Clinical trial · Interventional
S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer
Adjuvant 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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual and suspension of head and neck committee
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin and docetaxel works in treating patients with completely resected stage III or stage IV 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 (3)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- chemoRT after surgery
- description
- chemoRT with cisplatin and docetaxel after surgery
- interventionNames
- Drug: cisplatin
- Drug: docetaxel
- Radiation: radiation therapy
Primary outcomes (4)
- measure
- Disease progression
- measure
- Disease-free survival
- measure
- Symptomatic deterioration
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 amifostineReferences
Publications (0)
Data not yet available