Local excision with postoperative chemoradiotherapy for T1, T2 rectal cancer

Local excision with postoperative chemoradiotherapy for T1, T2 rectal cancer - T1, T2 Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011417

Enrollment

Registered

2013-08-15

Start date

2002-12-01

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

T1,T2 cancer of low rectum

Interventions

Local excision Postoperative chemoradiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Primary rectal cancer located within lower rectum 2. Clinical T1 or T2, N0, M0 3. Tumor size within 3cm, and possible to be curative local excision 4. Without severe complications. PS(ECOG) of 0 or 1 5. Pathological proven well or moderately adenocarcinoma 6. First treatment of rectal cancer 7. Without synchronous or metachronous ( within 5 years ) malignancies 8. written informed consent 9. Aged 20 to 75 years old. Pathological proven well or moderately adenocarcinoma in resected specimen 10. Depth of sm-massive invasion, or with lymphatic or venous vessels invasion, or depth of mp invasion 11. Pathological negative surgical margins in resected specimen 12. Enough organ functions i. WBC count : >=3000/mm3 ii. Platelet count : >=100,000/mm3 iii. T-Bil : <=1.5mg/dl iv. AST/ALT : <=100IU/l v. Cr : <=1.5mg/dl Normal ECG

Exclusion criteria

Exclusion criteria: 1. Pathological proven poorly or mucinous adenocarcinoma by biopsy 2. Clinical N positive 3. Distant metastasis 4. PS (ECOG) 2, 3, and 4 5. Without written informed consent 6. Pathological proven poorly or mucinous adenocarcinoma in resected specimen 7. Pathological positive surgical margins in resected specimen 8. Depth of m invasion, or sm-minute invasion without vessels invasion 9. Bone marrow dysfunction 10. Be certain or suspicious pregnant 11. Precious radiotherapy in abdomino-pelvic area 12. Unsuitable patients for this study

Design outcomes

Primary

Measure	Time frame
Disease free survival at five years	—

Secondary

Measure	Time frame
Overall survival at five years Local relapse-free survival Salvage treatment and prognosis Adverse events in chemoradiotherapy	—

Countries

Japan

Contacts

Public ContactNorio Saito

National Cancer Center Hospital East Colorectal and Pelvic Surgery

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

Outcome results

None listed

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