A Phase II/III Randomized multicenter Trial of Intersphincteric resection (ISR) with or without Preoperative Chemotherapy for very low-lying Rectal Cancer

A Phase II/III Randomized multicenter Trial of Intersphincteric resection (ISR) with or without Preoperative Chemotherapy for very low-lying Rectal Cancer - Neo-adjuvant chemotherapy for Intersphincteric resection (ISR) in Low Rectal Cancers NAIR. Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009510

Enrollment

200

Registered

2012-12-20

Start date

2013-01-04

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

Very Low Rectal Cancer

Interventions

A : ISR plus adjuvant chemotherapy B : ISR with neoadjuvant chemotherapy plus adjuvant chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Primary rectal cancer located within 5cm from the anal verge, or located within 3cm from the dentate line. 2) Pathological proven adenocarcinoma. 3) Clinical T3 N any M0 4) No invasion to the external sphincter by preoperative imaging diagnosis 5) Possible to be curative resection 6) Aged 20 to 75 years old 7) Enough organ functions i. WBC count > 3,000/mm3 ii. Platelet count > 100,000/ mm3 iii. Hemoglobin > 8.0 g/dl iv. AST < 100 IU/L v. ALT < 100IU/L vi. T.Bil < 2.0mg/dl vii. Cr < 1.5mg/dl viii. PT Consumption > 50% 8) PS of 0 or 1 9) Without previous radiotherapy and chemotherapy 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with request of abdominoperineal resection (APR) 2) Patients with impossibility for ISR 3) Patients with poor anal function preoperatively 4) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in site or mucosal carcinoma 5) Patients with serious diseases as follows i. Uncontrollable diabetes mellitus ii. Uncontrollable hypertension iii. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema 6) Chronic active hepatitis type B. Positive for HCV 7) Episodes of blood transfusion within the post 14 days 8) Patients with severe mental disease 9) Cannot agree on this study 10) Unsuitable patients for this study

Design outcomes

Primary

Measure	Time frame
PhaseII : Evaluation of safety in all treatment course ( operation, chemotherapy) PhaseIII : Disease free survival at three years	—

Secondary

Measure	Time frame
Overall survival at three years, Rate of curative operation. Postoperative anal function and QOL, Tumor response to neoadjuvant chemotherapy, adverse events in chemotherapy,	—

Countries

Japan

Contacts

Public ContactYuichiro Tsukada

National Cancer Center Hospital East Colorectal and Pelvic Surgery

yutsukad@east.ncc.go.jp04-7133-1111

Outcome results

None listed

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