A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Information provided by (Responsible Party):
Masataka Ikeda, MD, PhD., Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
ClinicalTrials.gov Identifier:
NCT00385970
First received: October 8, 2006
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: Tegafur-uracil (UFT) Drug: Calcium folinate (LV) Drug: Krestin (PSK) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group:
Primary Outcome Measures:
- 3-Year recurrence-free survival rate [ Time Frame: 3-years after surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 380 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
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 |
| Study First Received: | October 8, 2006 |
| Last Updated: | October 25, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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 Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Antidotes Protective Agents Antibiotics, Antineoplastic Antiviral Agents |
ClinicalTrials.gov processed this record on May 22, 2013