A phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical stage II/III squamous cell carcinoma of the anal canal (JCOG0903, SMART-AC)

A phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical stage II/III squamous cell carcinoma of the anal canal (JCOG0903, SMART-AC) - A phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical stage II/III squamous cell carcinoma of the anal canal (JCOG0903, SMART-AC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003237

Enrollment

Registered

2010-02-23

Start date

2010-02-23

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

anal canal caner

Interventions

Combination chemoradiotherapy consists of S-1(day1-14, 29-42, 40-80mg/m2/day), MMC(day1,29, 10mg/m2), and radiotherapy(59.4Gy/33Fr)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Lesion located in anal canal 2) Histologically proven squamous cell carcinoma or basaloid carcinoma 3) Clinical stage II or III (TNM-UICC 6th, 2002) 4) Phase I part: aged 20 to 75 years old, phase II part: aged 20 to 80 years old 5) ECOG Performance status 0 or 1 6) Both measurable lesions and unmeasurable lesions 7) No previous therapy against anal canal cancer 8) Neither previous chemotherapy, chemoradiotherapy, nor radiotherapy against any cancer 9) Sufficient oral intake 10) Adequate organ functions 11) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy 2) Patients requiring the administration of phenytoin or warfarin potassium 3) Pregnant or lactating women or women of childbearing potential 4) Psychosis 5) Patients requiring systemic steroids medication 6) Serum HBs antigen positive 7) Anti-HIV antibody positive 8) Uncontrollable diabetes mellitus or administration of insulin. 9) Uncontrollable hypertention 10) Unstable angina, heart failure, or with a history of myocardial infarction within 6 months. 11) Interstitial pneumonia, fibroid lung, or severe emphysema 12) Active bacterial or fungous infection 13) fever over 38 degrees centigrade

Design outcomes

Primary

Measure	Time frame
Phase I: Incidence of dose limiting toxicity Phase II: Proportion of 3 year event-free survival	—

Secondary

Measure	Time frame
Phase I: Incidence of adverse events Phase II: Complete response rate, progression-free survival, event-free survival, over all survival, colostomy-free survival, incidence of adverse events, and febril neutropenia	—

Countries

Japan

Contacts

Public ContactYoshinori Ito

JCOG0903 Coordinating Office National Cnacer Center Hosipital, division of radiation oncology

JCOG_sir@ml.jcog.jp03-3542-2511

Outcome results

None listed

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