Clinical trial · Interventional
Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
Phase II Pilot Study of TPF (Docetaxel, Cisplatin, and 5-FU) Induction Chemotherapy Followed by Concurrent Cisplatin and Reduced Dose Radiation in Locally Advanced Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low dose radiation treatment was not appropriate for these patients.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.
Conditions
Conditions (1)
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 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy + Low Dose Radiation
- description
- Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
- interventionNames
- Biological: filgrastim
- Biological: pegfilgrastim
- Drug: cisplatin
- Drug: docetaxel
- Drug: fluorouracil
- Procedure: conventional surgery
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Number of Patients With Feeding Tube Dependency
- timeFrame
- at 12 months
- description
- All patients were non-evaluable and study was terminated early. There is no measure of outcome.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed squamous cell carcinoma of the head and neck
* Stage IVA or IVB disease
* Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery
* Measurable or evaluable disease
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min
* Bilirubin normal
* Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:
* AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
* AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* AP ≤ 5 times ULN AND AST or ALT normal
Exclusion Criteria:
* Salivary gland, sinus, or nasopharyngeal primary disease
* Evidence of distant metastatic disease
* Pregnant or nursing
* Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
* Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
* Peripheral neuropathy ≥ grade 2
* Hearing loss ≥ grade 2
* Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs
* Poor nutritional status, in the opinion of the investigator
* Active infection
* Active ischemic heart disease
* Myocardial infarction within the past 6 months
* Prior radiotherapy above the clavicles
* Prior chemotherapy
* Prior surgery to the primary tumor except biopsy
* Concurrent amifostine or other investigational agentsReferences
Publications (0)
Data not yet available