Phase II multicenter study of neoadjuvant chemotherapy with XELOX for locally advanced rectal cancer

Phase II multicenter study of neoadjuvant chemotherapy with XELOX for locally advanced rectal cancer - KYNAC 02

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024357

Enrollment

Registered

2016-10-11

Start date

2016-10-31

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

Stage II or III rectal cancer

Interventions

Capecitabine: at a dose of 1000mg/m2 twice daily on days 1-14, 22-35,43-56,63-76 Oxaliplatin: at a dose of 130mg/m2 on days 1, 22,43,63 Surgical resection: 2-8 weeks after the completion of chemot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the rectum 2.Patients with cT4 or cN2/3 3. Tumor with inferior edge located below peritoneal reflection 4. Without history of chemotherapy or radiotherapy for rectal cancer 5. Eastern Cooperative Oncology Group performance status of 0 or 1 6. Adequate organ function i) WBC >=3,000/mm3 ii) Neutrophil count >=1,500/mm3 iii) Platelet count >=100,000/mm3 iv) Serum bilirubin <=2.0mg/dl v) AST <=100IU/l vi) ALT <=100IU/l vii) Serum creatinine <=1.5mg/dl 7. Written study-specific informed consent

Exclusion criteria

Exclusion criteria: 1. With distant metastasis (M1) 2. Cancerous fluid 3. Active infectious disease 4. Concomitant malignancy (within 5 years) and double cancer 5. Uncontrolled diabetic 6. Peripheral neuropathy 7. Serious lung disease 8. Clinically significant cardiac disease 9. Pregnant women and nursing mothers, possibly pregnant women, and men attempting to conceive a child 10. Other conditions judged ineligible by physician

Design outcomes

Primary

Measure	Time frame
R0 resection rate	—

Secondary

Measure	Time frame
completion rate of the scheduled chemotherapy,Pathologic response rate,pathological complete response rate,downstage rate, OS, DFS, Local recurrence rate, Rate of sphincter-preservation, Completion rate of postoperative adjuvant chemotherapy, acute toxicity, postoperative complications,postoperative defecation	—

Countries

Japan

Contacts

Public ContactTatsuya Manabe,MD

Graduate School of Medical Sciences, Kyushu University Surgery and Oncology

manabe@surg1.med.kyushu-u.ac.jp092-642-5440

Outcome results

None listed

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