Capecitabine + Irinotecan Followed by Combined Modality Capecitabine and Radiation in Locally Advanced Rectal Cancer
Public ClinicalTrials.gov record NCT00216086. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Trial of Preoperative Capecitabine Plus Irinotecan Followed by Combined Modality Capecitabine and Radiation for Locally Advanced Rectal Cancer: Hoosier Oncology Group GI03-53
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Preoperative induction chemotherapy has been successfully used in a variety of malignancies and provides several advantages over postoperative therapy. Combination of 5-FU/Leucovorin/CPT-11 has demonstrated significantly better response rate than 5-FU/Leucovorin alone. Replacing 5-FU with oral capecitabine in combination with CPT-11 has emerged as a potentially more effective, safe and convenient treatment option for metastatic colorectal cancer. Capecitabine is also well tolerated in concurrent treatment with radiation. Recent data has shown that preoperative radiation appears to be significantly more effective in increasing resectability rates. This trial will investigate the activity of capecitabine and CPT-11 combination in the preoperative setting followed by chemoradiation with capecitabine in locally advanced rectal cancer to improve response and decrease local recurrence. We will also study whether TS, TP, DPD and carboxyesterase expressions correlate with the objective response rate with this chemotherapy and chemoradiation regimen.
Study identification
- NCT ID
- NCT00216086
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 22 participants
Conditions and interventions
Conditions
Interventions
- Capecitabine Drug
- Irinotecan Drug
- EUS Procedure
- Neoadjuvant Chemotherapy Drug
- Preoperative Radiation Procedure
- Surgery Procedure
- Adjuvant Chemotherapy Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2005
- Primary completion
- Apr 30, 2008
- Completion
- Apr 30, 2008
- Last update posted
- Jun 5, 2016
2005 – 2008
United States locations
- U.S. sites
- 9
- U.S. states
- 1
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Elkhart Clinic | Elkhart | Indiana | 46515 | — |
| Fort Wayne Oncology & Hematology, Inc | Fort Wayne | Indiana | 46815 | — |
| Center for Cancer Care at Goshen Health System | Goshen | Indiana | 46527 | — |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | — |
| Quality Cancer Center (MCGOP) | Indianapolis | Indiana | 46202 | — |
| Medical Consultants, P.C. | Muncie | Indiana | 47303 | — |
| Center for Cancer Care, Inc., P.C. | New Albany | Indiana | 47150 | — |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46601 | — |
| AP&S Clinic | Terre Haute | Indiana | 47804 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00216086, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 5, 2016 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00216086 live on ClinicalTrials.gov.