TriangleNCT00069121 · CITED IN SOURCE DOCUMENTS
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2020-03-06
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Disease-Free Survival (DFS) [Number of Events]
Relapse-Free Survival (RFS) [Number of Events]
Disease-Free Survival (DFS) [Time to Event]
Relapse-Free Survival (RFS) [Time to Event]
Overall Survival [Number of Events]
Overall Survival [Time to Event]
Number of Participants With at Least One Adverse Event by Most Severe Intensity
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Histologically confirmed colon carcinoma, AJCC/UICC Stage III (Dukes stage C) * Complete tumor resection; Patients operated with curative intent and with no macroscopic or microscopic evidence for remaining tumor who can be randomized to either treatment arm within 8 weeks after surgery. As this is an adjuvant trial patients should never have had any evidence of metastatic disease (including presence of tumor cells in the ascites). * Have a life expectancy of at least 5 years Exclusion Criteria: * Pregnant or lactating women * Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study * Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated colon cancer * Patients who have not completely recovered from surgery
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants were given one of two regimens (each participating center prespecified which regimen they would use for all patients at that center): i) Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; ii) Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks).
- intervention Names
- Drug: Leucovorin (LV)
- Drug: 5-Fluorouracil (5-FU)
- label
- 5-Fluorouracil/Leucovorin (5-FU/LV)
- type
- ACTIVE_COMPARATOR
- description
- Capecitabine was administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks).
- intervention Names
- Drug: Capecitabine
- Drug: Oxaliplatin
- label
- Capecitabine in Combination with Oxaliplatin (XELOX)
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Capecitabine in Combination with Oxaliplatin (XELOX)
- description
- 1000 milligrams per square metre of body surface area (mg/m\^2) orally twice daily on days 1-15 of each 3-week cycle.
- name
- Capecitabine
- other Names
- Xeloda
- type
- DRUG
- arm Group Labels
- Capecitabine in Combination with Oxaliplatin (XELOX)
- description
- 130 mg/m\^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.
- name
- Oxaliplatin
- type
- DRUG
- arm Group Labels
- 5-Fluorouracil/Leucovorin (5-FU/LV)
- description
- Administered by one of two regimens, as specified in the arm description.
- name
- Leucovorin (LV)
- type
- DRUG
- arm Group Labels
- 5-Fluorouracil/Leucovorin (5-FU/LV)
- description
- Administered by one of two regimens, as specified in the arm description.
- name
- 5-Fluorouracil (5-FU)
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1886
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.
- measure
- Disease-Free Survival (DFS) [Number of Events]
- time Frame
- Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
- description
- Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
- measure
- Disease-Free Survival (DFS) [Time to Event]
- time Frame
- Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
- secondary Outcomes
- description
- A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment.
- measure
- Relapse-Free Survival (RFS) [Number of Events]
- time Frame
- Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
- description
- A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
- measure
- Relapse-Free Survival (RFS) [Time to Event]
- time Frame
- Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
- description
- Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
- measure
- Overall Survival [Number of Events]
- time Frame
- Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
- description
- Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
- measure
- Overall Survival [Time to Event]
- time Frame
- Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
- description
- The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details.
- measure
- Number of Participants With at Least One Adverse Event by Most Severe Intensity
- time Frame
- From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).
Full study description
- brief Summary
- 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.
Source references
- references
- citation
- Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.
- pmid
- 36306483
- type
- DERIVED
- citation
- Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107. Epub 2015 Aug 31.
- pmid
- 26324362
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- ents with Stage III colon cancer as a component of a combination chemotherapy regimen was derived from studies in the published literature, including NO16968 [ NCT00069121 ], a multicenter, open-label, randomized trial, where the major efficacy outcome measure was disease free survival. Perioperative Treatment of Rectal Cancer Th
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- 2</span> every 21 days for a total of 8 cycles).[<a href="#cit/section_8.29">29</a>] A randomized phase III trial (<a href="https://clinicaltrials.gov/ct2/show/NCT00069121" title="https://clinicaltrials.gov/ct2/show/NCT00069121">NO16968</a> [NCT00069121]), randomly assigned 1,886 patients with stage III colon cancer to receive CA
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- Updated: February 12, 2025
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- February 12, 2025
Preserved source evidence · Not medical advice