NCT00544414CompletedPhase 2
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 · Last updated 19 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 13 Oct 2007
- Start date
- 7 Jun 2000
- Primary completion date
- 14 Feb 2017
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Head and neck cancer, Childhood cancers
- NCT number
- NCT00544414
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 31
- From 7 Jun 2000 to the primary completion date, 14 Feb 2017
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 0 years to 120 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.