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

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ClinicalTrials.gov Identifier: NCT00385970
Recruitment Status : Unknown
Verified October 2012 by Masataka Ikeda, MD, PhD., Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group.
Recruitment status was:  Active, not recruiting
First Posted : October 11, 2006
Last Update Posted : October 26, 2012
Sponsor:
Information provided by (Responsible Party):
Masataka Ikeda, MD, PhD., Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Tegafur-uracil (UFT) Drug: Calcium folinate (LV) Drug: Krestin (PSK) Phase 3

Detailed Description:
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 (UICC Sixth version) colorectal cancer/histological curability A (Japanese Classification of Colorectal Carcinoma, Sixth version) 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
Study Start Date : March 2006
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
UFT+LV Group: The group treated with UFT and LV
Drug: Tegafur-uracil (UFT)
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
Other Name: UFT
Drug: Calcium folinate (LV)
From within 9 weeks after surgery, 75 mg, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5
Other Name: LV
Experimental: 2
UFT+PSK Group: The group treated with of UFT and PSK
Drug: Tegafur-uracil (UFT)
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
Other Name: UFT
Drug: Krestin (PSK)
From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day
Other Name: PSK



Primary Outcome Measures :
  1. 3-Year recurrence-free survival rate [ Time Frame: 3-years after surgery ]

Secondary Outcome Measures :
  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. [ Time Frame: 5-years after surgery ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385970


Locations
Japan
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sponsors and Collaborators
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Investigators
Study Chair: Morito Monden, MD, PhD Multicenter Clinical Study Group of Osaka

Publications:
Responsible Party: Masataka Ikeda, MD, PhD., Associate Director of Surgery, Osaka National Hospital, Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00385970     History of Changes
Other Study ID Numbers: MCSGO-CCTG-0501
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Tegafur
Krestin
Leucovorin
Levoleucovorin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Adjuvants, Immunologic
Immunologic Factors
Antibiotics, Antineoplastic
Antiviral Agents