Unique ID issued by UMIN | UMIN000011348 |
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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 |
Phase II study of oxaliplatin based regimen in relapsed colon cancer patients treated with oxaliplatin based adjuvant
INSPIRE study
Phase II study of oxaliplatin based regimen in relapsed colon cancer patients treated with oxaliplatin based adjuvant
INSPIRE study
Japan |
Colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy of oxaliplatin based regimen for recurrent colorectal cancer in patients with oxaliplatin based adjuvant chemotherapy.
Efficacy
Exploratory
Pragmatic
Phase II
Progression free survival
Overall survival
Response rate
Allergy
Peripheral neuropathy
Adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Oxaliplatin
fluoropyrimidine
molecularly targeted drug
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
50
1st name | Hideyuki |
Middle name | |
Last name | Mishima |
Aichi Medical University
Cancer Center
480-1195
1-1, Yazakokarimata Nagakute, Aichi
0561-62-3311
hmishima@aichi-med-u.ac.jp
1st name | Yumi |
Middle name | |
Last name | Miyashita |
Epidemiological and Clinical research Information Network (ECRIN)
Aichi branch
444-0838
TK bldg. 6F, 1-7-9, Hanenishi Okazaki, Aichi
0564-64-7300
miya@ecrin.or.jp
Epidemiological and Clinical research Information Network (ECRIN)
Yakult Honsha Co., Ltd.
Profit organization
JAPAN
Aichi Medical University
1-1, Yazakokarimata Nagakute, Aichi
0561-62-3311
shomu@aichi-med-u.ac.jp
NO
2013 | Year | 08 | Month | 01 | Day |
Cancer Chemotherapy and Pharmacology 2021 87 665 672
Published
Cancer Chemotherapy and Pharmacology 2021 87 665 672
50
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%.
2023 | Year | 09 | Month | 20 | Day |
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.
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 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%.
The primary endpoint was the progression free survival PFS, and the secondary endpoints were the overall survival OS, response rate RR and toxicity.
Completed
2013 | Year | 07 | Month | 18 | Day |
2013 | Year | 10 | Month | 28 | Day |
2013 | Year | 11 | Month | 01 | Day |
2022 | Year | 03 | Month | 31 | Day |
2013 | Year | 08 | Month | 01 | Day |
2023 | Year | 09 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013300
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