UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017450
Receipt number R000020228
Scientific Title A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma
Date of disclosure of the study information 2015/05/07
Last modified on 2019/03/08 10:12:09

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Basic information

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

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

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


Assessment

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


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: 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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Japan Clinical Cancer Research Organization

Institute

Department

Personal name



Funding Source

Organization

Taiho Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

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

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 07 Day


Related information

URL releasing protocol


Publication of results

Published


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name