A Randomized, Multicenter, Phase III Study to Compare 6 Months of either 5-Fluorouracil / l-leucovorin plus Oxaliplatin (mFOLFOX6) or Capecitabine plus Oxaliplatin (XELOX) with 3 Months of either mFOLFOX6 or XELOX as Adjuvant Chemotherapy in Patients with Completely Resected Stage III Colon Cancer(JFMC47-1202-C3: ACHIEVE Trial) - JFMC47-1202-C3: ACHIEVE Trial

Yoshino Takayuki0 个研究点目标入组 1,291 人开始时间: 2019年2月18日最近更新: 2023年10月17日

适应症

试验速览

The 5-yr OS was 86.4% in 6 mo and 87.0% in 3 mo. HR (95% CI) was 0.91 (0.69-1.20), p=0.5112 (Log-rank). In subgroup analysis, XELOX for 3 mo might be the most appropriate treatment option, especially in patients with low-risk stage III colon cancer. 2. DFS had the same tendency as OS. 3. Adverse events during treatment were less frequent in 3 mo than in 6 mo. Grade 1-3 PSN during treatment was less in XELOX than in mFOLFOX6 and less in 3 mo than in 6 mo. Grade 1-3 PSN decreased year by year.

•(1) Histologically confirmed adenocarcinoma of the colon.
•(2) Predominantly located in the cecum, colon, or rectosigmoid region based on the findings from surgery and/or surgical specimen.
•(3) D2 or D3 lymph nodes resection.
•(4) Curability A surgery (no residual tumor visible to macroscopically and/or microscopically).
•(5) Stage III (T any N1/2/3 M0) (cf. The Japanese Classification of Colorectal Carcinoma, 7th edition, revised version).
•(6) Registration within 8 weeks after resection and chemotherapy starting within 2 weeks after registration.
•(7) Age >= 20 years.
•(8) ECOG performance status of 0-1.
•(9) Body surface area (DuBois) <=2.2 m2.
•(10) No prior chemotherapy, immunotherapy, or radiation therapy.
•(11) Adequate organ function:
•i) neutrophil count >=1,500/mm3
•ii) platelet count >=100,000/mm3
•iii) serum creatinine <=1.5 times the ULN
•iv) CCr >=30mL/min
•v) total bilirubin <=2.0 mg/dL
•vi) AST and ALT <=100 IU/L
•vii) CEA <=10 ng/mL
•(12) Written informed consent.

•(1) Cancer of the appendix.
•(2) Past history of malignancy. (When there is the unrecurred period of 5 or more years, the intramucosal carcinoma [stomach cancer, colorectal cancer, esophagus cancer] by which recovery excision was performed endoscopically, the uterine cervical cancer, the basal cell carcinoma of the skin, and squamous cell carcinoma of the skin by which curative excision was performed can be enrolled.)
•(3) Women who are pregnant or breast-feeding.
•(4) Women who may become pregnant and fertile men.
•(5) Participation in another clinical trial within 30 days before registration.
•(6) Existing grade 1 or more peripheral sensory neuropathy.
•(7) Uncontrolled diabetes mellitus (including insulin therapy).
•(8) Uncontrolled congestive heart failure, angina pectoris, hypertension, and/or arrhythmia.
•(9) Continuous systemic steroid therapy (oral or intravenous administration).
•(10) A history and/or current evidence of significant neurological and/or mental illness.
•(11) Active infectious disease (including known active hepatitis B virus infection, hepatitis C virus infection and human immunodeficiency virus).
•(12) Known dihydropyrimidine dehydrogenase (DPD) deficiency.
•(13) A history of allergy to 5-FU, l-LV, oxaliplatin, and/or capecitabine.
•(14) Prior chemotherapy including oxaliplatin.
•(15) Other reasons for being unfit for the study as determined by the attending physician.

发起方

Yoshino Takayuki