Clinical trial · Interventional
Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study
A Phase II Study of Docetaxel/Cisplatin/5-Fluorouracil (TPF) Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Using a Modified Radiation Dose in Patients With Newly Diagnosed HPV Positive, Locally Advanced Squamous Cell Carcinoma of the Oropharynx
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to slow accrual
Summary
Brief summary (as posted)
In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment is effective but has many immediate and long-term side effects. People who have squamous cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human papillomavirus (HPV) have been shown to have a high response to this treatment along with a high cure rate. The investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.
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 |
|---|---|---|---|
| Human Papilloma Virus | — | UNRESOLVED | — |
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| cetuximab | Drug | Cetuximab | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TPF Induction Chemotherapy followed by Chemoradiotherapy
- description
- Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
- interventionNames
- Drug: docetaxel
- Drug: cisplatin
- Drug: 5-FU
- Radiation: IMRT
- Drug: cetuximab
- Drug: carboplatin
Primary outcomes (1)
- measure
- 2-Year Local-Regional Control Rate
- timeFrame
- Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx or unknown primary that is HPV 16 positive as determined by ISH and p16 positive as determined by IHC. * Stage 3 or 4 disease without evidence of distant metastases * At least one evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria * 18 years of age or older * No previous surgery, radiation therapy or chemotherapy for SSCHN is allowed at time of study entry * ECOG Performance Status of 0 or 1 * No active alcohol addiction * Adequate bone marrow, hepatic and renal function as defined in the protocol * Women of child-bearing potential must have a negative pregnancy test within 7 days of starting treatment Exclusion Criteria * Pregnant or breast feeding women or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months after * Previous or current malignancies at other sites * Symptomatic peripheral neuropathy of grade 2 or greater * Symptomatic altered hearing greater than grade 2 * Other serious illnesses or medical conditions * Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry * Concurrent treatment with any other anticancer therapy * Participation in an investigational trial within 30 days of study entry
References
Publications (0)
Data not yet available