Clinical trial · Interventional
Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
Concurrent Chemoradiation Versus Induction Docetaxel, Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy in Locally Advanced Hypopharyngeal and Base of Tongue Cancer: A Randomized Phase II Study
NCT01312350CI-TRIAL-00042136completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 investigators will examine whether 2-cycles of DFP chemotherapy before definitive concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally advanced (Stage III \& IVM0) hypopharyngeal and base of tongue carcinoma compared to definitive CCRT alone.
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 |
|---|---|---|---|
| Hypopharyngeal Cancer | Malignant Hypopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant docetaxel/cisplatin/fluorouracil | Drug | — | UNRESOLVED |
| No treatment before definitive CCRT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CCRT only arm
- description
- no neoadjuvant chemotherapy before definitive CCRT
- interventionNames
- Drug: No treatment before definitive CCRT
- type
- EXPERIMENTAL
- label
- neoadjuvant chemotherapy arm
- description
- 2 cycles of TPF chemotherapy before definitive CCRT
- interventionNames
- Drug: neoadjuvant docetaxel/cisplatin/fluorouracil
Primary outcomes (1)
- measure
- To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically/cytologically proven stage III/IVM0 hypopharyngeal or base of tongue cancer * One or more evaluable or measurable lesion * No prior chemotherapy, radiation, or surgery * ECOG 0-2 Exclusion Criteria: * Distant metastasis * Other malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.