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AzTrials

Colorectal CancerPhase 3NCT00749450

Combination Chemotherapy After Surgery in Treating Patients With High-Risk Stage II or Stage III Colorectal Cancer

A Phase 3 study testing capecitabine, fluorouracil and oxaliplatin in people with Colorectal Cancer, run by Cancer Research UK, Glasgow at 1 site in United Kingdom.

Completed

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Colorectal Cancer
What is being tested?
capecitabine, fluorouracil and oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,088 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2008to Nov 2017
Phase
Phase 3
Are there results?
None posted in the registry

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 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of colorectal cancer meeting 1 of the following criteria:
  • High-risk stage IIB disease, defined as T4 disease, perforation, obstruction, < 10 nodes examined, poorly differentiated histology, extramural venous invasion, or extramural lymphatic invasion
  • Fully resected stage III disease
  • Patients with rectal cancer must meet the following criteria:
  • Underwent prior total mesorectal excision surgery with negative resection (R0) margins
  • No prior pre-operative or scheduled post-operative combined chemotherapy and radiotherapy
  • No evidence of residual or metastatic disease
  • Deemed suitable for adjuvant chemotherapy

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Life expectancy > 5 years with reference to noncancer-related diseases
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Carcinoembryonic antigen (CEA) levels normal
  • Glomerular filtration rate ≥ 30 mL/min (no moderate or severe renal impairment)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must effective contraception
  • More than 12 months since prior and no active clinically significant cardiovascular disease, including any of the following:
  • Cerebrovascular accident
  • Myocardial infarction
  • Unstable angina
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)
  • Disease-free interval of ≥ 5 years for previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal cell or squamous cell carcinoma of the skin
  • No known or suspected dihydropyrimidine dehydrogenase deficiency

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 10 weeks since prior surgery and recovered
  • No prior chemotherapy (except in patients randomized after 12 weeks of adjuvant therapy)
  • No prior abdomino-pelvic radiotherapy, with the exception of short-course pre-operative radiotherapy for rectal cancer
  • No concurrent brivudine or sorivudine for patients taking capecitabine

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 0YN

Other trials in United Kingdom

About this study

Official title: Short Course Oncology Therapy - A Study of Adjuvant Chemotherapy in Colorectal Cancer

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have undergone surgery for high-risk colorectal cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy given after surgery in treating patients with high-risk stage II or stage III colorectal cancer.

Read the detailed description

OBJECTIVES:

  • To assess the efficacy and compare the associated toxicity of adjuvant chemotherapy lasting 12 weeks vs 24 weeks in patients with fully resected high-risk stage II or III colorectal cancer.
  • To conduct an economic analysis of the cost effectiveness of these regimens.
  • To compare the randomization methodologies used in this study.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center's recruitment potential. Patients are randomized (within 10 weeks after surgery and before or after receiving 12 weeks of chemotherapy) to 1 of 2 treatment arms. The treatment regimen that a patient receives (Oxaliplatin Modified DeGramont [OxMdG] or XELOX) is determined by the participating center.

  • Arm I: Patients receive 12 courses of OxMdG (described below) or XELOX (described below)combination chemotherapy (6 additional courses if patient already received 6 courses) for treatment lasting a total of 24 weeks.
  • Arm II: Patients receive 6 courses of OxMdG or XELOX combination chemotherapy (no additional courses if patient already received 6 courses) for treatment lasting a total of 12 weeks.

The two adjuvant combination chemotherapy regimens are administered as follows:

  • OxMdG: Patients receive oxaliplatin IV over 2 hours and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • XELOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life assessments periodically using the EORTC QLQ-C30, EORTC QLQ-CR29, EQ-5D, and GOG Ntx4 questionnaires.

After completion of study treatment, patients are followed periodically for up to 7 years.

Peer Reviewed and Funded by Medical Research Council (MRC)

Keywords
stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

Study groups in NCT00749450
Study groupRoleWhat they receive
Arm IExperimentalPatients receive OxMdG or XELOX combination chemotherapy for a total of 12 courses for treatment lasting a total of 24 weeks.
Receives: Drug: capecitabine; Drug: fluorouracil; Drug: oxaliplatin
Arm IIExperimentalPatients receive OxMdG or XELOX combination chemotherapy for a total of 6 courses for treatment lasting a total of 12 weeks.
Receives: Drug: capecitabine; Drug: fluorouracil; Drug: oxaliplatin

What is being measured

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

  1. 3-year disease-free survival

    Measured: 3 years

Secondary outcomes (4)

  1. Overall survival

    Measured: assessed during 5 year recruitment period and maximum 7 year follow up period

  2. Cost-effectiveness

    Measured: assessed during 5 year recruitment period

  3. Toxicity according to NCI CTCAE Version 3.0

    Measured: assessed during 5 year recruitment period

  4. Quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-CR29, EQ-5D, and GOG Ntx4

    Measured: assessed during 5 year recruitment period

Timeline

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

  1. First posted9 Sep 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionNov 2017

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
6,088 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00749450
Sponsor's protocol ID
CDR0000613042
Other IDs
CRUK-SCOT, ISRCTN59757862, EudraCT 2007-003957-10, EU-20874, SCOT-2007-01
Status last verified
Jul 2018
First submitted
6 Sep 2008
Last updated
27 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36306483

  • Iveson TJ, Sobrero AF, Yoshino T, Souglakos I, Ou FS, Meyers JP, Shi Q, Grothey A, Saunders MP, Labianca R, Yamanaka T, Boukovinas I, Hollander NH, Galli F, Yamazaki K, Georgoulias V, Kerr R, Oki E, Lonardi S, Harkin A, Rosati G, Paul J. Duration of Adjuvant Doublet Chemotherapy (3 or 6 months) in Patients With High-Risk Stage II Colorectal Cancer. J Clin Oncol. 2021 Feb 20;39(6):631-641. doi: 10.1200/JCO.20.01330. Epub 2021 Jan 13.

    PubMed 33439695

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing capecitabine, fluorouracil and oxaliplatin in people with Colorectal Cancer, run by Cancer Research UK, Glasgow at 1 site in United Kingdom.

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

Who may be eligible to take part?

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 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

3-year disease-free survival (time frame: 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 NCT00749450, which also lists 2 linked publications.

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 27 Jul 2018.

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