UMIN-CTR Clinical Trial

Public title

Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)

Acronym

Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)

Scientific Title

Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)

Scientific Title:Acronym

Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)

Region

Japan

Condition

rectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer, and to identify the more promising regimen.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

3-years Disease free survival rate

Key secondary outcomes

Pathological Effect
R0 resection rate
Completion rate of each modality(Neoadjuvant chemotherapy, Operation and Adjuvant chemotherapy)
Overall survival(OS)
Disease Free survival(DFS)
OS in patients with R0 resection
DFS in patients with R0 resection
Transition rate to Operation
local recurrence rate(per Operated population)
Safety
Pattern of first recurrence

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1 80 mg/m2 p.o. (day1-14)
L-OHP 130 mg/m2(day 1)
to be repeated every 3 week until 4 course or to meet discontinuation criteria

Interventions/Control_2

5-FU/bolus 400mg/m2 (day 1),
5-FU/continuous2,400 mg/m2 (day 1-2),
every 2 week
to be repeated every 2 week until 6 course or to meet discontinuation criteria

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Written informed consent
2) Patients who are judged to be suitable for receiving this protocol therapy by physician
3) Distal border of tumor is located under the peritoneal reflection
4)Histologically confirmed rectal adenocarcinoma
5) previously untreated rectal cancer
6) Within 28 days before registration, the tumor is considered by the surgeon to be amenable to curative resection [T category: cSS and cSE, cSI, cA, cAI. N category:cN0-2 and cN3(#253 lymph node)]
7) Within 28 days before registration, there is no evidence of distant metastasis by contrast-
enhanced CT
8) >= 20 years old
9) PS(ECOG) 0-1
10) be able to take oral drugs
11) Required baseline laboratory parameters (within 14 days before registration):
WBC >= 3000 ,<12000/mm3
Neu >= 1,500/ mm3
Hb >= 9.0g/dl
Plt >= 100,000/ mm3
T-Bil <= 2.0mg/dl
AST,ALT <= 100U/L
Cre <1.5mg/dl
Ccr >= 60mL/min
12) Considered to survive for more than 3 months.

Key exclusion criteria

1) History of serious drug hypersensitivity or a history of drug allergy
2) Pregnant or lactating woman and man who hope for Partner's pregnant
3) Active infection(over 38 degree)
4) Blood transfusion within 14 days before registration
5) Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, serious diabetes, serious hypertension)
6) Clinically significant abnormal electrocardiogram or heart disease
7) Serious diarrhea
8) Pleural effusion, peritoneal fluid that needs treatment
9) Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema )
10) Hemorrhagic diathesis, coagulation disorder
11) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less).
12) Patients who need flucytosine, phenytoin or warfarin potassium.
13) Requiring steroid drug
14) Patients with contraindication to therapy
15) History of allergy to contrast material
16) Serious stricture (exclude the patients who are put in stoma)
17) Positive for HBs antigen and HCV antibody
18) Not appropriate for the study at the physician's assessment

Target sample size

110

Name of lead principal investigator

1st name
Middle name
Last name	Yoshito Akagi

Organization

Kurume university

Division name

Surgery

Zip code

Address

67 Asahi-cho, Kurume city, 830-0011, Japan

TEL

092-631-2920

Email

sakamoto.kscc@gmail.com

Name of contact person

1st name
Middle name
Last name	KSCC

Organization

Clinical Research Support Center Kyushu

Division name

KSCC

Zip code

Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan

TEL

092-631-2920

Homepage URL

Email

sakamoto.kscc@gmail.com

Institute

Kyushu Study group of Clinical Cancer(KSCC)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

宗像医師会病院（福岡県），田川市立病院（福岡県），防府消化器病センター防府胃腸病院（山口県），医理会柿添病院（長崎県），愛知県がんセンター愛知病院（愛知県），長崎大学　移植・消化器外科（長崎県），筑後市立病院（福岡県）佐世保市立総合病院（長崎県），岡山労災病院（岡山県），伊万里有田共立病院（佐賀県），神戸市立医療センター中央市民病院（兵庫県），兵庫県立がんセンター（兵庫県），県立広島病院（広島県），済生会福岡総合病院（福岡県），久留米大学（福岡県），国立病院機構九州医療センター（福岡県），兵庫医科大学（兵庫県），製鉄記念八幡病院（福岡県），長崎大学　腫瘍外科（長崎県），熊本大学（熊本県），鹿児島厚生連病院（鹿児島県），広島赤十字・原爆病院（広島県），人吉医療センター（熊本県），中津市立中津市民病院（大分県），獨協医科大学（栃木県），松山赤十字病院（愛媛県），社会保険田川病院（福岡県），国立病院機構大分医療センター（大分県），大分大学（大分県），久留米大学医療センター（福岡県），東京医科大学（東京都），九州大学(福岡県），九州大学別府病医療センター（大分県），東邦大学医療センター大森病院（東京都），大分県立病院（大分県），岐阜大学（岐阜県），熊本市立熊本市民病院(熊本県），金沢赤十字病院（石川県），国立病院機構九州がんセンター（福岡県），田主丸中央病院(福岡県），佐世保中央病院（長崎県），公立学校共済組合九州中央病院（福岡県），潤愛会鮫島病院（鹿児島県），飯塚病院（福岡県），高野会高野病院（熊本県），済生会熊本病院（熊本県），熊本地域医療センター（熊本県），社会保険仲原病院（福岡県），国立病院機構別府医療センター（大分県），鹿児島大学（鹿児島県），福岡市民病院（福岡県），北播磨総合医療センター（兵庫県），関西労災病院（兵庫県），名古屋大学（愛知県），聖マリアンナ医科大学（神奈川県），聖マリアンナ医科大学横横浜市西部病院（神奈川県），聖マリアンナ医科大学東横病院（神奈川県），済生会八幡総合病院（福岡県），久留米総合病院（福岡県），大分赤十字病院（大分県），済生会川内病院（鹿児島県），琉球大学（沖縄県），国立病院機構名古屋医療センター（愛知県），江南厚生病院（愛知県），岡崎市民病院（愛知県），薫風会佐野病院（兵庫県），小樽掖済会病院（北海道），群馬大学（群馬県），中頭病院（沖縄県），浦添総合病院（沖縄県）, 済生会唐津病院（佐賀県），国立病院機構福岡東医療センター（福岡県），福井県済生会病院（福井県），神戸大学（兵庫県）

Date of disclosure of the study information

2013

Year

08

Month

14

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

ASCO 2017(2017/6/2~6CHICAGO,ILLINOIS in USA)
A Randomized PhaseII Study Evaluating Efficacy and Safety of SOX versus mFOLFOX6
as Neoadjuvant Chemotherapy for Patients with Resectable Rectal cancer(KSCC1301)

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

2013

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

09

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

08

Month

14

Day

Last modified on

2019

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013441