Trial · NCT02906800
Potentiation of Cisplatin-based Chemotherapy by Digoxin in Advanced Unresectable Head and Neck Cancer Patients
NCT02906800, Phase 1, Phase 2, Unknown, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Potentiation of Cisplatin-based Chemotherapy by Digoxin in Advanced Unresectable Head and Neck Cancer Patients. Trials, record NCT02906800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02906800
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Potentiation of Cisplatin-based Chemotherapy by Digoxin in Advanced Unresectable Head and Neck Cancer Patients
- NCT number
- NCT02906800
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 15 participants, estimated
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Head and Neck Cancer
- Interventions
- Digoxin
- First posted
- 2016-09-20
- Last updated
- 2017-10-19
- Other registries' IDs
- eudract:2015-003076-78
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Appearance of the grade 3 or 4 (Adverse Events graded by NCI CTC version 4.0) clinical or biological toxicity of the combination of digoxin to cisplatin-based chemotherapy during the study | 18 weeks | |
| Secondary | Clinical response after chemotherapy by fibroscopy (tumor seize) | At 18 weeks | |
| Secondary | Radiological response after chemotherapy | At 18 weeks | Measured by TDM, MRI and TEP-Scan (tumor seize, criteria RECIST (Response Evaluation Criteria In Solid Tumours) |
| Secondary | Biological efficacy: monitored by analysis of T cells recruitment | At 18 weeks | Analysis of the T cells recruitment in biopsies from HNSCC patients after therapy. The T cell recruitment will be considered as significant if T cells increase of at least 25% in post-therapeutic compared to pre-therapeutic biopsies |
| Secondary | Biological efficacy: monitored by analysis of subpopulations of T cells | At 18 weeks | Analysis of subpopulations of T cells (CD8+T cells, regulatory T cells (CD4+CD25+Foxp3+ and gamma-delta T cells) in tumor biopsies by immunofluorescence analysis to show a potential higher ratio of effector/regulatory T cells after therapy as previously described (Badoual C et al Clin Cancer Res 2006). |
| Secondary | Biological efficacy: expression of IFN gamma assessed by quantitative RT-PCR assay | At 18 weeks | |
| Secondary | Biological efficacy: expression of IL-17 assessed by quantitative RT-PCR assay | At 18 weeks | |
| Secondary | Progression Free Survival (PFS): Death or recurrence (clinical and/or radiological analysis) | 10 days after each cycle of chemotherapy and two weeks after the end of the third cycle of chemotherapy | Death or recurrence (clinical and/or radiological analysis) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT02906800
GET https://conductscience.org/api/trials/v1/NCT02906800/registered