Ph II Study Examining Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation &/or Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00258310|
Recruitment Status : Completed
First Posted : November 24, 2005
Results First Posted : January 19, 2015
Last Update Posted : January 19, 2015
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who have undergone previous surgery, radiation therapy, and/or chemotherapy for head and neck cancer.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: capecitabine Procedure: Surgery, chemotherapy and/or radiotherapy||Phase 2|
- Determine the feasibility of adjuvant low-dose capecitabine in patients with squamous cell carcinoma of the head and neck who have undergone prior curative surgery, radiotherapy, and/or chemotherapy.
- Determine the time to recurrence, local-regional control, and survival rate in patients treated with this drug.
- Determine the incidence of second primary tumors in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral capecitabine once daily for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Examining the Feasibility of Long Term and Low Dose Oral Capecitabine (Xeloda®) in Newly Diagnosed Head and Neck Squamous Cell Carcinoma (HNSCC) After Surgery, Radiation and/or Chemotherapy|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year.
Capecitabine 1000mg/day for one year
Other Name: Xeloda
Procedure: Surgery, chemotherapy and/or radiotherapy
Surgery, chemotherapy and/or radiotherapy
- Feasibility of Treatment as Assessed. [ Time Frame: within 365 days ]Compliance was taking at least 80% of the prescribed dose for one year.
- Time to Recurrence [ Time Frame: assessed from time of study entry until documented ]
- Local-regional Control Rate Occurrence [ Time Frame: within 365 days ]
- Survival Rate [ Time Frame: from time of study entry until death ]
- Incidence of Second Primary Tumor Occurrence [ Time Frame: Every 12 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00258310
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||George H. Yoo, MD||Barbara Ann Karmanos Cancer Institute|