Clinical trial · Interventional
A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
NCT00385970CI-TRIAL-00008342unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium folinate (LV) | Drug | Immunomodulatory Oligonucleotide | ALIAS |
| Krestin (PSK) | Drug | — | UNRESOLVED |
| Tegafur-uracil (UFT) | Drug | Tegafur | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- UFT+LV Group: The group treated with UFT and LV
- interventionNames
- Drug: Tegafur-uracil (UFT)
- Drug: Calcium folinate (LV)
- type
- EXPERIMENTAL
- label
- 2
- description
- UFT+PSK Group: The group treated with of UFT and PSK
- interventionNames
- Drug: Tegafur-uracil (UFT)
- Drug: Krestin (PSK)
Primary outcomes (1)
- measure
- 3-Year recurrence-free survival rate
- timeFrame
- 3-years after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDOhwada 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