NCT00544414 · REGISTRY CONDITION SEARCH

Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2025-02-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response

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outcome · POSTED

Progression-free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 0 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
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
label
Treatment
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment
name
cisplatin
type
DRUG
arm Group Labels
Treatment
name
docetaxel
type
DRUG
arm Group Labels
Treatment
name
fluorouracil
type
DRUG
arm Group Labels
Treatment
name
gemcitabine hydrochloride
type
DRUG
arm Group Labels
Treatment
name
leucovorin calcium
type
DRUG
arm Group Labels
Treatment
name
gene expression analysis
type
GENETIC
arm Group Labels
Treatment
name
protein expression analysis
type
GENETIC
arm Group Labels
Treatment
name
laboratory biomarker analysis
type
OTHER
arm Group Labels
Treatment
name
adjuvant therapy
type
PROCEDURE
arm Group Labels
Treatment
name
biopsy
type
PROCEDURE
arm Group Labels
Treatment
name
conventional surgery
type
PROCEDURE
arm Group Labels
Treatment
name
neoadjuvant therapy
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 31
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial response (PR): Greater than or equal 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline. Overall Response (OR) = CR + PR.
measure
Overall Response
time Frame
30 days after last course of treatment
description
Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 50% increase or an increase of 10 cm\^2 (whichever is smaller) in the sum of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition. Progression-free survival defined as from first day of treatment until the date of first documented progression or date of death from any cause, whichever came first. If failure has not occurred, failure time is censored at the time of last follow-up.
measure
Progression-free Survival
time Frame
From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 171 months

Full study description

brief 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.
detailed Description: OBJECTIVES: Primary * To assess the complete and overall response rate of neoadjuvant docetaxel, cisplatin, fluorouracil, and leucovorin calcium in previously untreated patients with local regionally advanced head and neck cancer. * To evaluate the feasibility of a multimodality treatment approach with the goal of reducing long-term sequelae. * To evaluate prospectively, the impact of neoadjuvant chemotherapy, concurrent chemoradiotherapy, and organ preservation surgery on overall survival, time to progression, and pattern of disease recurrence in these patients. * To evaluate prospectively, biochemical correlates of response and prognosis, including markers such as thymidylate synthetase, ribonucleotide reductase, and ERCC1 (measured by quantitative PCR), p53 (evaluated by IHC), and HPV status and apoptosis (TUNEL assay). Secondary * To evaluate treatment-associated morbidity with the use of a quality of life assessment tool. * To compare the results of diagnostic salivary cytology with those of histopathology at initial diagnosis as well as follow-up in head and neck cancer patients. * To evaluate the tolerability of combined chemoradiotherapy using gemcitabine and cisplatin after definitive surgery for squamous cell carcinoma of the head and neck. OUTLINE: 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 in the absence of disease progression or unacceptable toxicity. 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 in the absence of disease progression or unacceptable toxicity. Patients complete the FACT-H\&N quality of life questionnaire at baseline and at completion of neoadjuvant therapy. Tissue biopsies are collected at baseline, periodically during therapy, at surgery, and after radiotherapy. Tissue is examined for gene and protein expression.

Source references

references

citation
Psyrri 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
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice