UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000011867
Receipt number	R000013840
Scientific Title	A randomized phase II study of Regorafenib vs S-1 plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer after treatments including fluoropyrimydine, oxaliplatin, irinotecan, anti-VEGF and anti-EGFR (OGSG 1301)
Date of disclosure of the study information	2013/09/25
Last modified on	2022/11/06 00:33:55

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Basic information

Public title

A randomized phase II study of Regorafenib vs S-1 plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer after treatments including fluoropyrimydine, oxaliplatin, irinotecan, anti-VEGF and anti-EGFR (OGSG 1301)

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

colo-rectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To select better treatment method with good survival for the future control treatment after fluoro-pyrimydine, oxaliplatin, irinotecan, anti-VEGF and anti-EGFR treatments.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Progression-free survival
Response rate
Disease control rate
Time to treatment failure
Advers event

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Regorafenib is orally administered daily in one divided doses day 1 to 21 and then 7 days rest.

Interventions/Control_2

S-1is orally administered daily in two divided doses day 1 to 28 and then 14 days rest. Bevacizumab is administrated day 1, 15, 29 intravenously.
As an alternative regimen,S-1 orally administered daily in two divided doses day 1 to 14 and then 7 days rest. Bevacizumab is administrateday 1, 21 intravenously.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically proven colon cancer or rectal cancer
2) with measurable lesions for RECIST criteria version 1.1 out of the field of radiation
3) with some unresectable factors
4) older than 20 years
5) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
6) patients with colo-rectal cancer which are resistant or untolerable to fluoropyrimydine, oxaliplatin, irinotecan, anti-VEGF and anti-EGFR.
7) rest period from prior therapy
a) more than 4 weeks after surgery resecting some organs
b) more than 4 weeks after hormone therapy and/or immune-therapy
c) more than 4 weeks after cytokine or BRM therapy
d) more than 2 weeks after chemotherapy and /or radiation therapy
8) with good functions of important organs
a) WBC: 3,000/mm3<= and 12,000/mm3 >
b) Neutrophil: 1,500/mm3<=
c) Hemoglobin: 9.0 g/dl <=
d) Platelet: 100,000/mm3 <=
e) AST, ALT: within 3 times of normal range of the hospital or 5 times if patients have liver metastases
f) T.bil.: 1.5 mg/dl>
g) creatinine clearance >=50 mL/min
male:[(140-age)xB.W.(kg)]/[72x s-creatinine(mg/dl)]
female: [(140-age)xB.W.(kg)x0.85]/[72x s-creatinine(mg/dl)]
h) urine protein: <= 1+
9) with written Informed Consent

Key exclusion criteria

1)with active double cancers excluding carcinoma in situ and/or second cancer with over 5 year interval period
2) with uncontrollable diarrhea
3) with difficulty on oral intake due to intestinal paralysis or obstruction
4) with infectious disease or febrile condition
5) with HBs antigen+, HBV-DNA+ (excluding HBs Ab+ and HBV-RNA-, or HBc Ab+ and HBV-DNA-), and/or HCV-RNA+ (excluding HCV Ab+ and HCV-RNA-)
6) with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc) and/or with severe diseases (uncontrollable DM, hypertension, heart failure severer than NYHA III, renal failure and/or hepatic failure)
7) with ascites and/or pulmonary fluids which needs drainage
8) with symptoms due to brain metastasis
9) with metastatic meningitis, uncontrollable convulsion, mental disorder and/or a history of central nerve disorder
10) with a grade 2 neural disorder or mor
11) under treatment with medicine which are contra-indication to
Regorafenib, S-1 or Bevacizumab treatment or patients who are
contra-indication to Regorafenib, S-1 or Bevacizumab therapy
12) with a history of allergy to Regorafenib, S-1 or Bevacizumab
13) with a history of treatment including Regorafenib, S-1 or Bevacizumab excluding patients with longer than 6 months rest of these treatment
14) with a history of embolism, brain infarction (except Lacuna infarction) or pulmonary infarction
15) under easy bleeding condition due to some diseases or medicines (except low dose aspirin)
16) with a history of thoracic surgery or abdominal surgery within 28 days except CV reservoir
17) with active wounds
18) with a history of bloody spit more than 2.5ml
19) with a grade 2 or more CTCAEv4.0 of prior therapy
20)pregnant or nursing female or male expecting pregnancy of partner
21) Any other patients whom the physician in charge of the study judges to be unsuitable

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Motoki Yoshida

Organization

Osaka Medical College Hospital

Division name

Chemotherapy Center

Zip code

Address

2-7 Daigakucho Takatsuki City Osaka

TEL

072-683-1221

Email

ctc004@poh.osaka-med.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Motoki Yoshida

Organization

Osaka Medical College Hospital

Division name

Chemotherapy Center

Zip code

Address

2-7 Daigakucho Takatsuki City Osaka

TEL

072-683-1221

Homepage URL

Email

ctc004@poh.osaka-med.ac.jp

Sponsor or person

Institute

Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

Institute

Department

Personal name

Funding Source

Organization

Osaka Gastrointestinal Cancer Chemotherapy Study Group

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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慈泉会相澤病院、京都逓信病院(京都府)、関西電力病院(大阪府)、大阪医療センター(大阪府)、HITO病院、大阪医科大学

Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 25 Day

Related information

URL releasing protocol

http://www.pieronline.jp/content/article/0385-0684/48100/1241;jsessionid=3rcaak882eqce.x-sunmedia-li

Publication of results

Published

Result

URL related to results and publications

http://www.pieronline.jp/content/article/0385-0684/48100/1241;jsessionid=3rcaak882eqce.x-sunmedia-li

Number of participants that the trial has enrolled

Results

The median overall survival (Regorafenib(Rego) vs S-1 plus Bevacizumab(SB)) is 30.2 months vs 6.6 months [hazard ratio(HR): 0.205, p=0.123].
The median progression-free survival (Rego vs SB) is 3.7 months vs 1.6 months.
The disease control rate (Rego vs SB) is 100% vs 75%.

Results date posted

2022 Year 11 Month 05 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2021 Year 10 Month 01 Day

Baseline Characteristics

Unresectable advanced or recurrent colorectal cancer after third-line treatment

Participant flow

This study was ended prematurely due to poor accrual. Overall, 8 patients were enrolled from 6 institutions between Oct 2013 and May 2015. Although 4 patients were assigned to each group, one patient in the Rego group was excluded after enrollment.

Adverse events

Grade 3/4 adverse events
Rego: increased AST/ALT one case (25%)
hyponatremia one case (25%)
hand-foot syndrome in one case (25%)
hypertension one case (25%)
albuminuria one case (25%)
SB: enteritis

Outcome measures

Primary endpoint: overall survival
Second endpoint: progression-free survival
disease control rate

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Main results already published

Date of protocol fixation

2013 Year 07 Month 29 Day

Date of IRB

2013 Year 09 Month 02 Day

Anticipated trial start date

2013 Year 10 Month 10 Day

Last follow-up date

2016 Year 05 Month 24 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2016 Year 07 Month 25 Day

Other

Other related information

Management information

Registered date

2013 Year 09 Month 25 Day

Last modified on

2022 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=R000013840

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name