Intravenously Administered PROMITIL Combined With Radiotherapy in Patients With Cisplatin-Ineligible Head and Neck Cancer Patients
NCT07920289, Phase 1, Phase 2, Not yet recruiting, Assuta Ashdod Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Intravenously Administered PROMITIL Combined With Radiotherapy in Patients With Cisplatin-Ineligible Head and Neck Cancer Patients | ClinicalTrials.gov |
| NCT number | NCT07920289 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assuta Ashdod Hospital | ClinicalTrials.gov |
| Conditions | Head & Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma | ClinicalTrials.gov |
| Interventions | Addition of Promitil to External Beam Radiotherapy | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Short and Intermediate-Term Safety | Two Years | To evaluate the short- and intermediate-term safety of PROMITIL in combination with EBR in an adult population with locally or regionally advanced head and neck cancer and to clear a safe dose level for phase 3 studies | ClinicalTrials.gov |
| Primary | 2-year event-free survival (EFS) | Two years | To evaluate the 2-year event-free survival (EFS) rate in patients treated with PROMITIL in combination with EBR from the day of the first RT treatment fraction | ClinicalTrials.gov |
| Secondary | Long-Term Safety of PROMITIL | Five Years | To evaluate the long-term safety of PROMITIL in combination with EBR in an adult population with locally or regionally advanced head and neck advanced cancer | ClinicalTrials.gov |
| Secondary | Local-Regional Recurrence-Free Survival (LRFS) | Five Years | To evaluate local-regional recurrence-free survival (LRFS) (in months) from the day of the first RT treatment fraction. | ClinicalTrials.gov |
| Secondary | Distant Metastasis-Free Survival (DMFS) | Sixty Months | To evaluate distant metastasis-free survival (DMFS) (in months) from the day of the first RT treatment fraction. | ClinicalTrials.gov |
| Secondary | Time to Recurrence (TTR) | 60 months | To evaluate time to recurrence (TTR) (in months) from the day of the first RT treatment fraction. | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | Sixty Months | To evaluate overall survival (OS) (in months) from the day of the first RT treatment fraction. | ClinicalTrials.gov |
| Secondary | Overall Response Rate (ORR) | Sixty Months | To evaluate the overall response rate (ORR) to PROMITIL in combination with EBR | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)