Trial · NCT03894891
Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer
NCT03894891, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2023-12-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer. Trials, record NCT03894891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03894891
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer
- NCT number
- NCT03894891
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Head and Neck Cancer
- Interventions
- Nivolumab, Cisplatin, Docetaxel, Intensity-modulated radiotherapy
- First posted
- 2019-03-29
- Last updated
- 2023-12-20
- Results first posted
- 2023-12-20
- Limitations and caveats
- This study terminated early due to weak accrual and therefore no inference is possible.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Laryngectomy-free Survival (LFS) | Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were followed up to 18.9 months. | LFS defined as time from study registration to earlier of surgical removal of larynx and/or hypopharynx, or death due to any cause. Participants alive with intact larynx and hypopharynx are censored at date of last disease evaluation. Given limited sample size and zero events, the Kaplan-Meier method was not used for estimate of LFS. |
| Secondary | Best Radiologic Response | Disease evaluation following the completion of the induction phase of treatment on cycle 3 day 43-63. | Best radiologic response on treatment was evaluated per RECIST 1.1 criteria. For target lesions: complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Non-CR/Non-PD defined as persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. |
| Secondary | Median Censoring Time for Overall Survival (OS) | Participants were observed for OS up to 23.2 months. | Overall Survival (OS) is defined as the time from study entry to death or censored at date last known alive. Given limited sample size and zero events, the Kaplan-Meier method was not used for the estimate of OS. The empirical median is provided which represents median time to date last known alive (all 6 participants were censored). |
| Secondary | Median Laryngo-esophageal Dysfunction-free Survival (LEDFS) | Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were observed for LEDFS up to 18.9 months. | LEDFS is defined as time from study registration to earlier of surgical removal of larynx and/or hypopharynx, non-functioning larynx and/or hypopharynx (inability to swallow, speak, and/or breath on own), or death from any cause. Participants alive with intact and functioning larynx and hypopharynx and esophagus are censored at date of last disease evaluation. Given limited sample size and zero events, the Kaplan-Meier method was not used for estimate of LEDFS. |
| Secondary | EORTC QLQ-C30 Change in Emotional Functional Score From Baseline to Post IMRT+Nivolumab | At baseline and post IMRT+Nivolumab approximately 22 weeks from start of induction treatment. | The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. The emotional functional (EF) scale has 3 items (v3 items 21-24). Scores are standardized to range from 0-100. Higher scores indicate better emotional health. |
| Secondary | Number of Participants With Grade 3-5 Treatment-related Adverse Events | AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. | All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 The number of treated participants experiencing at least one of these adverse events as defined during the time of observation was counted. |
| Secondary | EORTC QLQ-C30 Change in Fatigue Score From Baseline to Post IMRT+Nivolumab | At baseline and post IMRT+Nivolumab approximately 22 weeks from start of induction treatment. | The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. The fatigue scale has 3 items (v3 items 10,12,18). Scores are standardized to range from 0-100. Higher scores indicate more symptomatology. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Laryngectomy-free Survival (LFS) | Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were followed up to 18.9 months. | months | MEDIAN | |
| SECONDARY | Best Radiologic Response | Disease evaluation following the completion of the induction phase of treatment on cycle 3 day 43-63. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Censoring Time for Overall Survival (OS) | Participants were observed for OS up to 23.2 months. | months | MEDIAN | |
| SECONDARY | Median Laryngo-esophageal Dysfunction-free Survival (LEDFS) | Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were observed for LEDFS up to 18.9 months. | months | MEDIAN | |
| SECONDARY | EORTC QLQ-C30 Change in Emotional Functional Score From Baseline to Post IMRT+Nivolumab | At baseline and post IMRT+Nivolumab approximately 22 weeks from start of induction treatment. | The evaluable population represents participants with the QLQ-C30 completed at both assessment times. | units on a scale | MEDIAN |
| SECONDARY | Number of Participants With Grade 3-5 Treatment-related Adverse Events | AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | EORTC QLQ-C30 Change in Fatigue Score From Baseline to Post IMRT+Nivolumab | At baseline and post IMRT+Nivolumab approximately 22 weeks from start of induction treatment. | The evaluable population represents participants with the QLQ-C30 completed at both assessment times. | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Laryngectomy-free Survival (LFS) | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | 11.1 | Full Range 1.8 to 18.9 | months | |
| Best Radiologic Response | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | Complete Response | 3 | Participants | |
| Best Radiologic Response | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | Partial Response | 2 | Participants | |
| Best Radiologic Response | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | Non-CR/Non-PD | 1 | Participants | |
| Median Censoring Time for Overall Survival (OS) | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | 12.9 | Full Range 2.8 to 23.2 | months | |
| Median Laryngo-esophageal Dysfunction-free Survival (LEDFS) | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | 11.1 | Full Range 1.8 to 18.9 | months | |
| EORTC QLQ-C30 Change in Emotional Functional Score From Baseline to Post IMRT+Nivolumab | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | 8.3 | Full Range -16.7 to 25.0 | units on a scale | |
| Number of Participants With Grade 3-5 Treatment-related Adverse Events | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | 3 | Participants | ||
| EORTC QLQ-C30 Change in Fatigue Score From Baseline to Post IMRT+Nivolumab | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | 33.3 | Full Range -33.3 to 66.7 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | 6 | |
| Overall Study | COMPLETED | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | 0 | |
| Overall Study | NOT COMPLETED | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | 6 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 3 | 6 | |
| other | Hearing impaired | Ear and labyrinth disorders | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 1 | 6 | |
| other | Hyperthyroidism | Endocrine disorders | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 1 | 6 | |
| other | Hypothyroidism | Endocrine disorders | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 1 | 6 | |
| other | Eye disorders - Other | Eye disorders | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 1 | 6 | |
| other | Watering eyes | Eye disorders | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 1 | 6 | |
| other | Constipation | Gastrointestinal disorders | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 1 | 6 | |
| other | Diarrhea | Gastrointestinal disorders | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 4 | 6 | |
| other | Dry mouth | Gastrointestinal disorders | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 4 | 6 | |
| other | Dysphagia | Gastrointestinal disorders | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 3 | 6 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 0 | 6 |
| Total, other adverse events | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 6 | 6 |
| Total, serious adverse events | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | 3 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03894891
GET https://conductscience.org/api/trials/v1/NCT03894891/events?page=2