Phase2 study of limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy

Phase2 study of limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy - Limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007184

Enrollment

Registered

2012-03-01

Start date

2012-03-01

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

S-1 (80 mg/m2/d) 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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Main part of the tumor is located in P-Rb. 2) Previously untreated locally advanced lower rectal cancer with preoperative diagnosis of T1/2 and N0-3 and M0. 3) Tumor diameter=< 30mm 4) Well differentiated adenocarcinoma or Moderately differentiated adenocarcinoma 5) Has at least one of the following factors i. Invaded the submucosa (SM)>= 1000um or muscularis propria (MP). ii. Has venous or lympho-vessel invasion iii. Tumor budding Grade2/3 6) Negative surgical margin 7) No prior therapy expect the operation. 8) No severe complications 9) Age :> =65 years 10) Performance status (ECOG) of 0-1 11) Capability of oral intake 12) Patients who have satisfied the following the clinical test values within two weeks before the registration. i. WBC: 3,000-12,000 /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: >= 40 ml/min 13) 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 fluorocytosine. 6) Severe complication. 7) Pregnant or lactating woman at any time during study. Men of the fertility hope. 8) Severe mental disorder. 9) Patients judged inappropriate for the study by their physicians.

Design outcomes

Primary

Measure	Time frame
Relapse-free survival	—

Secondary

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

Countries

Japan

Contacts

Public ContactNorikatsu Miyoshi

Osaka University Graduate School of Medicine Department of Gastroenterological Surgery

nmiyoshi@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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