Phase 2
N=31
Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00544414 ↗Enrolled (actual)
31
Serious AEs
29.0%
Results posted
Apr 2023
Primary outcome: Primary: Overall Response — 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); docetaxel (Drug); fluorouracil (Drug); gemcitabine hydrochloride (Drug); leucovorin calcium (Drug); gene expression analysis (Genetic); protein expression analysis (Genetic); laboratory biomarker analysis (Other); adjuvant therapy (Procedure); biopsy (Procedure); conventional surgery (Procedure); neoadjuvant therapy (Procedure); quality-of-life assessment (Procedure); radiation therapy (Radiation)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- City of Hope Medical Center
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response |
28 | — |
| PRIMARY Progression-free Survival |
170.5 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00544414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.