PhaseIII trial of neoadjuvant chemotherapy using CAPEOX with optional local treatment for locally advanced rectal cancer

PhaseIII trial of neoadjuvant chemotherapy using CAPEOX with optional local treatment for locally advanced rectal cancer - NEXT trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032254

Enrollment

440

Registered

2018-08-01

Start date

2019-08-01

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

Locally advanced rectal cancer

Interventions

Preoperative chemoradiation (Capecitabine + Radiation 50.4Gy) + Surgery(optional LLND) Neoadjuvant chemotherapy (CAPEOX 4 course)+optional preoperative chemoradiation + Srugery(optional LLND)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age 20-80 2) Adenocarcinoma proven histologically 3) Lower edge of rectal cancer is less than 10cm from anal verge 4) ECOG Performance Status(PS)0-1 5) Clinical StageII/III (excluded cT4b) 6) Resectable rectal cancer. 7) No prior chemotherapy, radiotherapy and rectal surgery without local resection. 8) Adequate organ function to performed surgery. 1. WBC>=3,000/mm3 2. Neutrophils >=1,500/mm3 3. Hb>=8.0g/dl 4. Plt >=100,000/mm3 5. GOT <=100IU/L 6. GPT <=100IU/L 7. T-Bil <= 2.0mg/dl 8. Cr <= 1.5mg/dl 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years)malignancies other than carcinoma in situ or mucosal carcinoma 2) Bowel obstruction 3) Uncontrollable diabetes mellitus (HbA1c>=8.0) 4) Unstable ungina pectoris 5) Liver cirrhosis,Liver failure 6) Interstitial pneumonia 7) Pregnant or possibly pregnant women 8) Past history of using 5-FU, oxaliplatin based chemotherapy 9) Past history of radiotherapy 10) Other conditions judged ineligible by physician

Design outcomes

Primary

Measure	Time frame
5-year relapse free survival	—

Secondary

Measure	Time frame
CRM positive rate, CRT rate, LLND rate, R0 rate, morbidity rate, response rate of neoadjuvant chemotherapy/chemoradiotherapy and completion rate, 5-year local recurrence rate, 5-year overall survival	—

Countries

Japan

Contacts

Public ContactAtsushi Ishibe

Yokohama City University Dept. of Gastroentelorogical Surgery

aishibe@yokohama-cu.ac.jp045-787-2650

Outcome results

None listed

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