Clinical trial · Interventional
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Radiotherapy With Concurrent Chemotherapy (RT/CT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Mucositis | — | UNRESOLVED | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stomatitis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin chemotherapy | Drug | — | UNRESOLVED |
| palifermin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Palifermin
- description
- Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
- interventionNames
- Drug: palifermin
- Drug: cisplatin chemotherapy
- Radiation: Radiotherapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
- interventionNames
- Drug: Placebo
- Drug: cisplatin chemotherapy
- Radiation: Radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx * Newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected disease); American Joint Committee on Cancer \[AJCC\] Stage III, IVA or IVB amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality * At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized * Concurrent chemotherapy regimen of Cisplatin 100mg/m\^2 on days 1, 22, and 43 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2 * Adequate hematologic, renal and hepatic function * Negative pregnancy test by serum or urine * Signed informed consent Key Exclusion Criteria: \- Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for greater than 3 years)
References
Publications (0)
Data not yet available