional control will be estimated at 12 and 24 months. |
| 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 | Distant control defined as the duration of time from enrollment to first metastatic progression. If a subject dies prior to metastatic progression, distant control will be censored at the date of death. For surviving subjects with no documented metastatic progression, distant control will be censored at the date of the last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented metastatic progression, distant control will be censored at the date of last radiologic assessment prior to the commencement of subsequent therapy. Distant control will be estimated at 12 and 24 months. |
| 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 EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. EORTC QLQ-C30 includes 5 functional scales, 9 symptom scales/items, and a global health status/quality of life (QoL) scale. The global health status/QoL score is determined from two 7-point items, ranging from 1 (Very Poor) to 7 (Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score represents a higher (better) quality of life. |
| 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 EORTC QLQ-LC13 is a 13-item questionnaire to assess lung cancer associated symptoms, treatment related side effects and pain medication. Both multi-item and single-item measures of lung-cancer associated symptoms and side-effects from conventional chemo and radiotherapy. We focused on 3 symptoms of interest from the EORTC QLQ-LC13: dyspnoea, coughing, and dysphagia. Dyspnoea is a function of three items and can only be determined if all three items have been answered, while coughing and dysphagia are single-item symptoms. Each symptom score is determined by averaging the items that contribute to the scale to get a raw score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher symptom score represents a higher (worse) level of symptoms. |
| 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 MDASI-LC Module includes 22 questions to assess the severity of multiple lung cancer-related symptoms and the impact of these symptoms on daily functioning. Scores for each item range from 0 to 10, where 0 indicates no symptoms and 10 indicates worst possible symptoms. Arithmetic mean of the items completed was calculated to determine a mean total symptom + interference score ranging from 0 to 10. The mean score is reported if more than 50% of the items are completed on a given administration. Higher scores indicate worse symptoms and more interference. |
| Other | 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). | A binary variable will be determined for each subject indicating whether or not the subject experienced at least one grade 2 or higher pneumonitis adverse event according to the NCI Common Terminology for Adverse Events version 4.0 during induction. Pneumonitis events receiving treatment with steroids and possibly, probably, or definitely attributed to SBRT or mediastinal radiation will be included. |
| Other | 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). | A binary variable will be determined for each subject indicating whether or not the subject experienced at least one grade 3 or higher pulmonary adverse event according to the NCI Common Terminology for Adverse Events version 4.0 during induction. This includes pulmonary adverse events regardless of attribution. |
| Other | 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). | A binary variable will be determined for each participant indicating whether or not the subject had at least one adverse event that was categorized as serious, regardless of causality. Serious is defined per the study protocol and includes events that the investigator deems serious and results in the following outcomes: death, life-threatening situation, persistent or significant disability/incapacity, requires or prolongs hospitalization, congenital anomaly/birth defect in the offspring of a study participant, suspected transmission of any infections agent via medical product, or based upon medical judgement, may jeopardize the subject and may require medical or surgical intervention to prevent one of the afore listed outcomes from occurring. |
| Other | 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). | A binary variable will be determined for each participant indicating whether or not the subject had at least one treatment-emergent adverse event, regardless of causality. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 4.0. Treatment-emergent is defined per the study protocol and includes AEs that occur after treatment start that were not present at the time of treatment start or AEs that increase in severity after treatment start if the event was present at the time of treatment start. |
| Other | 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). | A binary variable will be determined for each participant indicating whether or not the subject had at least one grade 3 or higher treatment-emergent adverse event, regardless of causality. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 4.0. Treatment-emergent is defined per the study protocol and includes AEs that occur after treatment start that were not present at the time of treatment start or AEs that increase in severity after treatment start if the event was present at the time of treatment start. |
| Other | 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) | A binary variable will be determined for each participant indicating whether or not the subject discontinued study treatment due to adverse events. |
| Other | 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). | A binary variable will be determined for each participant indicating whether or not the subject received at least one dose of durvalumab on study |
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/registered