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Feasibility study of Capecitabine as adjuvant chemotherapy for stage III colon cancer including RS cancer.

Feasibility study of Capecitabine as adjuvant chemotherapy for stage III colon cancer including RS cancer. - Feasibility study of Capecitabine as adjuvant chemotherapy for stage III colon cancer including RS cancer. (KSCC0803 study)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001444
Enrollment
92
Registered
2008-10-22
Start date
2008-07-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stage III colon cancer including RS cancer

Interventions

Capecitabine is administrated orally as tablets, 2,500 mg/m2 daily for 14 days followed by a 7-days resting period without treatment, as an intermittent therapy in a 3-weeks cycle for 8 treatment cycl

Sponsors

KSCC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed Colorectal adenocarcinoma 2)Histological Stage III Colon,Rectosigmoid 3)Curative resection with D2 or more lymph node dissection 4)Resection of histological curability A was performed 5)age:20-80years old 6)Performance status(ECOG):0or1 7)No prior chemotherapy and radiotherapy 8)Oral intake is possible 9)Sufficient organ functions 10)Chemotherapy will be started within 8 weeks from operation 11)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Pregnant or nursing 2)Medical history of allergy or hypersensitivity reactions to fluoropyrimidines 3)The past of the internal organ transplant 4)Serious coexisting illness a;severe pulmonary dysfunction b;ileus or colon dysfunction c;uncontrolled diabetes mellitus d;liver cirrhosis e;uncontrolled hypertension f;history of myocardial infarction, unstable angina within 6 months prior to the registration 5)Active synchronous or metachronous malignancy other than carcinoma in situ 6)Uncontrollable infectious disease 7)Not suitable for participating in the study for any other reason

Design outcomes

Primary

MeasureTime frame
the rate of completion of treatment as planned

Secondary

MeasureTime frame
Safety Cumulative incidence of Hand-foot syndrome and hepatic dysfunction 3-years disease free survival rate 5-years disease free survival rate 3-years overall survival rate 5-years overall survival rate

Countries

Japan

Contacts

Public ContactKSCC

CReS Kyushu KSCC

kscc2@cres-kyushu.or.jp092-631-2920

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026