Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity
Trial · NCT01265849
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months. | Intent to Treat Population | months | MEDIAN |
| PRIMARY | OS in Low Risk Subjects | From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months. | Low Risk Intent to Treat Population | months | MEDIAN |
| SECONDARY | Local Regional Control (LRC) | From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months. | Intent to treat population | months | MEDIAN |
| SECONDARY | LRC in Low Risk Subjects | From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months. | Low Risk Intent to Treat Population | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months. | Intent to Treat Population | months | MEDIAN |
| SECONDARY | PFS in Low Risk Subjects | From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months. | Low Risk Intent to treat population | months | MEDIAN |
| SECONDARY | Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 2 | Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 2 | Overall number of participants analyzed is the total number of subjects in the longitudinal model.~The number of participants analyzed is the number of subjects assessed at each visit.~This study is not powered for quality of life comparisons. | units on a scale (0-100) | LEAST_SQUARES_MEAN |
| SECONDARY | Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 36 | Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 36 | Overall number of participants analyzed is the total number of subjects with data at this visit.~The number of participants analyzed is the number of subjects assessed at each visit.~This study is not powered for quality of life comparisons. | units on a scale (0-100) | LEAST_SQUARES_MEAN |
| SECONDARY | EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 2 | Baseline [pre-randomization], Long Term Follow-up Month 2 | Overall number of participants analyzed is the total number of subjects in data at that visit.~The number of participants analyzed is the number of subjects assessed at each visit.~This study is not powered for quality of life comparisons. | units on a scale (0-100) | LEAST_SQUARES_MEAN |
| SECONDARY | EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 36 | Baseline [pre-randomization], Long Term Follow-up Month 36 | Overall number of participants analyzed is the total number of subjects with data at this visit.~The number of participants analyzed is the number of subjects assessed at each visit.~This study is not powered for quality of life comparisons. | units on a scale (0-100) | LEAST_SQUARES_MEAN |
| SECONDARY | Statistical Comparisons of Time-to-event Outcomes (OS, LRC, PFS) Were Repeated for Varying Levels of Histopathology (HP) Markers in Low Risk Subjects | From the date of treatment assignment to event (LRC,PFS,OS) or the last follow-up date. Maximum follow-up was approximately 113 months. | The analysis population is the Low Risk Intent to treat Population who had HP marker levels assessed and were in either treatment arm LI + CIZ + SOC or SOC. This includes 82 subjects in LI + CIZ + SOC and 95 subjects in standard of care (SOC). No statistical comparisons were made for the 33 Low Risk subjects with HP markers in treatment arm LI + SOC. No data were collected for this Outcome Measure for treatment arm LI + SOC.. | N of Statistically Significant Results | NUMBER |
| POST_HOC | Tumor Response by RECIST 1.0 | From treatment assignment to planned surgery, 29-38 days for LI treated groups and as soon as practicable with within 8 - 38 days for the SOC group (median 33 days). | Intent to Treat Population | participants | NUMBER |
| POST_HOC | Tumor Response by RECIST 1.0 in Low Risk Subjects | From treatment assignment to planned surgery, 29-38 days for LI treated groups and as soon as practicable with within 8 - 38 days for the SOC group (median 33 days). | Low Risk Intent to Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Survival by Objective Response (CR+PR) | Objective Response: from treatment assignment to surgery: 29-38 days for LI-treated & 8-38 days for SOC (median 33 days). Survival from treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months. | Intent to Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Survival by Objective Response (CR+PR) in Low Risk Subjects | Objective Response: from treatment assignment to surgery: 29-38 days for LI-treated & 8-38 days for SOC (median 33 days). Survival from treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months. | Low Risk Intent to Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Overall Survival by Objective Response (CR+PR) in Low Risk Subjects | Objective Response: from treatment assignment to surgery: 29-38 days for LI-treated & 8-38 days for SOC (median 33 days). Survival from treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months. | Low risk Intent to Treat Population | 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.
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GET https://conductscience.org/api/trials/v1/NCT01265849/outcomes