Clinical trial · Interventional
Xeloda (Capecitabine) and External Beam Radiation
A Phase II Study of Preoperative Capecitabine and Concomitant Radiation in Women With Advanced Inflammatory or Non-Inflammatory Breast Cancer
NCT00916578CI-TRIAL-00033997completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to find out if Xeloda® (capecitabine) and radiation therapy can help to control breast cancer that did not respond well to chemotherapy. The safety of this study treatment will also be studied.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation Therapy + Capecitabine
- description
- Capecitabine 825 mg/m2 twice a day. One of the two daily doses of capecitabine should be taken approximately 2 hours before receiving radiotherapy. The first day of Capecitabine is same day that radiotherapy is started, and last day that Capecitabine is given is last day of radiotherapy. Capecitabine administered only on days patient receives radiation therapy. Radiation therapy dose 50-57 Gy to initial clinical target volume (CTV, gross disease + tissue at risk for micrometastatic disease including margin around gross disease and draining regional lymphatics).
- interventionNames
- Radiation: Radiation Therapy
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins.
- timeFrame
- Participants were monitored from 2009 to 2012.
- description
- The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological confirmation of invasive breast cancer 2. No contraindications to receiving a course of radiation treatment (pregnancy, prior radiation to the volume with disease, or systemic disease in which radiation therapy is an absolute contraindication) 3. Patients who have chemo-refractory gross disease in the breast causing symptoms (pain, drainage, duress) OR gross disease in the breast (greater than or equal to T3) and/or lymph node(s) progressive, persistent, or minimally responsive to chemotherapy deemed inoperable or questionable inoperable OR Recurrent gross disease in a previously unirradiated breast or on the chest wall or in the regional lymphatics (core biopsy will not be offered to patients without gross disease in the breast). 4. Are able to swallow and retain oral medication (intact pill) 5. Age over 18 6. Female gender Exclusion Criteria: 1. Have an active or uncontrolled infection 2. Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent 3. Have used an investigational drug within 21 days preceding the first dose of study medication 4. Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin) 5. Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or physical exam 6. Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.