CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
capecitabine +1 moredrug
Likely dose
Capecitabine 1000 mg/day orally for one yearAI-extracted
Key inclusion· 7
  • Histologically confirmed squamous cell carcinoma of the head and neck from oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or unknown primary
  • Any disease stage allowed
  • No evidence of active disease
  • Must have undergone curative surgical resection, radiotherapy, and/or chemotherapy at least 1 month, but no more than 4 years ago
Key exclusion· 10
  • Myocardial infarction within the past 12 months
  • Uncontrolled congestive heart failure or unstable/uncontrolled angina
  • Malabsorption syndrome
  • Other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of cervix, or stage I-II cancer in complete remission

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00258310
NCT00258310Phase 2Completed

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

Barbara Ann Karmanos Cancer Institute·interventional·Posted Nov 24, 2005·Updated Mar 10, 2023

In Brief

A Phase 2 clinical trial evaluating capecitabine and Surgery, chemotherapy and/or radiotherapy for Head and Neck Cancer. Completed, enrolled 35 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 24, 2005
Enrollment StartDec 1, 2003
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 20.6 years ago

Interventions

capecitabinedrug

Capecitabine 1000mg/day for one year

Surgery, chemotherapy and/or radiotherapyprocedure

Surgery, chemotherapy and/or radiotherapy