Suspended

S0217Adjuvant Chemo-RT With Cisplatin (NSC-119875) and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

cisplatin

+ docetaxel

+ radiation therapy

DrugRadiation
Who is being recruted

Head and Neck Neoplasms

+ Neoplasms

+ Neoplasms by Site

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2005
See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2005

Actual date on which the first participant was enrolled.

OBJECTIVES: * Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin. * Determine the toxicity of this regimen in these patients. * Categorize the site(s) of disease relapse in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 17.5-23.5 months.

Official TitleAdjuvant Chemo-RT With Cisplatin (NSC-119875) and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN) 
NCT00084435
Principal SponsorSWOG Cancer Research Network
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Head and Neck NeoplasmsNeoplasmsNeoplasms by Site

Criteria

DISEASE CHARACTERISTICS: * Diagnosis of squamous cell carcinoma of the head and neck * Selected stage III or IV (no distant metastasis) disease * The following TNM stages are excluded: * T3, N0, M0 * T4a, N0, M0 * T4b, N3, M0 * Any T, any N, M1 * Complete total resection within the past 56 days AND has one or more of the following risk factors: * Multiple pathologically confirmed lymph node metastases * One or more lymph nodes with extracapsular extension of tumor * Microscopically positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection * No primary nasopharyngeal carcinoma PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT or SGPT ≤ 1.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 mg/dL OR * Creatinine clearance ≥ 60 mL/min Other * No pre-existing peripheral neuropathy * No known history of severe hypersensitiviy reaction to products containing Polysorbate 80 * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for the malignancy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for the malignancy Surgery * See Disease Characteristics Other * No concurrent amifostine

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
chemoRT with cisplatin and docetaxel after surgery

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 29 locations

Suspended

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, United StatesSee the location
Suspended

Decatur Memorial Hospital Cancer Care Institute

Decatur, United States
Suspended

Regional Cancer Center at Memorial Medical Center

Springfield, United States
Suspended

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, United States
Suspended29 Study Centers