Colorectal CancerPhase 3NCT00385970
A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
A Phase 3 study testing Tegafur-uracil (UFT), Calcium folinate (LV) and Krestin (PSK) in people with Colorectal Cancer, run by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Tegafur-uracil (UFT), Calcium folinate (LV) and Krestin (PSK)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2006to Apr 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Tegafur-uracil (UFT), Calcium folinate (LV), Krestin (PSK)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegafur-uracil (UFT)Drug
Also called 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
Calcium folinate (LV)Drug
Also called 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
Krestin (PSK)Drug
Also called PSK
From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | UFT+LV Group: The group treated with UFT and LV Receives: Drug: Tegafur-uracil (UFT); Drug: Calcium folinate (LV) |
| 2 | Experimental | UFT+PSK Group: The group treated with of UFT and PSK Receives: Drug: Tegafur-uracil (UFT); Drug: Krestin (PSK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Year recurrence-free survival rate
Measured: 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.
Measured: 5-years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startMar 2006
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masataka Ikeda, MD, PhD., Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
- Investigators
- Morito Monden, MD, PhD, Study chair, Multicenter Clinical Study Group of Osaka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385970
- Sponsor's protocol ID
- MCSGO-CCTG-0501
- Status last verified
- Oct 2012
- First submitted
- 8 Oct 2006
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 14997197
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00385970
- Acronym / sponsor ID
- MCSGO-CCTG-0501
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment GroupUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tegafur-uracil (UFT), Drug: Calcium folinate (LV)UFT+LV Group: The group treated with UFT and LV |
| 2 | Experimental | Drug: Tegafur-uracil (UFT), Drug: Krestin (PSK)UFT+PSK Group: The group treated with of UFT and PSK |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tegafur-uracil (UFT)Also: UFTFrom within 9 weeks after surgery, 300 mg/m2, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5 | Drug | 1, 2 |
| Calcium folinate (LV)Also: LVFrom within 9 weeks after surgery, 75 mg, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5 | Drug | 1 |
| Krestin (PSK)Also: PSKFrom within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day | Drug | 2 |
Primary outcome
3-Year recurrence-free survival rate
Time frame: 3-years after surgery
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
- Background: PubMed 14997197Ohwada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morito Monden, MD, PhD study chair
Multicenter Clinical Study Group of Osaka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tegafur-uracil (UFT), Calcium folinate (LV) and Krestin (PSK) in people with Colorectal Cancer, run by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Year recurrence-free survival rate (time frame: 3-years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00385970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2012.