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A phase II study of TEGAFOX as adjuvant therapy for elderly patients with stage III and stage II colorectal cancer with risk factors for recurrence.

A phase II study of TEGAFOX as adjuvant therapy for elderly patients with stage III and stage II colorectal cancer with risk factors for recurrence. - A phase II study of TEGAFOX as adjuvant therapy for with stage III and stage II colorectal cancer with risk factors for recurrence.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010589
Enrollment
75
Registered
2013-04-30
Start date
2013-04-12
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

colon cancer

Interventions

UFT 300mg per m2 per day and LV 75mg per day for 28 days Oxaliplatin:85mg/m2 day1,15 every 5-weeks for 3-cycle After this therapy, followed by UFT/LV 2-cycle

Sponsors

Toho University Medical Center Omori hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)with histologically confirmed colorectal cancer 2)with histologically confirmed stageIII and stageII colorectal cancer stageII:has at least one of the following factors -ileus -vascular invasion-positive -T4 -poorly differentiated adenocarcinoma or undifferentiated carcinoma -perforaiton -lymph node dissection:less than 12 3)>=D2 lymph node dissection 4)Pathological curability is A or B 5)is aged 70 and over 6)Performance status 0-1 7)Without prior anti-tumor therapy 8)Adequate organ function 9)can start the therapy within 8weeks after surgery. 10)can take drugs orally. 11)whose written consent is taken.

Exclusion criteria

Exclusion criteria: 1)Multiple malignancies within five years 2) Other severe complications, such as pulmonary emphysema, pulmonary fibrosis, hyper pulmonary emphysema,paralysis intestinal, intestinal obstruction, uncontrollable diabetes, cirrhosis, uncontrollable hypertension, myocardial infarction within six months, angina. 3)has severe diarrhea 4)with psychosis or psychoneyrosis 5) In case that the doctor judged that he/she is disqualified for the enrollment in this clinical trial.

Design outcomes

Primary

MeasureTime frame
feasibility

Countries

Japan

Contacts

Public ContactKimihiko Funahashi

Toho University Medical Center Omori hospital Depaetment of Gastoroenterological Surgery

kingkong@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

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