A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

NCT00385970 | Unknown Phase 3 DMC

• 1 other identifier: MCSGO-CCTG-0501
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III colorectal cancer as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 3-Year recurrence-free survival rate

  3-years after surgery

Secondary Outcomes (1)

• 5-Year survival rate, incidence of adverse events, treatment compliance, QOL, type of metastasis/recurrence, and 3-year and 5-year recurrence-free survival rates and survival rates based on each parameter including colon/rectum, stage, and IAP.

  5-years after surgery

Study Arms (2)

1

ACTIVE COMPARATOR

UFT+LV Group: The group treated with UFT and LV

Drug: Tegafur-uracil (UFT); Drug: Calcium folinate (LV)

2

EXPERIMENTAL

UFT+PSK Group: The group treated with of UFT and PSK

Drug: Tegafur-uracil (UFT); Drug: Krestin (PSK)

Interventions

Tegafur-uracil (UFT) DRUG

From within 9 weeks after surgery, 300 mg/m2, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5

Also known as: UFT

1; 2

Calcium folinate (LV) DRUG

From within 9 weeks after surgery, 75 mg, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5

Also known as: LV

1

Krestin (PSK) DRUG

From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day

Also known as: PSK

2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pTNM stage IIB or III (UICC Sixth version) primary colon cancer/rectal cancer who have undergone surgery of histological curability A (including laparoscopic surgery) (the curability is judged after surgery)
• Patients with primary tumor that directly invades other organs or structures and/or perforates into the visceral peritoneum (T4) or with histologically positive lymph node metastasis (N+) (to be judged after surgery)
• Patients who is between 20 and 80 years old at the time of obtaining informed consent
• Patients with performance status of 0 - 2
• Patients without receiving any cancer treatment such as radiation, chemotherapy, and immunotherapy before surgical operation
• Patients without severe dysfunction of renal, hepatic, or bone marrow function
• Patients without serious complications such as bone marrow suppression, diarrhea, and infections diseases
• Patients who have given consent to participate in this clinical study by himself/herself or his/her family

You may not qualify if:

• Patients in whom the bottom of tumor reaches the peritoneal reflection
• Patients with lower rectal cancer (Rb), anal canal (P), or circumanal skin (E)
• Patients who has active multiple cancers or whose disease-free survival is less than 5 years even though the cancers are metachronous (except carcinoma in situ and skin cancers)
• Women who are currently pregnant or wish to be pregnant during this clinical study
• Patients who are judged to be inappropriate to participate in this clinical study by the investigator or subinvestigator

Sponsors & Collaborators

• Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group: lead

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Related Publications (1)

• Ohwada S, Ikeya T, Yokomori T, Kusaba T, Roppongi T, Takahashi T, Nakamura S, Kakinuma S, Iwazaki S, Ishikawa H, Kawate S, Nakajima T, Morishita Y. Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study. Br J Cancer. 2004 Mar 8;90(5):1003-10. doi: 10.1038/sj.bjc.6601619.

  PMID: 14997197 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Tegafur; Leucovorin; polysaccharide-K

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Morito Monden, MD, PhD

  Multicenter Clinical Study Group of Osaka

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Surgery, Osaka National Hospital

Study Record Dates

• First Submitted: October 8, 2006
• First Posted: October 11, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 26, 2012

Record last verified: 2012-10

Locations

JP (1)