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Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer after the local resection

Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer after the local resection - Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016785
Enrollment
35
Registered
2015-03-12
Start date
2015-03-11
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

rectal cancer

Interventions

Sponsors

National Cancer Center Hospital East
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Rectal cancer 2) Local resection is performed within 12 weeks before registration day. 3) En bloc resection and margins negative 4) Histopathologically, the lesion is pSM cancer and it satisfies any one or more of the following conditions. 1. poorly differentiated adenocarcinoma 2. depth of submucosal invasion more than 1mm 3. lymphovascular invasion positive 4. budding Grade 2,3 5) No lymph node metastases and distant metastasis in diagnostic imaging within 16 weeks before registration 6) Rejection of the surgery 7) ECOG Performance Status PS:0,1 8) No history of the chemotherapy and radiotherapy 10) Blood data 1. WBC>3000/mm3 2. Hb>9.0g/dL 3. Plt>100,000/mm3 4. AST,ALT<100 IU/L 5. t-bil<2.0mg/dL 6. Cr<1.5mg/dL 11) Agreement from the patients

Exclusion criteria

Exclusion criteria: 1)Presence of synchronous or metachronous advanced colorectal cancer and malignant diseases in any other organs 2)Pregnant woman 3)Patients with psychosis 4)Use of the phenytoin and warfarin potassium 5)Use of steroids 6)Activity of hepatitis B or hepatitis C 7)Systemic infection 8)Others

Design outcomes

Primary

MeasureTime frame
The rate of treatment completion

Countries

Japan

Contacts

Public ContactMasaaki Noguchi

National Cancer Center Hospital East Department of Gastroenterology & Gastrointestinal Oncology

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

Outcome results

None listed

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