S0225 Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00095641
Recruitment Status : Withdrawn (no longer studying this disease site)
First Posted : November 8, 2004
Last Update Posted : November 8, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx Recurrent Squamous Cell Carcinoma of the Oropharynx Drug: capecitabine Procedure: adjuvant therapy Procedure: chemotherapy Phase 2

Detailed Description:


  • Determine 2-year disease-free survival of patients treated with surgical salvage followed by adjuvant low-dose capecitabine for locally recurrent or persistent squamous cell carcinoma of the head and neck .
  • Determine the toxic effects of this drug in these patients.
  • Determine 2-year overall survival of patients treated with this drug.
  • Determine patterns of disease relapse in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine once daily for 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 2 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Not specified


  • Creatinine clearance ≥ 30 mL/min


  • 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


Biologic therapy

  • No concurrent biologic therapy
  • No concurrent filgrastim (G-CSF)


  • 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


  • See Disease Characteristics
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Recovered from prior surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00095641

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: David Schwartz, MD M.D. Anderson Cancer Center

Responsible Party: Southwest Oncology Group Identifier: NCT00095641     History of Changes
Other Study ID Numbers: CDR0000394169
S0225 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2004    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Paranasal Sinus Neoplasms
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Nose Neoplasms
Nose Diseases
Respiratory Tract Diseases
Paranasal Sinus Diseases
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents