Clinical trial NCT00497107: Uracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer
Official title: Phase III Randomized Controlled Clinical Study of UFT/LV Therapy Versus UFT/LV + PSK Therapy as Postoperative Adjuvant Therapy for Histological Stage IIIa and IIIb Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: UFT/LV
PSK
Colorectal cancer
Adjuvant therapy
Lead sponsor: Iwate Medical University
Sponsor class: OTHER
First posted: 2007-07-06
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a randomised controlled trial (RCT) comparing UFT/LV and UFT/LV + PSK in patients with histological stage IIIa/IIIb colorectal cancer who have undergone curative surgery without residual cancer using 3-year disease free survival (DFS) as the primary endpoint, and also to analyze the 3-year overall survival (OS), compliance, adverse events, quality of life (QOL) and relationship with tumor factors.

Detailed description: To conduct a randomized controlled trial comparing chemotherapy using UFT/LV and immunochemotherapy using UFT/LV combined with PSK in patients with histological stage IIIa and IIIb colorectal cancer (adenocarcinoma) who have undergone curative surgery without residual cancer (R0) using 3-year disease-free survival rate as primary endpoint, and also to analyze the 3-year overall survival, compliance, adverse events, QOL and relationship with tumor factors.

Eligibility criteria: Inclusion Criteria:

* Patient with a histological diagnosis of primary colon or rectal cancer (adenocarcinoma)
* Patient with histological stage IIIa or IIIb cancer (according to the Japanese Classification of Colorectal Cancer, 7th edition)
* Patient who has undergone curative surgery with no residual cancer
* Pretreatment criterion: patient who has not undergone preoperative cancer treatment (radiotherapy, chemotherapy or immunotherapy)
* Patient who is at least 20 years and below 80 years of age
* Patient with performance status (PS) of 0-1 (according to Eastern Cooperative Oncology Group, ECOG)
* Restrictions of concomitant medications and therapies: except in the case of metastasis or recurrence, concomitant use of other chemotherapeutic and immunotherapeutic agents that may affect the results of this trial, and concomitant use of radiotherapy are prohibited in principle.
* Organ function (laboratory data): patient who satisfies the following conditions or data of laboratory tests conducted within 2 weeks prior to start of trial

  * Gastrointestinal function: no diarrhea (watery stool)
  * White blood cell count: \> 4,000/mm3
  * Platelet count: \> 100,000/mm3
  * Serum GOT and GPT: \< 100 IU/L
  * Serum total bilirubin: \< 2.0 mg/dL
  * Serum creatinine: below the upper limit of facility normal range

Exclusion Criteria:

* Patient with residual cancer (R1 or R2)
* Patient with anal canal lesion (P) or perianal skin lesion (E)
* Patient with stricture and not capable of oral intake
* Patient passing fresh blood from the gastrointestinal tract
* Patient with retention of body cavity fluid necessitating treatment
* Patient with infection, intestinal palsy or intestinal occlusion
* Patient with active multiple cancers or patient who has less than 5 years of remission from a metachronous cancer (except carcinoma in situ and skin cancer)
* Patient who is pregnant or wishes to become pregnant during this trial
* Patient on continuous insulin treatment for diabetes or has poorly controlled diabetes
* Patient with a history of ischemic heart disease and judged to have difficulties to participate in this trial
* Patient with concurrent psychiatric disease or neurological symptoms and judged to have difficulties to participate in this trial
* Patient on continuous steroid therapy
* Patient with a history of serious drug allergy
* Patient who is judged for other reasons by the investigator or doctor in charge to be inappropriate as a subject

Primary outcomes:
measure: Disease-free survival
timeFrame: 3-years
Secondary outcomes:
measure: Overall survival, compliance, adverse events, QOL, tumor markers
timeFrame: 3-years
Other outcomes:
Locations:
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
Study officials:
affiliation: Iwate Clinical Oncology Group
name: Go Wakabayashi, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Lembersky BC, Wieand HS, Petrelli NJ, O'Connell MJ, Colangelo LH, Smith RE, Seay TE, Giguere JK, Marshall ME, Jacobs AD, Colman LK, Soran A, Yothers G, Wolmark N. Oral uracil and tegafur plus leucovorin compared with intravenous fluorouracil and leucovorin in stage II and III carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project Protocol C-06. J Clin Oncol. 2006 May 1;24(13):2059-64. doi: 10.1200/JCO.2005.04.7498.