A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
Public ClinicalTrials.gov record NCT00069121. 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.
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Official title
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC Stage III (Dukes Stage C)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.
Study identification
- NCT ID
- NCT00069121
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,886 participants
Conditions and interventions
Conditions
Interventions
- Capecitabine Drug
- Oxaliplatin Drug
- Leucovorin (LV) Drug
- 5-Fluorouracil (5-FU) Drug
Drug
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 18, 2003 (Actual)
- Primary completion
- Apr 21, 2011 (Actual)
- Completion
- Apr 21, 2011 (Actual)
- Last update posted
- Mar 6, 2020
2003 – 2011
United States locations
- U.S. sites
- 48
- U.S. states
- 25
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Cancer Center At Providence Park | Mobile | Alabama | 36608 | — |
| Central Hematology Oncology Medical Group Inc. | Alhambra | California | 91801 | — |
| Comprehensive Blood/Cancer Ctr | Bakersfield | California | 93309 | — |
| Virginia K. Crossen Cancer Center | Fullerton | California | 92835 | — |
| Pacific Shores Medical Group | Long Beach | California | 90813 | — |
| West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center | Northridge | California | 91325 | — |
| Ventura County Hematology-Oncology Specialists | Oxnard | California | 93030 | — |
| Wilshire Oncology Medical Group | Pomona | California | 91767 | — |
| Sutter Cancer Center | Sacramento | California | 95816 | — |
| Scripps Cancer Center | San Diego | California | 92121 | — |
| Kaiser Permanente San Diego; Hepatology Research | San Diego | California | 92154 | — |
| Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara | California | 93105 | — |
| San Diego Cancer Center'S Medical Group | Vista | California | 92083 | — |
| Innovative clinical research institute/American institute of research | Whittier | California | 90603 | — |
| University of Colorado Health Science Center; Biomedical Research Bldg. Room 511 | Aurora | Colorado | 80045 | — |
| Hematology Oncology Associates | Fort Collins | Colorado | 80528 | — |
| Hematology Oncology P.C. | Stamford | Connecticut | 06902 | — |
| Georgetown Uni Medical Center; Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007 | — |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33804-1057 | — |
| Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Georgia Cancer Specialists | Atlanta | Georgia | 30341 | — |
| Illinois Cancer Care | Peoria | Illinois | 61615 | — |
| Hope Center | Terre Haute | Indiana | 47802 | — |
| Ochsner Cancer Inst. | New Orleans | Louisiana | 70121 | — |
| Park Nicollet Clinic Cancer Center | Saint Louis Park | Minnesota | 55416 | — |
| St Joseph Oncology | Saint Joseph | Missouri | 64507 | — |
| Hematology Oncology Consultants, Inc. | St Louis | Missouri | 63136 | — |
| Hematology-Oncology Centers of the Northern Rockies | Billings | Montana | 59101 | — |
| Great Falls Clinic | Great Falls | Montana | 59405 | — |
| Va Medical Center | Reno | Nevada | 89502 | — |
| Nh Oncology Hematology, Pa | Hooksett | New Hampshire | 03106 | — |
| Morristown Medical Center;Hematology-Oncology Assoc | Morristown | New Jersey | 07962 | — |
| Overlook Oncology Center; Summit Medical Group | Summit | New Jersey | 07901 | — |
| New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico | 87109 | — |
| St. Vincent'S Hospital; Comprehensive Care Center | New York | New York | 10011 | — |
| Presbyterian Healthcare; Cancer Research Dept | Charlotte | North Carolina | 28233-3549 | — |
| Moses Cone Reg Cancer Ctr | Greensboro | North Carolina | 27403 | — |
| Carolina Oncology Specialists, PA - Hickory | Hickory | North Carolina | 28602 | — |
| Oncology-Hematology of Lehigh Valley, Pc | Bethlehem | Pennsylvania | 18015 | — |
| Medical Oncology Associates | Kingston | Pennsylvania | 18704 | — |
| Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology | Philadelphia | Pennsylvania | 19104-4283 | — |
| Fox Chase-Temple Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Uni of Pittsburgh Cancer Inst. ; Oncology | Pittsburgh | Pennsylvania | 15232 | — |
| West Clinic | Germantown | Tennessee | 38138 | — |
| US Oncology | The Woodlands | Texas | 77380 | — |
| Intermountain Hematology & Oncology | Salt Lake City | Utah | 84106 | — |
| Internal Medicine Associates of Yakima Inc. | Yakima | Washington | 98902 | — |
| UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 184 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00069121, 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 Mar 6, 2020 · Synced Nov 11, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00069121 live on ClinicalTrials.gov.