Clinical trial · Interventional
Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer
Multimodality Management of Head and Neck Cancer: A Phase II Trial of Induction Chemotherapy, Organ Preservation Surgery, and Concurrent Chemoradiotherapy
- 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as gemcitabine and cisplatin may make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy before surgery or radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving chemotherapy followed by surgery, chemotherapy, and radiation therapy works in treating patients with locally advanced head and neck cancer.
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 (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| biopsy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients receive neoadjuvant induction chemotherapy comprising docetaxel IV over 1 hour on day 1 and cisplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on days 1-4. Induction chemotherapy repeats every 28 days for 3 courses. Patients with partial response at the primary site may undergo radical or functional resection of the primary tumor within 3 weeks of completion of neoadjuvant therapy. Beginning within 4 weeks of completion of neoadjuvant therapy, patients with persistent disease or complete response after chemotherapy at the primary or neck then undergo radiotherapy 5 days a week for 7 weeks and receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes on day 1 of each week of radiotherapy.
- interventionNames
- Drug: cisplatin
- Drug: docetaxel
- Drug: fluorouracil
- Drug: gemcitabine hydrochloride
- Drug: leucovorin calcium
- Genetic: gene expression analysis
- Genetic: protein expression analysis
- Other: laboratory biomarker analysis
- Procedure: adjuvant therapy
- Procedure: biopsy
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
- Procedure: quality-of-life assessment
- Radiation: radiation therapy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck, including any of the following subtypes: * Oral cavity * Oropharynx * Hypopharynx * Larynx * Stage III or IV disease * Stage II carcinoma of the larynx, hypopharynx, or base of tongue allowed * Measurable disease * Resectable disease, defined as tumors that are potentially curable by surgery and radiotherapy PATIENT CHARACTERISTICS: * Karnofsky performance status ≥ 60% * ANC ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 60 mL/min * Bilirubin ≤ 1.5 mg/dL * Transaminases and alkaline phosphatase meeting 1 of the following criteria: * ALT or AST ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal * Alkaline phosphatase ≤ 4 times ULN AND ALT and AST normal * ALT or AST \< 1.5 times ULN AND alkaline phosphatase \< 2.5 times ULN * Free of serious infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior malignancy allowed for purposes of determining disease-free or overall survival except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years * No unstable angina, history of congestive heart failure, or acute myocardial infarction within the past 6 months * No current symptomatic, neurosensory or neuromotor toxicity ≥ grade 2 * No other significant medical or psychiatric condition incompatible with the protocol PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for head and neck cancer
References
Publications (1)
- DERIVEDPsyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23. PMID 25057165