Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy

Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy - Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037000

Enrollment

Registered

2019-06-10

Start date

2018-04-01

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

Rectal cancer

Interventions

Xeloda was given orally after breakfast and dinner on Days 1 to 5, 8 to 12, 22 to 26, and 29 to 33. Radiotherapy was administered in fractions of 1.8 Gy/d, given 5 days per week for 5 weeks. The tot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Main part of the tumor is located in P-Rb. 2) Previously untreated lower rectal cancer with preoperative diagnosis of T1/2 and N0 and M0. 3) Tumor diameter=< 30mm. 4) Well differentiated adenocarcinoma or Moderately differentiated adenocarcinoma. 5) No prior therapy expect the operation. 6) No severe complications 7) Age >= 20 years 8) Performance status (ECOG) of 0-1 9) Capability of oral intake 10) Patients who have satisfied the following the clinical test values within two weeks before the registration. i. WBC: 3,500-12,000 /mm3 ii. Neutrophile >= 1,500/mm3 iii. Platelet > = 100,000/mm3 iv. Hemoglobin > = 9.0g/dL v. Total bilirubin =< 2.0 mg/dL vi. AST =< 100IU/L vii. ALT =< 100IU/L viii. Ccr >= 30 ml/min 11) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Active synchronous or metachronous malignancy carcinoma in situ. 2) Non-treated radiotherapy 3) Medical history of severe anaphylaxis or allergia to any drug. 4) Severe diarrhea. 5) Undergoing treatment with Tegafur, Gimeracil, Oteracil Potassium. 6) Undergoing treatment with Warfarin Potassium, Phenytoin, Trifluridine, Tipiracil Hydrochloride. 7) Severe complication. 8) Pregnant or lactating woman at any time during study. Men of the fertility hope. 9) Severe mental disorder. 10) Patients judged inappropriate for the study by their physicians.

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate	—

Secondary

Measure	Time frame
Relapse-free survival Disease-free survival Overall survival Local relapse-free survival Adverse events Anal sphincter preservation Anal function	—

Countries

Japan

Contacts

Public ContactSueda Toshinori

Osaka Rosai Hospital Department of Surgery

tsueda@osakah.johas.go.jp072-252-3561

Outcome results

None listed

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