Phase I/II study of TS-1 / Oxaliplatin / Radiation for KRAS mutation type locally advanced and recurrent rectal cancer.

Phase I/II study of TS-1 / Oxaliplatin / Radiation for KRAS mutation type locally advanced and recurrent rectal cancer. - Phase I/II study of TS-1 / Oxaliplatin / Radiation for KRAS mutation type locally advanced and recurrent rectal cancer.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006305

Enrollment

Registered

2011-10-01

Start date

2011-10-01

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

Advanced or recurrent rectal cancer

Interventions

Radiotherapy with two parallel opposed lateral fields will be administered in fractions of 1.8 Gy/day, given 5 days per week for 25 days. The total dose of radiation will be 45 Gy. TS-1 (80-120mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histopathological confirmation of rectal cancer. 2)Locally advanced or recurrent cancer. 3) KRAS mutation type (codon12,13). 4) Previous chemotherapy completed at least 4 weeks before inclusion. 5) >=Age 20 6) ECOG performance status of 0 to 1. 7) Expected more than 3 months survival. 8) Sufficient function of important organs 1.Leu:4,000/mm3 to 12,000/mm3 2.Neu : >= 2,000 /mm3 3.Platelet : >= 100,000 /mm3 4.hemoglobin : >= 9.0 g/dL 5.AST, ALT : < 100 IU/L (<150 IU/L in case of liver metastasis) 6.St.bil : < 2.0 mg/dL 7.Ccr : >= 60 ml/min 9) Ability to ingestion intake and drug administration orally. 10) Informed consent is obtained.

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ. 2) No radiation therapy 3) Allergic to a drug 4) Patients under treatment with flucytosine. 5) Sensory neuropathy 6) Metastasis to CNS. 7) Intestinal paralysis or ileus 8) Massive pleural or abdominal effusion. 9) Active infection and inflammation. 10) Watery stools or diarrhea. 11) Severe complications 12) Pregnant or lactating 13) Other patients who are unfit for the study as determined by the attending physician.

Design outcomes

Primary

Measure	Time frame
Phase I : To determine maximum tolerated dose and recommended dose. Phese II : pCR rate.	—

Countries

Japan

Contacts

Public ContactMasataka Ikeda, Tsunekazu Mizushima

Graduate School of Medicine, Osaka Univesity Department of Surgery, Gastroenterolgical Surgery

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

Outcome results

None listed

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