Multicenter phase II study of CapeOX (XELOX) with stop-and-go strategy as adjuvant chemotherapy in high-risk Stage II or Stage III colon and rectal cancer

Multicenter phase II study of CapeOX (XELOX) with stop-and-go strategy as adjuvant chemotherapy in high-risk Stage II or Stage III colon and rectal cancer - COACH Trial (CCOG 1302)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012535

Enrollment

200

Registered

2013-12-09

Start date

2013-12-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk Stage II or stage III colon and rectum cancer(above the peritoneal reflection)

Interventions

CapeOX(XELOX) (8 courses) Oxaliplatin 130mg/m2 day1 Capacitabine 2000mg/m2 day1 - 15(bid) every 3 weeks (1)Initial therapy(2 courses) : CapeOX therapy (2)Maintenance therapy(4 courses) : Capecit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Written informed consent (2) D2 or D3 lymph nodes resection and Curability A surgery (no residual tumor visible to macroscopically and/or microscopically). (3) Predominantly located in the cecum, colon, rectosigmoid region or rectum (above the peritoneal reflection) based on the findings from surgery and/or surgical specimen. (4) Pathological Stage III or High risk Stage II : High risk Stage II, defined as those with poor prognostic features, including 1) T4 tumors (UICC TNM 7th edition) 2) Bowel obstruction 3) Perforation 4) <12 lymph nodes examined 5) Poorly differentiated histology 6) Vascular or Lymphatic invasion (5) Registration and chemotherapy starting within 8 weeks after resection. (6) Age: 20-80 years (7) Performance status (PS) 0-1 (8) A life expectancy greater than 3 months (9) No prior chemotherapy, immunotherapy, or radiation therapy. (10) Adequate organ function

Exclusion criteria

Exclusion criteria: (1)Appendix cancer or anal cancer (2)Distal extent of tumor must be in the Rb (3)Multiple malignacies to be treated (4)Ileus, bowel obstruction or uncontrolled peptic ulcer. (5)Uncontrolled severe complications(DM, hypertension, diarrhea, et al.) (6)Massive pleural effusion or ascites that required drainage. (7) Patient with symptomatic cardiovascular disease or asymptomatic disease but has been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (8) A history of allergy to 5-FU, platina, or Known dihydropyrimidine dehydrogenase (DPD) deficiency. (9)Severe neuropathy (10)With interstitial lung disease or pulmonary fibrosis (11)Continuous systemic steroid therapy (oral or intravenous administration). (12)A history and/or current evidence of significant neurological and/or mental illness. (13)Pregnant (14)Without intention to contraception (15)Prior chemotherapy including Oxaliplatin or Capecitabin (16)Not appropriate for the study at the physician's assessment.

Design outcomes

Primary

Measure	Time frame
The frequency of peripheral sensory neuropathy 12 months after the treatment	—

Secondary

Measure	Time frame
"Disease-free survival rate Relaps-free survival rate Overall survival rate Oxaliplatin induced neuropathy rate Relative dose intensity Safety	—

Countries

Japan

Contacts

Public ContactMiyuki Aoki

Chubu Clinical Oncology Group (CCOG) Data Center

goro@med.nagoya-u.ac.jp(81)52-744-2253

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026