Clinical trial · Interventional
S0225 Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer
S0225: Phase II Study of Adjuvant Low-Dose Capecitabine After Salvage Surgery in Patients With Locally Recurrent or Persistent Squamous Cell Carcinoma of the Head and Neck
NCT00095641CI-TRIAL-00012606withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no longer studying this disease site
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving capecitabine after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who have undergone surgery for locally recurrent or persistenthead and neck cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Squamous Cell Carcinoma of the Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Larynx | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Recurrent Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| capecitabine | Drug | Capecitabine | ALIAS |
| chemotherapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Locoregionally recurrent or persistent disease * No thyroid gland, salivary gland, or nasopharynx disease sites * Must have undergone definitive or post-operative radiotherapy at the time of initial curative treatment * Must have undergone salvage surgical resection within the past 56 days * All current disease must be completely resected, including resection of recurrent primary disease and/or neck dissection, if regional nodal disease is present * Surgical margins must be free of disease on final pathological evaluation of specimens * No definitive or adjuvant radiotherapy or reirradiation for recurrent or persistent disease allowed at the time of salvage treatment * No evidence of distant disease by clinical examination and CT scan of the chest and upper abdomen (including the liver) within the past 90 days 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 Hepatic * Not specified Renal * Creatinine clearance ≥ 30 mL/min Other * Not pregnant or nursing * Fertile patients must use effective contraception * Able to take oral tablets OR able to take crushed tablets through a gastrostomy tube * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biologic therapy * No concurrent filgrastim (G-CSF) Chemotherapy * Prior systemic chemotherapy as definitive therapy for head and neck cancer allowed (prior treatment with fluorouracil allowed, but must be catalogued) * More than 5 years since prior systemic chemotherapy for any other cancer diagnosis * No other concurrent chemotherapy Endocrine therapy * No concurrent anticancer hormonal therapy * Concurrent hormonal therapy for non-cancer diagnosis allowed Radiotherapy * See Disease Characteristics * No concurrent radiotherapy Surgery * See Disease Characteristics * Recovered from prior surgery
References
Publications (0)
Data not yet available
No reference posted for this study.