Clinical trial · Interventional
Chemo-embolization for Head and Neck Cancer
NCT04595981CI-TRIAL-00088949withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No staff or funding to do the study.
Summary
Brief summary (as posted)
The study will evaluate whether adjuvant chemo-embolization increases progression free and/or overall survival relative to standard of care radiation and chemo- and/or immunotherapy in cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SCCHN | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemo-embolization
- description
- Intra-arterial Cisplatin suspension 150-300 mg is infused into the tumor pedicle(s)
- interventionNames
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Evaluate progression free survival
- timeFrame
- 6 Months
- description
- Progression free survival is the length of time from the day of the chemo-embolization procedure that a patient lives with the disease but it does not get worse. Cumulative progression-free survival for all patients will be calculated by the Kaplan-Meier method, including the point estimates of progression-free survival and the 95% confidence intervals, evaluated during a six-month period of follow-up.
Secondary outcomes (2)
- measure
- Evaluate overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Provision of signed and dated informed consent form * 2.Stated willingness to comply with all study procedures and availability for the duration of the study * 3.Male or female, aged 18 or older * 4.Diagnosed with squamous cell carcinoma of the Head and Neck * 5.Ability to undergo chemo-embolization * 6.For females of reproductive potential: Negative pregnancy test at time of chemo-embolization * 7.Platinum-ineligible as determined by presence of CTS grade I nephropathy, neuropathy or otopathy, and/or ECOG 2+ performance status. * 8.Plan to undergo standard of care radiation and chemo- and/or immunotherapy. Exclusion Criteria: * 1\. Medically unfit to undergo chemo-embolization * 2\. Treatment with a competing investigational drug or intervention trial that does not allow adjuvant chemo-embolization.
References
Publications (0)
Data not yet available
No reference posted for this study.