HiSCO 03 study

JRCT ID: jRCTs061180087

Registered date:22/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Colorectal cancer
• Date of first enrollment: 17/12/2013
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Start protocol treatment within 8 weeks after surgery.
If it was not possible to start within 8 weeks after surgery, state the reason on the treatment progress record sheet.
Test treatment
UFT is administered orally three times a day (about every 8 hours) avoiding one hour before and after meal, dividing equivalent amount of 300 to 600 mg of tegafur (300 mg/m 2/day). LV (Uzel tablet) is 75 mg/day divided three times a day, and it is orally administered simultaneously with UFT. This is administered for 28 consecutive days, followed by 7 days off. As this is one course, we will implement 5 courses (25W).

Outcome(s)

Primary Outcome

Feasibility

An aborted case because of the reason of 1) or 2) is regarded as an event. An aborted case because of the reason of 3) to 5) is regarded as a censored case and calculated the cumulative completion rate by the Kaplan-Meier method or the like. For the calculation of the confidence interval of the cumulative completion rate at 25 weeks after UFT / LV administration, Greenwood's equation is used.
1) Canceling due to side effects.
2) Canceling due to patient refusal.
3) Canceling due to complications after curative treatment.
4) Canceling due to recurrence or death.
5) Canceling cases due to patient transfers.

Secondary Outcome

Safety, OverallSurvival, Relapse-freeSurvival, Disease-free Survival, Relative Dose Intensity

Regardless of eligibility, the number of patients who undergo any protocol treatment is included into analysis of the severity and the rate of occurrence of the following adverse event (toxicity) according to the classification of CTCAE v4.0. However, in cases where study treatment are discontinued, evaluation shall be carried out until the date of discontinuation. Fisher's exact test is used for the comparison between groups, and an accurate confidence interval of binomial distribution is used for interval estimation.
Blood / bone marrow: hemoglobin, white blood cells, neutrophils, platelets
Systemic symptoms: fever
Dermatology / skin: hand and foot skin reaction, pigment abnormality
Gastrointestinal: anorexia, diarrhea, nausea, olfactory, ulcer / sore throat, taste disorder (dysgeusia), vomiting
Liver: bilirubin, AST, ALT
Infection / febrile neutropenia: febrile neutropenia, infection with grade 3-4 neutropenia, infection without neutropenia
Metabolism / Inspection: High / low hyponatremia, hyperkalemia
Neurology: neuropathy - motility
Kidney / genitourinary tract: creatinine

Key inclusion & exclusion criteria

• Age minimum: >= 80age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Colorectal cancer patients (Histologically confirmed)
2. Stage III colorectal cancer patients
3. Patients who underwent R0 resecrion
4. ECOG Performance Status : 0 to 2
5. 80 years or more
6. No previous history of chemotherapy or radiotherapy for colorectal cancer
7. Within 8 weeks after operation
8. Adequate organ funcion
White blood cell count : greater than or equal to 3,000/mm3 and less than 12,000/mm3
Neutrophil : greater than or equal to 1,500/mm3
Platelet : greater than or equal to 7.5 x 104/mm3
Hemogrobin : greater than or equal to 9.0g/dL
Total bilirubin : less than or equal to 1.5mg/dL
AST(GOT), ALT(GPT) : less than or equal to 100IU/L
Serum creatinine : less than or equal to 1.5mg/dL
9. Oral food intake possible
10. Written informed consent

Exclude criteria

1.History of serious drug hypersensivity
2.Watery diarrhea
3.Cases with severe postoperative complication
4.Sever comorbidity
5.Synchronous or meachronous multiple malignancy within tha last 5 years disease free interval
6.Patients who have cognitive impairment or psychiatric disorder
7.Taking oral administration of warfarin potassium

Related Information

• Primary Sponsor: Ohdan Hideki
• Secondary Sponsor: Hiroshima Surgical study group of Clinical Oncology,Hiroshima Surgical study group of Clinical Oncology,Hiroshima Surgical study group of Clinical Oncology
• Secondary ID(s): UMIN000011899