Uracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer (ICOG)

Iwate Medical University

Status and phase

Unknown

Phase 3

Conditions

Colorectal Cancer

Treatments

Drug: UFT, Calcium Folinate

Drug: UFT, Calcium Folinate, PSK

Study type

Interventional

Funder types

Other

Identifiers

NCT00497107

ICOG-CC01

Details and patient eligibility

About

The purpose of this study is to conduct a randomised controlled trial (RCT) comparing UFT/LV and UFT/LV + PSK in patients with histological stage IIIa/IIIb colorectal cancer who have undergone curative surgery without residual cancer using 3-year disease free survival (DFS) as the primary endpoint, and also to analyze the 3-year overall survival (OS), compliance, adverse events, quality of life (QOL) and relationship with tumor factors.

Full description

To conduct a randomized controlled trial comparing chemotherapy using UFT/LV and immunochemotherapy using UFT/LV combined with PSK in patients with histological stage IIIa and IIIb colorectal cancer (adenocarcinoma) who have undergone curative surgery without residual cancer (R0) using 3-year disease-free survival rate as primary endpoint, and also to analyze the 3-year overall survival, compliance, adverse events, QOL and relationship with tumor factors.

Enrollment

300 estimated patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with a histological diagnosis of primary colon or rectal cancer (adenocarcinoma)
Patient with histological stage IIIa or IIIb cancer (according to the Japanese Classification of Colorectal Cancer, 7th edition)
Patient who has undergone curative surgery with no residual cancer
Pretreatment criterion: patient who has not undergone preoperative cancer treatment (radiotherapy, chemotherapy or immunotherapy)
Patient who is at least 20 years and below 80 years of age
Patient with performance status (PS) of 0-1 (according to Eastern Cooperative Oncology Group, ECOG)
Restrictions of concomitant medications and therapies: except in the case of metastasis or recurrence, concomitant use of other chemotherapeutic and immunotherapeutic agents that may affect the results of this trial, and concomitant use of radiotherapy are prohibited in principle.
Organ function (laboratory data): patient who satisfies the following conditions or data of laboratory tests conducted within 2 weeks prior to start of trial
- Gastrointestinal function: no diarrhea (watery stool)
- White blood cell count: > 4,000/mm3
- Platelet count: > 100,000/mm3
- Serum GOT and GPT: < 100 IU/L
- Serum total bilirubin: < 2.0 mg/dL
- Serum creatinine: below the upper limit of facility normal range

Exclusion criteria

Patient with residual cancer (R1 or R2)
Patient with anal canal lesion (P) or perianal skin lesion (E)
Patient with stricture and not capable of oral intake
Patient passing fresh blood from the gastrointestinal tract
Patient with retention of body cavity fluid necessitating treatment
Patient with infection, intestinal palsy or intestinal occlusion
Patient with active multiple cancers or patient who has less than 5 years of remission from a metachronous cancer (except carcinoma in situ and skin cancer)
Patient who is pregnant or wishes to become pregnant during this trial
Patient on continuous insulin treatment for diabetes or has poorly controlled diabetes
Patient with a history of ischemic heart disease and judged to have difficulties to participate in this trial
Patient with concurrent psychiatric disease or neurological symptoms and judged to have difficulties to participate in this trial
Patient on continuous steroid therapy
Patient with a history of serious drug allergy
Patient who is judged for other reasons by the investigator or doctor in charge to be inappropriate as a subject