UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of TS-1 / Oxaliplatin / Radiation for KRAS mutation type locally advanced and recurrent rectal cancer.
Title of the study (Brief title)	Phase I/II study of TS-1 / Oxaliplatin / Radiation for KRAS mutation type locally advanced and recurrent rectal cancer.
Region	Japan

Condition
Condition	Advanced or recurrent rectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Phase I : To determine the maximum tolerated dose (MTD) and recommended dose (RD) of TS-1 / oxaliplatin / Radiation in patients with KRAS mutation type locally advanced and recurrent rectal cancer. Phase II : To evaluate safety and efficacy of TS-1 / oxaliplatin / Radiation in patients with KRAS mutation type locally advanced and recurrent rectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I : To determine maximum tolerated dose and recommended dose. Phese II : pCR rate.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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) will be given orally two times per day on Days 1-5, 8-12, 22-26, and 29-33. Oxaliplatin is administered intravenously at day 1 and day 22. The initial dose of Oxaliplatin was 75 mg/m2 (Level 1), given to 3 patients. The dose will be increased in a stepwise fashion, and 3 other patients will receive the next dose level until the MTD will be reached.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	31

Research contact person
Name of lead principal investigator	Masataka Ikeda, Tsunekazu Mizushima
Organization	Graduate School of Medicine, Osaka Univesity
Division name	Department of Surgery, Gastroenterolgical Surgery
Address	2-2-E2, Yamadaoka, Suita, Osaka
TEL	06-6879-3251
Email	mikeda@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Masataka Ikeda, Tsunekazu Mizushima
Organization	Graduate School of Medicine, Osaka Univesity
Division name	Department of Surgery, Gastroenterolgical Surgery
Address	2-2-E2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-3251
Homepage URL
Email	mikeda@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Osaka Univesity
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 07 Month 14 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2014 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 09 Month 07 Day
Last modified on	2016 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007466