Japanese phase II trial of NEoadjuvant chemotherapy Using TRiplet for borderline resectable Advanced rectaL cancer

Japanese phase II trial of NEoadjuvant chemotherapy Using TRiplet for borderline resectable Advanced rectaL cancer - NEUTRAL trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032871

Enrollment

Registered

2018-06-11

Start date

2018-10-22

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

borderline resectable advanced rectal cancer

Interventions

Radical surgery after 6cources of neoadjuvant FOLFOXIRI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Lower rectal cancer patients with cT4a with circumferential resection margin<1mm or cT4b or cN2/3 2. Histologically proven adenocarcinoma of the rectum 3.Tumor with inferior edge located below peritoneal reflection 4.Without history of chemotherapy or radiotherapy for rectal cancer 5. Performance status (PS) 0-1 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 <=1.3mg/dl 7. Indication for laparoscopic surgery 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. With distant metastasis (M1) 2. Transfusion of blood derivative within 14 days 3. Existence of cancer cells in ascites 4. With active infection 5. Synchronous or metachronous malignant tumor 6. uncontrolled diabetes mellitus 7. History of severe drug hypersensitivity 8. History of sensational abnormality 9. With interstitial lung disease or pulmonary fibrosis 10. Severe heart failure 11. Pregnant 12. Patients who do not give written informed consent.

Design outcomes

Primary

Measure	Time frame
R0 resection rate	—

Secondary

Measure	Time frame
completion rate of the scheduled chemotherapy, pathological complete response rate, rate of tumor shrinkage, pathological response, clinical response rate, downstage rate, overall survival, recurrence-free survival, rate of sphincter-preserving surgery, administration rate of adjuvant chemotherapy, adverse event, postoperative complication	—

Countries

Japan

Contacts

Public ContactKinuko Nagayoshi

Graduate School of Medical Sciences, Kyushu University Surgery and Oncology

nagayoshi.kinuko.232@m.kyushu-u.ac.jp092-642-5440

Outcome results

None listed

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