UMIN-CTR Clinical Trial

Public title

The feasibility study of TAS-118 plus Oxaliplatin or TAS-118 monotherapy as perioperative chemotherapy for locally advanced gastric cancer

Acronym

The feasibility study of TAS-118 plus Oxaliplatin or TAS-118 monotherapy as perioperative chemotherapy for locally advanced gastric cancer (APOLLO-11)

Scientific Title

The feasibility study of TAS-118 plus Oxaliplatin or TAS-118 monotherapy as perioperative chemotherapy for locally advanced gastric cancer

Scientific Title:Acronym

The feasibility study of TAS-118 plus Oxaliplatin or TAS-118 monotherapy as perioperative chemotherapy for locally advanced gastric cancer (APOLLO-11)

Region

Japan

Condition

Resectable gastric cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess feasibility of preoperative adjuvant chemotherapy with TAS-118 plus Oxaliplatin, and postoperative adjuvant therapy with TAS-118 alone or TAS-118 plus Oxaliplatin, in patients with resectable locally advanced gastric cancer accompanying lymph node metastasis

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

-Feasibility of preoperative adjuvant chemotherapy with TAS-118 plus Oxaliplatin and gastrectomy (Step 1/2)
-Feasibility of postoperative adjuvant chemotherapy with TAS-118 alone (Step 1)
-Feasibility of postoperative adjuvant chemotherapy with TAS-118 plus Oxaliplatin (Step 2)

Key secondary outcomes

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

TAS-118/Oxaliplatin

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

79

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients satisfying all of the following criteria during baseline observation period will be considered as eligible patients in this study
(1)Be confirmed as gastric cancer histopathologically (in any of the histological types)
(2)Be diagnosed with cT3-4N1-3M0 on image findings (Japanese Classification of Gastric Carcinoma, 14th Edition)
(3)Be with swelling of stomach-regional lymph node of =>8 mm minor axis or =>10 mm major axis
(4)Be with no metastasis to Bulky lymph node on CT scanning of upper abdomen
(5)Be with no distant metastasis on diagnostic laparoscopy, and negative for peritoneal lavage cytology
(6)Be aged of 20-79 years at registration
(7)Be with no history of medical treatment to gastric cancer (radiation therapy, chemotherapy,hormone therapy, etc.)
(8)Be acceptable for sufficient oral treatment
(9)Be with ECOG performance status 0 or 1
(10)Be confirmed that major organic functions are maintained by laboratory test performed within 14 days prior registrationSatisfy the following criteria:
-WBC count: => 3000/mm3 and
<= 12000/mm3
-Neutrophil count: => 2000/mm3
-Platelet count: => 100000/mm3
-Hemoglobin: => 9.0 g/dL
-Total bilirubin: <= 1.5 mg/dL
-AST(GOT): <= 100 units/L
-ALT(GPT): <= 100 units/L
-Serum Creatinine: <= 1.3 mg/dL
-CCR: => 60 mL/min (Cockcroft-Gault estimation formula)
(11)Be explained about this clinical trial with informed consent form and submitted informed consent in writing

Key exclusion criteria

(1)Be sensitive seriously to ingredients of TAS-118 or Oxaliplatin
(2)Be received blood transfusion, blood products and hematopoietic agents such as G-CSF within 2 weeks prior to registration
(3)Be under medication with warfarin, phenytoin, flucytosine at registration
(4)Have poorly controlled diarrhea (liquid stool, difficult bowel control by medical treatment, => Grade 2, defecation frequency of => 5 times/day, etc.)
(5)Have peripheral sensory neuropathy or paraesthesia of
=> Grade 2
(6)Be with present or past history of sever pulmonary diseases
(7)Be with severe (=> Grade 3, etc.) cardiac disease, or experienced cardiac infarction and/or angina within 6 months prior to registration
(8)Be with diabetes mellitus poorly controlled by medical therapy or accompanying severe diabetic complications
(9)Be with severe (=> Grade 3, etc.) complications
(10)Be positive to HIV, or with active hepatitis
(11)Be with active infections, inflammatory diseases or collagen diseases
(12)Be requiring or receiving continuous systemic administration of steroids (oral or intravenous).
(13)Be with active (=> Grade 3, etc.) gastrointestinal hemorrhage
(14)Be with simultaneously active multiple primary cancer (simultaneous multiple cancer, and metachronous multiple primary cancers with <= 5 years disease-free period. Carcinoma in situ and lesions corresponding to intra-mucosal carcinoma judged to be cured with local therapy are not included in an active multiple cancer).
(15)Females who are pregnant, nursing and possibly pregnant, or not agree to contraception during the administration period and a certain period (6 months) after the final administration of investigational product. Females of childbearing potential must have a negative pregnancy test
(16)Be judged difficult to participate in the study due to mental disease or complicating psychiatric symptoms
(17)Be judged not to be suitable to participate in the study by principle investigator (co-investigator)

Target sample size

45

Name of lead principal investigator

1st name	Kensei
Middle name
Last name	Yamaguchi

Organization

The Cancer Institute Hospital of JFCR

Division name

Gastroenterology Center Gastroenterology medical oncology

Zip code

135-8550

Address

3-8-31 Ariake Koto-ku Tokyo

TEL

03-3520-0111

Email

kensei.yamaguchi@jfcr.or.jp

Name of contact person

1st name	Daisuke
Middle name
Last name	Takahari

Organization

The Cancer Institute Hospital of JFCR

Division name

Gastroenterology Center Gastroenterology medical oncology

Zip code

135-8550

Address

3-8-31 Ariake Koto-ku Tokyo

TEL

03-3520-0111

Homepage URL

Email

daisuke.takahari@jfcr.or.jp

Institute

The Cancer Institute Hospital of JFCR

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)

Yakult Honsha Co.,Ltd.

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

Secondary IDs

YES

Study ID_1

TAS-118:28-3587 Oxaliplatin(L-OHP):28-3588

Org. issuing International ID_1

MHLW

Study ID_2

Org. issuing International ID_2

IND to MHLW

TAS-118:2016/11/01 (5) Oxaliplatin:2016/11/01 (15)

Institutions

がん研究会有明病院、国立がん研究センター中央病院、聖マリアンナ医科大学病院

Date of disclosure of the study information

2016

Year

11

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

2016

Year

08

Month

24

Day

Date of IRB

2016

Year

09

Month

17

Day

Anticipated trial start date

2016

Year

11

Month

18

Day

Last follow-up date

2020

Year

06

Month

23

Day

Date of closure to data entry

Date trial data considered complete

2020

Year

07

Month

02

Day

Date analysis concluded

Other related information

Registered date

2016

Year

11

Month

02

Day

Last modified on

2020

Year

11

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028403