UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II trial of preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer
Title of the study (Brief title)	Preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer
Region	Japan

Condition
Condition	locally advanced rectal cancer (T3-4, N0-2, M0)
Classification by specialty	Gastroenterology Surgery in general Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safet and efficacy of preoperative chemoradiation therapy with S-1 (2 weeks administration and 1 week withdrawal) for locally advanced rectal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety (incidence and grades of adverse events for preoperative chemoradiation therapy)
Key secondary outcomes	RFS, OS, accumulated local recurrence rate, treatment completion rate, R0 resection rate, down-stagingrate, pathological response rate, response rate (RECIST version1.1), pCR, nutritional assessment, immunohistochemical assessment, safety (operative complications, late adverse events).

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	S-1: 80mg/m2/day, 2 weeks administration followed by 1 week withdrawl and 2 weeks administration, for a total of 5 weeks. Radiationa therapy: 1.8 Gy/day, 5 days/week (through Monday to Friday), a total of 45 Gy/5 weeks.
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Pathologically diagnosed as adenocarcinoma. 2) Patients who satisfy the following criteria within 28 days before registration: * Patients with tumors in T3-4 and N0-2 according to the Japanese Classification of Colorectal Carcinoma, the 2nd edition and resectable. * The tumor is mainly located in Ra, Rb or P according to the Japanese Classification of Colorectal Carcinoma, the 2nd edition. * The anal margin of the tumor is lower than the level of peritoneal inversion. * The tumor is not macroscopically classified into type 4. * Diagnosed with colonoscopy, barium enema, contrast CT and contrast MRI. If the patient is allergic to contrast, plain CT and MRI are allowed. * The distance between anal verge and the lower margin of the tumor should be recorded. 3) patients should be free from liver metastasis, peritoneal dissemination or distant metastasis. 4) Between 20 years old and 80 years old when registered. 5) Performance Status (ECOG) is 0-1. 6) No prior radiotherapy, chemotherapy or hormone therapy. 7) No severe disorder of bone marrow, heart, lung, liver or kidney. The data of blood test within 14 days before registration should be within the following range: WBC counts: 12,000/mm3 > and > 3,000 /mm3 Neutrophil counts: > 1,500 / mm3 Platelet counts: > 75,000 /mm3 Hemoglobin: > 9.0 g/dl Total bilirubin: 1.5 mg/dl > AST (GOT), ALT (GPT): 80 IU/L > Serum creatinine: 1.5 mg/dL > Creatinine clearance: > 50 ml/min (with Cockcroft-Gault's formula) 8) No clinically abnormal finding of ECG within 28 days before registration 9) Patients who can eat food and can be orally administered. 10) Informed consent has been acquired.
Key exclusion criteria	1) Patients with past history of severe drug allergy. 2) Patients with active cancers in other organs or multicentric cancers in colorectum. 3) Contraindication of S-1 administration. 4) Patients who suffered from infection with fever higher than 38 degree. 5) Patients with severe complications such as bowel obstruction, ileus, intestinal pneumonitis or pulmonary fibrosis, uncontrolled diabetes, uncontrolled hypertension, heart failure, renal failure, liver dysfunction and others. 6) Patients with past history of intestinal pneumonitis. 7) Patients with pleural or ascites retention which should be treated. 8) Patients with fresh bleeding from intestinal tract. 9) Patients with watery diarrhea. 10) Women who are willing to pregnancy or possible to be pregnant. Patients who do not intend to prevent pregnancy. 11) Patients who are continuing steroid administration orally or intravenously. 12) Patients with HBs positive. 13) Patients whom doctors consider not to be eligible for this study for some other reasons.
Target sample size	15

Research contact person
Name of lead principal investigator	Koh Miura
Organization	Miyagi Cancer Center
Division name	Department of Surgery
Address	47-1 Nodayama, Natori, Miyagi 981-1293, Japan
TEL	+81-22-384-3151
Email	kou-miura@miyagi-pho.jp

Public contact
Name of contact person	Koh Miura
Organization	Miyagi Cancer Center
Division name	Department of Surgery
Address	47-1 Nodayama, Natori, Miyagi 981-1293, Japan
TEL	+81-22-384-3151
Homepage URL
Email	kou-miura@miyagi-pho.jp

Sponsor
Institute	Department of Surgery, Miyagi Cancer Center
Institute
Department

Funding Source
Organization	None.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	None.

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	宮城県立がんセンター

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 22 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

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

Management information
Registered date	2014 Year 10 Month 26 Day
Last modified on	2018 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018039