UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011348
Receipt number R000013300
Scientific Title Phase II study of oxaliplatin based regimen in relapsed colon cancer patients treated with oxaliplatin based adjuvant
Date of disclosure of the study information 2013/08/01
Last modified on 2023/09/20 23:23:59

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Basic information

Public title

Phase II study of oxaliplatin based regimen in relapsed colon cancer patients treated with oxaliplatin based adjuvant

Acronym

INSPIRE study

Scientific Title

Phase II study of oxaliplatin based regimen in relapsed colon cancer patients treated with oxaliplatin based adjuvant

Scientific Title:Acronym

INSPIRE study

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of oxaliplatin based regimen for recurrent colorectal cancer in patients with oxaliplatin based adjuvant chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival
Response rate
Allergy
Peripheral neuropathy
Adverse event


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

Oxaliplatin
fluoropyrimidine
molecularly targeted drug

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Stage II, III colon cancer patients treated with oxaliplatin based adjuvant chemotherapy.
2) Recurrence after more than 6 months post adjuvant chemotherapy
3) Peripheral neuropathy<=grade1
4) Cumulative dose of oxaliplatin >=more than 300 mg/m2 as adjuvant therapy
5) Measurable lesion by RECIST1.1
6) Age of 20 years or older
7) ECOG Performance status(PS) of 0-1
8) A life expectancy of more than 12 week.
9) No severe impairment of major organs (bone marrow, heart, lungs, liver, kidneys, etc.),
laboratory data within 14 days

WBC <=12,000mm3
neutrophil >=1,500/mm3
hemoglobin >=8.0g/dL
platelet >=100,000/mm3
AST and ALT
<=2.5 ULN or <=5.0 ULN if the patient has liver metastasis
T-Bil <=1.5 ULN
Cr <=UNL
Creatinine clearance >=50 mL/min
10)Written informed consent.

Key exclusion criteria

1) Serious drug allergy.
2) Serious sensory abnormality or dysfunction
3) Presence of other active malignancies or a history of malignancies within the past 5 years
4) blood transfusion or hemopoietic factors (e.g. G-CSF) within 7 days .
5) Uncontrolled pleural effusion, ascites, or pericardial effusion.
6) Clinically significant infection.
7) brain metastasis
8) Clinically significant heart disease (myocardial infarction within 12 months, etc.).
9) Serious complication(intestinal obstruction, interstitial pneumonia, uncontrolled diabetes, peptic ulcer hypertension, renal failure, hepatic failure )
10) fresh GI bleeding
11) Watery diarrhea
12) Central nervous system disorders
13) Dementia or clinically significant mental/neurological disorders.
14)Women who are pregnant, lactating, or wish to become pregnant.
15) Investigator's judgement.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hideyuki
Middle name
Last name Mishima

Organization

Aichi Medical University

Division name

Cancer Center

Zip code

480-1195

Address

1-1, Yazakokarimata Nagakute, Aichi

TEL

0561-62-3311

Email

hmishima@aichi-med-u.ac.jp


Public contact

Name of contact person

1st name Yumi
Middle name
Last name Miyashita

Organization

Epidemiological and Clinical research Information Network (ECRIN)

Division name

Aichi branch

Zip code

444-0838

Address

TK bldg. 6F, 1-7-9, Hanenishi Okazaki, Aichi

TEL

0564-64-7300

Homepage URL


Email

miya@ecrin.or.jp


Sponsor or person

Institute

Epidemiological and Clinical research Information Network (ECRIN)

Institute

Department

Personal name



Funding Source

Organization

Yakult Honsha Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Aichi Medical University

Address

1-1, Yazakokarimata Nagakute, Aichi

Tel

0561-62-3311

Email

shomu@aichi-med-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 01 Day


Related information

URL releasing protocol

Cancer Chemotherapy and Pharmacology 2021 87 665 672

Publication of results

Published


Result

URL related to results and publications

Cancer Chemotherapy and Pharmacology 2021 87 665 672

Number of participants that the trial has enrolled

50

Results

The median PFS was 11.5 months 95% confidence interval CI 8.3 16.0, the median OS was 45.4 months 95% CI 37.4 NA, and the RR was 56.0% 95% CI 42.3 68.8. Adverse events of grade 3 that occurred in 5% of cases were neutropenia in 6 patients 12%, peripheral sensory neuropathy in 5 patients 10%, diarrhea in 4 patients 8%, hypertension in 4 patients 8%, anorexia in 3 patients 6% and allergic reactions in 3 patients 6%.

Results date posted

2023 Year 09 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Stage II III colon cancer patients with neuropathies of grade 1 who relapsed more than 6 months after adjuvant chemotherapy including OX were considered eligible.

Participant flow

Eligible patients were treated with 5fluorouracil, lleucovorin and OX plus molecularly targeted agents or capecitabine and OX plus bevacizumab BV or S-1 and OX plus BV.

Adverse events

Adverse events of grade 3 that occurred in 5% of cases were neutropenia in 6 patients 12%, peripheral sensory neuropathy in 5 patients 10%, diarrhea in 4 patients 8%, hypertension in 4 patients 8%, anorexia in 3 patients 6% and allergic reactions in 3 patients 6%.

Outcome measures

The primary endpoint was the progression free survival PFS, and the secondary endpoints were the overall survival OS, response rate RR and toxicity.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 07 Month 18 Day

Date of IRB

2013 Year 10 Month 28 Day

Anticipated trial start date

2013 Year 11 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 08 Month 01 Day

Last modified on

2023 Year 09 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013300


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name