UMIN-CTR Clinical Trial

Public title

A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma

Acronym

JACCRO CC-04 (SHOGUN trial)

Scientific Title

A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma

Scientific Title:Acronym

JACCRO CC-04 (SHOGUN trial)

Region

Japan

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology	Gastrointestinal surgery	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study.
The purpose of this study is as follows,
In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD).
In phase II, to evaluate the antitumor effect (pCR rate) and the safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

Phase I: to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD)
Phase II: pCR rate

Key secondary outcomes

Phase I: pCR rate, R0 resection rate, Down staging rate, Safety
Phase II: R0 resection rate, Down staging rate, Local reccurence rate, Disease free survuval, Safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1: 40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.
Oxaliplatin: 40-60mg/m2/week intravenously on day 1, 8, 22 and 29.
Radiation: Total dose is 50.4Gy (1.8Gy X 28 fractions)

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) The primary tumor is located in the upper rectum above the peritoneal reflection (Ra) or in the lower rectum below the peritoneal reflection (Rb).
2) The main histological type is confirmed to be adenocarcinoma (tub1/tub2).
3) A preoperatively diagnosis of T3 or T4 (any N) tumors on multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI) (UICC TNM classification, 7th edition, 2009) .
4) R0 resection is considered feasible.
5) No distant metastasis.
6) Age at the time of obtaining informed consent.
Phase I study: 20 years or older to 75 years or younger
Phase II study: 20 years or older to 80 years or younger
7) A performance status (Eastern Cooperative Oncology Group, ECOG) of 0 or 1
8) No previous treatment with radiotherapy, chemotherapy, or hormonal therapy.
9) Adequate main organ functions on the basis of data obtained within 14 days before enrollment (examinations performed on the same day of the week 2 weeks before enrollment acceptable) as follows:
i) White-cell count >= 4000 /mm3 and <= 12,000/mm3
ii) Neutrophil count >= 2000 /mm3
iii) Platelet count >= 10.0 X 104 /mm3
iv) Hemoglobin >= 9.0 g/dL
v) AST (GOT) <= 100 IU/L
vi) ALT (GPT) <= 100 IU/L
vii) Serum bilirubin <= 1.5 mg/dL
viii) Creatinine clearance <= 60.0 mL/min*
If creatinine clearance is measured by 24-hour urine collection, that value will be used. If a measured value is unavailable, the estimated creatinine clearance rate will be calculated by using the following Cockcroft-Gault formula.
Males: creatinine clearance = body weight X (140; age)/(72 X serum creatinine level)
Females: creatinine clearance = 0.85 X {body weight X (140; age)/(72 X serum creatinine level)}
10) The ability to orally ingest food and receive drugs.
11) Written informed consent to participate in the study obtained directly from the patient.

Key exclusion criteria

1) A previous history of serious drug-induced hypersensitivity.
2) A history of radiotherapy of the pelvic cavity.
3) Infection accompanied by a fever of 38.0 degrees C or higher
4) Serious concurrent disease (interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver failure, etc.).
5) Remarkable electrocardiographic abnormalities or clinically problematic heart disease (heart failure, myocardial infarction, angina pectoris).
6) Sensory neuropathy.
7) Serious diarrhea (watery stool) (however, excluding diarrhea occurring as a defecatory abnormality caused by colorectal cancer).
8) Pleural effusion or ascites that may require puncture to alleviate symptoms.
9) Synchronous multiple primary cancer or metachronous multiple primary cancer with a disease-free survival of 5 years or less (However, patients with early cancer likely to be cured by local treatment will not be excluded.).
10) Women who may (want to) become pregnant, pregnant women, or breast-feeding women.
11) Men who want to have children.
12) Current treatment with flucytosine.
13) In addition, patients who are judged by the responsible study investigator or physician in charge to be inappropriate for enrollment in the study.

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Toshiaki Watanabe

Organization

The University of Tokyo

Division name

Department of Surgical Oncology and Vascular Surgery

Zip code

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo 1130033, Japan

TEL

03-3815-5411

Email

toshwatanabe@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Masashi Fujii

Organization

Japan Clinical Cancer Research Organization

Division name

Office

Zip code

Address

1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan

TEL

03-5579-9882

Homepage URL

Email

cc04.dc@jaccro.or.jp

Institute

Japan Clinical Cancer Research Organization

Institute

Department

Personal name

Organization

Taiho Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

ClinicalTrials.gov Identifier:NCT01227239

Org. issuing International ID_1

ClinicalTrials.gov Identifier:NCT01227239

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

05

Month

07

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2010

Year

02

Month

27

Day

Date of IRB

Anticipated trial start date

2010

Year

09

Month

01

Day

Last follow-up date

2016

Year

08

Month

31

Day

Date of closure to data entry

2016

Year

09

Month

30

Day

Date trial data considered complete

2016

Year

10

Month

31

Day

Date analysis concluded

2016

Year

12

Month

31

Day

Other related information

Registered date

2015

Year

05

Month

07

Day

Last modified on

2019

Year

03

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020228