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Colorectal CancerPhase 3NCT00009737

A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer

A Phase 3 study testing 5-Fluorouracil, Leucovorin and Capecitabine [Xeloda] in people with Colorectal Cancer, run by Hoffmann-La Roche at 133 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
5-Fluorouracil, Leucovorin and Capecitabine [Xeloda]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,987 participants
Where
133 sitesin 14 countries
Study dates
Nov 1998to Apr 2004
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients 18-75 years of age;
  • histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.

Who cannot join

  • previous chemotherapy

Trial locations and contacts

133 sites in 14 countries.

133 sites in 14 countries

Italy21 sites

  • Study site

    Aviano, 33081

  • Study site

    Bergamo, 24128

  • Study site

    Bologna, 40138

  • Study site

    Cuneo, 12100

  • Study site

    Genova, 16132

  • Study site

    Livorno, 57100

  • Study site

    Mantua, 46100

  • Study site

    Milan, 20121

  • Study site

    Mirano, 30035

  • Study site

    Modena, 41100

  • Study site

    Naples, 80131

  • Study site

    Pisa, 56100

  • Study site

    Roma, 00135

  • Study site

    Roma, 00168

  • Study site

    Roma

  • Study site

    Terni, 05100

  • Study site

    Torino, 10123

  • Study site

    Torino, 10126

  • Study site

    Vecchiazzano, 47100

  • Study site

    Venezia, 30122

  • Study site

    Vicenza, 36100

Other trials in Italy

United States17 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Austin, Texas, 78705

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Buffalo, New York, 14263

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbia, Missouri, 65203

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Hartford, Connecticut, 06102-5037

  • Study site

    Los Angeles, California, 90089

  • Study site

    Miami, Florida, 33176

  • Study site

    Nashville, Tennessee, 37203-1632

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Phoenix, Arizona, 85012

  • Study site

    Seattle, Washington, 98195

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Tyler, Texas, 75701

Other trials in United States

Germany17 sites

  • Study site

    Berlin, 13353

  • Study site

    Braunschweig, 38100

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Göttingen, 37073

  • Study site

    Grenzach-Wyhlen, 79639

  • Study site

    Halle, 06108

  • Study site

    Hanover, 30171

  • Study site

    Kassel, 34125

  • Study site

    Lehrte, 31275

  • Study site

    Magdeburg, 39130

  • Study site

    München, 81245

  • Study site

    Oldenburg, 26121

  • Study site

    Oldenburg, 26133

  • Study site

    Ravensburg, 88212

  • Study site

    Regensburg, 93053

  • Study site

    Villingen-Schwenningen, 78052

  • Study site

    Wuppertal, 42210

Other trials in Germany

United Kingdom15 sites

  • Study site

    Aberdeen, AB25 2ZN

  • Study site

    Belfast, BT9 7AB

  • Study site

    Cardiff, CF14 2TL

  • Study site

    Edinburgh, EH4 2XU

  • Study site

    Glasgow, G12 0YN

  • Study site

    Glasgow, G4 OSF

  • Study site

    Guildford, GU2 7XX

  • Study site

    Leicester, LE1 5WW

  • Study site

    Luton, LU4 0DZ

  • Study site

    Manchester, M20 4BX

  • Study site

    Newcastle upon Tyne, NE4 6BE

  • Study site

    Northwood, HA6 2RN

  • Study site

    Plymouth, PL6 8DH

  • Study site

    Salisbury, SP2 8BJ

  • Study site

    Southampton, SO9 4PE

Other trials in United Kingdom

Australia12 sites

  • Study site

    Adelaide, 5011

  • Study site

    Bendigo, 3550

  • Study site

    Brisbane, 4006

  • Study site

    Fitzroy, 3065

  • Study site

    Kurralta Park, 5037

  • Study site

    Melbourne, 3128

  • Study site

    Melbourne, 3181

  • Study site

    Perth, 6000

  • Study site

    Port Macquarie, 2444

  • Study site

    St Leonards, 2065

  • Study site

    Sydney, 2217

  • Study site

    Wodonga, 3690

Other trials in Australia

Spain12 sites

  • Study site

    Bilbao, 48013

  • Study site

    Córdoba, 14004

  • Study site

    El Palmar Murcia, 30120

  • Study site

    Elche, 03203

  • Study site

    Jaén, 23007

  • Study site

    Madrid, 28006

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28040

  • Study site

    Madrid, 28222

  • Study site

    Navarra, 31008

  • Study site

    Palma de Mallorca, 07014

  • Study site

    Valencia, 46010

Other trials in Spain

Austria11 sites

  • Study site

    Hall in Tirol, 6060

  • Study site

    Innsbruck, 6020

  • Study site

    Klagenfurt, 9026

  • Study site

    Linz, 4010

  • Study site

    Oberwart, 7400

  • Study site

    Sankt Pölten, 3100

  • Study site

    Vienna, 1030

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1100

  • Study site

    Vienna, 1160

  • Study site

    Vienna, 1220

Other trials in Austria

Canada6 sites

  • Study site

    Calgary, Alberta, T2N 4N2

  • Study site

    Kelowna, British Columbia, V1Y 5L3

  • Study site

    Montreal, Quebec, H3G 1A4

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Saskatoon, Saskatchewan, S7N 4H4

  • Study site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Switzerland6 sites

  • Study site

    Basel, 4031

  • Study site

    Basel, 4070

  • Study site

    Bellinzona, 6500

  • Study site

    Bern, 3010

  • Study site

    Sankt Gallen, 9006

  • Study site

    Zurich, 8091

Other trials in Switzerland

Israel5 sites

  • Study site

    Haifa, 34354

  • Study site

    Petah Tikva, 49100

  • Study site

    Petah Tikva

  • Study site

    Rehovot, 76100

  • Study site

    Tel Aviv, 6423906

Other trials in Israel

Argentina4 sites

  • Study site

    Buenos Aires, 1417

  • Study site

    Buenos Aires, 1425

  • Study site

    Buenos Aires, C1264AAA

  • Study site

    Buenos Aires, C1270AAE

Other trials in Argentina

Brazil4 sites

  • Study site

    Porto Alegre, 90020-090

  • Study site

    Rio de Janeiro, 20220-410

  • Study site

    São Paulo, 01406100

  • Study site

    Sorocaba, 18035-300

Other trials in Brazil

Portugal2 sites

  • Study site

    Lisbon, 1649-035

  • Study site

    Porto, 4200-072

Other trials in Portugal

Belgium1 site

  • Study site

    Brussels, 1090

Other trials in Belgium

About this study

Official title: An Open-Label Randomized Phase III Study Comparing Xeloda (Capecitabine) With IV Bolus 5-Fluorouracil in Combination With Low-Dose Leucovorin as Adjuvant Chemotherapy in Patients Who Underwent Surgery for Dukes C Colon Cancer

This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Being tested
5-Fluorouracil, Leucovorin, Capecitabine [Xeloda]
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-FluorouracilDrug

    425mg/m2 iv daily from day 1 to day 5 every 28 days.

  • LeucovorinDrug

    20mg/m2 iv daily from day 1 to day 5 every 28 days.

  • Capecitabine [Xeloda]Drug

    1250mg/m2 po bid on days 1-14 every 21 days.

Study groups in NCT00009737
Study groupRoleWhat they receive
CapecitabineExperimentalParticipants received capecitabine 1250 milligram per square meter (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
Receives: Drug: Capecitabine [Xeloda]
5-Fluorouracil + LeucovorinActive comparatorParticipants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
Receives: Drug: 5-Fluorouracil; Drug: Leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival

    Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).

    Measured: Approximately 3 years

Secondary outcomes (5)

  1. Relapse-Free Survival

    Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.

    Measured: Approximately 3 years

  2. Overall Survival

    Participants with overall survival were reported. Overall survival was assessed as the number of days between randomization and death or the last time at which a participant was known to be alive (censoring time).

    Measured: Approximately 3 years

  3. Mean Change From Baseline in Global Health Status at Week 25

    Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.

    Measured: Baseline (Days -7 to 1) and at Week 25

  4. Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters

    Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.

    Measured: Up to Week 25

  5. Number of Participants With Any Adverse Events and Serious Adverse Events

    An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.

    Measured: Up to Week 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2004 (estimated)
  2. Study startNov 1998
  3. Primary completionApr 2004
  4. Study completionApr 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,987 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00009737
Sponsor's protocol ID
M66001
Status last verified
May 2016
First submitted
2 Feb 2001
Last updated
22 Jun 2016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-Fluorouracil, Leucovorin and Capecitabine [Xeloda] in people with Colorectal Cancer, run by Hoffmann-La Roche at 133 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in Italy, United States, Germany, United Kingdom, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (time frame: Approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00009737.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.

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