UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014071 |
|---|---|
| Receipt number | R000016370 |
| Scientific Title | A phase II study of capecitabin plus cisplatin therapy for advanced gastric cancer with multiple lymph node metastases (OGSG 1401) |
| Date of disclosure of the study information | 2014/05/26 |
| Last modified on | 2022/09/25 16:38:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A phase II study of capecitabin plus cisplatin therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1401)
Acronym
A phase II study of capecitabin plus cisplatin therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1401)
Scientific Title
A phase II study of capecitabin plus cisplatin therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1401)
Scientific Title:Acronym
A phase II study of capecitabin plus cisplatin therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1401)
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy and safety of capecitabin plus cisplatin combined chemotherapy (XP therapy) for advanced gastric cancer with highly metastatic nodes which cannot be resected curatively
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Overall Survival (OS)
Curative operation rate
Preoperative treatment completion rate
Surgical operation completion rate
Hole treatment schedule completion rate
Histological response rate
Safety check (AE, postoperative complication)
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
It takes three weeks for a one course of Cisplatin plus capecitabin combination therapy
Standard treatment is two courses before surgical operation
Cisplatin (80 mg/m2) is administered on day 1 and day 21
Capecitabin (2000 mg/m2/day: see a conversion table) is administered daily between day 1 and day 15followed by 7 days rest, and repeat one more cycle.
If the response is immature, patients can receive two more courses before surgery.
After surgical operation, TS-1 is administered for one year.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Histologically proven gastric carcinoma by endoscopic detection
2)HER2 negative or unknown
3)With any lesion written below by upper abdominal enhanced CT:
1.Paraaortic node metastases (#16a2/16b1) larger than 10mm
2.Bulky lymph node metastases located at celiac axis, common hepatic artery, splenic artery and/or upper mesenteric vein which make a huge bulk larger than 3.0 cm and/or multiple
large bulks larger than 1.5 cm
3.Paraaortic and bulky metastatic nodes
4)Without any lesions written below by thoratic, upper abdominal and pelvic enhanced CT:
1.mediastinal node metastases
2.lung metastases
3.peritoneal metastases
4.liver metastases
5.pleural fluid and/or ascites
6.paraaortic nodes metastases (# 16a1 and/or #16b2)
7.Other distant nodes metastases and/or CY1
5) Not a large type 3 or type 4 gastric cancer
Large: the size of cancer is larger than 8 cm
6)Without esophageal invasion longer than 3 cm
7)Not a remnant gastric cancer
8)Without cervical nodes metastases and/or distant metastases
9)Age between 20 and 75 years old
10)An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
11) Without any prior chemotherapy, radiation therapy and/or hormone therapy for the gastric cancer and/or any other cancers
12)Without prior surgical therapy except EMR/ESD and/or bypass
13) Patients can take food orally with /without bypass
14) With good functions of important organs by a data taken within 2 weeks
of registration
a) WBC: =>4000/mm3
b) Neutrophil: =>1,500/mm3
c) Hemoglobin: =>8.0 g/dl without blood transfusion
d) Platelet: =>100,000/mm3
e) AST, ALT: =< 100 IU/L
f) T.bil.: =<1.5 mg/dL
g) S-cleatinine: =<1.2mg/dL
h) Creatinine clearance: =>60 ml/min/body
CC by Cockcroft-Gault method is available:=>60mL/min 15) With written Informed Consent
Key exclusion criteria
1)With active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period
2)Pregnant or nursing female
3)Male expecting pregnancy of partner
4)Impossible to register to the study due to a psychological disorder by physician in charge's decision
5)Under continuous steroids medication
6)Patients who receives systemic continuous administration of flucytosine, phenytoin or warfarin
7)With neuropathy on peripheral motor and/or sensory nerves: -> glade 2 of CTCAE v4.0
8)With interstitial pneumonitis, pulmonary fibrosis and/or severe pulmonary
emphysema
9)With active bacterial/fungal infectious disease (with a fever over 38 centigrade)
10)With a history of cardiac infarction and/or anxiety angina pectoris within 6 months
11)With uncontrollable blood hypertension
12)With uncontrollable DM
13)Any other patients whom the physician in charge of the study judges to
be unsuitable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Kimura |
Organization
Kindai University School of Medicine
Division name
Department of Surgery
Zip code
Address
377-2, Ohnohigashi , Osakasayama, Osaka, 589-8511, Japan
TEL
072-366-0221
you-kimura@surg.med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Furukawa |
Organization
Kinki University School of Medicine
Division name
Department of surgery
Zip code
Address
377-2, Onohigashi, Osakasayama, Osaka, 589-8511,Japan
TEL
072-366-0221
Homepage URL
hiroshi.furukawa@tokushukai.jp
Sponsor or person
Institute
Osaka Gastrointestinal cancer chemotherapy Study Group(OGSG)
Institute
Department
Personal name
Funding Source
Organization
Osaka Clinical Study Supporting Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
関西労災病院(兵庫県)、大阪医療センター(大阪府)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
http://www.pieronline.jp/content/article/0385-0684/47030/481;jsessionid=108u3erjag4ai.x-sunmedia-liv
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0385-0684/47030/481;jsessionid=108u3erjag4ai.x-sunmedia-liv
Number of participants that the trial has enrolled
4
Results
The study terminated after the enrollment of 4 cases.
The test was safe to conduct, but difficult to assess its efficacy.
Results date posted
| 2022 | Year | 07 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age 62 years old (56-71)
Participant flow
4 cases registered
Surgery performed in 2 cases
Adverse events
Pre-operation (G3 and above)
1 case of neutropenia
1 case of decreased hemoglobin
Perioperative period (G3 and above)
1 case of intra-abdominal abscess
1 case of pancreatic leak
Outcome measures
50% response rate (1 case of PR , 2 cases of NE)
75% of radical resection (3 cases of RO/R1, 1 case of non-excision)
25% histological response rate (1 case of GO, 1 case of G1a, 1 case of G2a, 1 case of NE)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 01 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 26 | Day |
Last modified on
| 2022 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016370
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
