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Colorectal CancerPhase 3NCT00660894

Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery

A Phase 3 study testing folinate calcium, tegafur-uracil and tegafur-gimeracil-oteracil potassium in people with Colorectal Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

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 tegafur-uracil, leucovorin, and S-1, 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 20 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
folinate calcium, tegafur-uracil and tegafur-gimeracil-oteracil potassium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,535 participants
Where
1 siteJapan
Study dates
Apr 2008to Jul 2015
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of colon
  • Stage III (T1-4, N1-3, M0) disease
  • Has undergone surgical resection of the tumor within the past 8 weeks

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Able to take medications orally
  • WBC ≥ 3,500/mm³ and < 12,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 2.0 mg/dL
  • AST/ALT ≤ 100 IU/L
  • Creatinine ≤ 1.2 mg/dL
  • No other active malignancies
  • Must have none of the following comorbidities:
  • Severe postoperative complications
  • Uncontrollable diabetes mellitus
  • Uncontrollable hypertension
  • Myocardial infraction within 6 months
  • Unstable angina pectoris
  • Hepatocirrhosis
  • Interstitial pneumonia, pulmonary fibrosis, or severe emphysema

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for colon cancer
  • No concurrent radiotherapy
  • No concurrent biological response modifiers

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Tokyo Medical and Dental University

    Tokyo, Tokyo, 113-8519

Other trials in Japan

About this study

Official title: Randomized Phase III Study of UFT+Leucovorin vs. TS-1 as Adjuvant Treatment for Stage III Colon Cancer , and Investigate Predictive Factors Based on Gene Expression

RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, 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 whether giving tegafur-uracil together with leucovorin is more effective than giving S-1 in treating patients with stage III colon cancer.

PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with leucovorin to see how well it works compared with giving S-1 in treating patients with stage III colon cancer that has been completely removed by surgery.

Read the detailed description

OBJECTIVES:

  • Compare the disease-free survival of patients with stage III colon cancer treated with S-1 or tegafur-uracil and leucovorin after curative surgery .

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral tegafur-uracil and oral leucovorin 3 times daily on days 1-21. The treatment repeats 5 times every 5 weeks.
  • Arm II: Patients receive oral S-1 twice daily on days 1-28. The treatment repeats 4 times every 6 weeks.

Biological samples are collected for gene expression analysis for identification of predictive markers.

Being tested
folinate calcium, tegafur-uracil, tegafur-gimeracil-oteracil potassium
Keywords
adenocarcinoma of the colon, stage III colon cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms

What participants receive

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

  • folinate calciumDrug

    Also called Leucovorin, leucovorin

  • tegafur-uracilDrug

    Also called UFT

  • tegafur-gimeracil-oteracil potassiumDrug

    Also called S-1, TS-1

Study groups in NCT00660894
Study groupRoleWhat they receive
tegafur-gimeracil-oteracil potassiumExperimentalPatients receive tegafur-gimeracil-oteracil potassium(S-1) orally twice daily for 28 days with a subsequent pause of 14 days. This repeats 4 times every 6 weeks.
Receives: Drug: tegafur-gimeracil-oteracil potassium
tegafur-uracil and folinate calciumActive comparatorPatients receive tegafur-uracil(UFT) plus folinate calcium(leucovorin) orally every 8 hours for 21 days with a subsequent pause of 7 days. This repeats 5 times every 5 weeks.
Receives: Drug: folinate calcium; Drug: tegafur-uracil

What is being measured

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

  1. Disease-free survival

Secondary outcomes (4)

  1. Overall survival

  2. Adverse event

  3. Pharmaco-economics

  4. Identification of predictive markers

Timeline

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

  1. First posted17 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJun 2012
  4. Study completionJul 2015

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
1,535 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00660894
Sponsor's protocol ID
CDR0000593164
Other IDs
TMDU-TRICC0706
Status last verified
Aug 2016
First submitted
16 Apr 2008
Last updated
3 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • Kusumoto T, Ishiguro M, Nakatani E, Yoshida M, Inoue T, Nakamoto Y, Shiomi A, Takagane A, Sunami E, Shinozaki H, Takii Y, Maeda A, Ojima H, Hashida H, Mukaiya M, Yokoyama T, Nakamura M, Munemoto Y, Sugihara K. Updated 5-year survival and exploratory T x N subset analyses of ACTS-CC trial: a randomised controlled trial of S-1 versus tegafur-uracil/leucovorin as adjuvant chemotherapy for stage III colon cancer. ESMO Open. 2018 Oct 7;3(6):e000428. doi: 10.1136/esmoopen-2018-000428. eCollection 2018.

    PubMed 30425843

  • Yoshida M, Ishiguro M, Ikejiri K, Mochizuki I, Nakamoto Y, Kinugasa Y, Takagane A, Endo T, Shinozaki H, Takii Y, Mochizuki H, Kotake K, Kameoka S, Takahashi K, Watanabe T, Watanabe M, Boku N, Tomita N, Nakatani E, Sugihara K; ACTS-CC study group. S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial). Ann Oncol. 2014 Sep;25(9):1743-1749. doi: 10.1093/annonc/mdu232. Epub 2014 Jun 18.

    PubMed 24942277

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing folinate calcium, tegafur-uracil and tegafur-gimeracil-oteracil potassium in people with Colorectal Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

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 3 Aug 2016. 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 Japan. 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?

Disease-free survival. 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 NCT00660894, 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 3 Aug 2016.

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