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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008866
Receipt No. R000010266
Scientific Title Randomized Phase III Study of mFOLFOX7 or CAPOX plus Bevacizumab versus 5-Fluorouracil/Leucovorin or Capecitabine plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer (JCOG1018, RESPECT)
Date of disclosure of the study information 2012/09/06
Last modified on 2021/01/05

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Basic information
Public title Randomized Phase III Study of mFOLFOX7 or CAPOX plus Bevacizumab versus 5-Fluorouracil/Leucovorin or Capecitabine plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer (JCOG1018, RESPECT)
Acronym Randomized Phase III Study of mFOLFOX7 or CAPOX plus Bevacizumab versus 5-Fluorouracil/Leucovorin or Capecitabine plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer (JCOG1018, RESPECT)
Scientific Title Randomized Phase III Study of mFOLFOX7 or CAPOX plus Bevacizumab versus 5-Fluorouracil/Leucovorin or Capecitabine plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer (JCOG1018, RESPECT)
Scientific Title:Acronym Randomized Phase III Study of mFOLFOX7 or CAPOX plus Bevacizumab versus 5-Fluorouracil/Leucovorin or Capecitabine plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer (JCOG1018, RESPECT)
Region
Japan

Condition
Condition Metastatic clorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the progression-free survival (PFS) of elderly patients with metastatic colorectal carcinoma who are randomized to receive fluoropyrimidine-based therapy (5-FU/LV or capecitabine) plus bevacizumab, with or without oxaliplatin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Overall survival, Response rate, Adverse events (treatment related death, early death, grade 4 non-hematological toxicities), Quality of Life

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A: Fluoropyrimidine (5-FU/LVor capecitabine) + bevacizumab
Interventions/Control_2 B: Fluoropyrimidine (5-FU/LV or capecitabine) + oxaliplatin + bevacizumab
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pathologically proven colorectal adenocarcinoma.
2) Unresectable stage IV or reccurent colorectal cancer diagnosed by imaging.
3) Age and ECOG PS at registration fulfill either of the following conditions; (1)Age 70-74 and PS 2 (2)Age >= 75 and PS 0-2
4) No obstruction by primary tumor, which can be passed through by an endoscope.
5) No bowel obstruction due to peritoneal dissemination.
6) No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 24 weeks prior to registration.
7) Patients with either measurable or nonmeasurable disease are eligible.
8) No CNS involvement including brain metastasis
9) No prior myeloablative conditioning, whole pelvis irradiation for endometrial cacner, surgery within 12 months and chemotherapy for any malignancies.
10) Adequate organ functions.
11) Peripheral motor or sensory neuropathy =< Grade 1 defined in the CTCAE v4.0. 12) Witten informed consent.
Key exclusion criteria 1) Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shoter, except for following;; prostate cancer with clinical stage I and completely resected following cancers; gastric cancer (adenocarcinoma) with stage 0-I, colon cancer (adenocarcinoma) with stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma) with stage 0, breast cancer (noninvasive ductal carcinoma and noninvasive lobular carcinoma) with stage 0 and breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, and Paget disease) with stage 0-IIA, endometrial cancer (endometrioid adenocarcinoma and mucinous adenocarcinoma) with stage I, prostate cancer (adenocarcinoma) with stae I-II, cervical cancer (squamous cell carcinoma) with stage 0, thyroid cancer (papillary carcinoma and follicular carcinoma) with stage I-III, and renal cancer (clear cell carcinoma and chromophobe cell carcinoma) with stage I.
2) Infectious disease to be treated.
3) Body temparature >= 38c
4) Severe mental disease.
5) Currently treated with systemic steroids
6) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
7) Uncontrollable diabetes mellitus or routine administration of insulin.
8) New York Heart Association (NYHA) class III /IV cardiac disease or congestive heart failure that would take medication in order to prevent lethal ventricular arrhythmias.
9) Positive for HBsAg
10) Inadequately controlled hypertension, defined as systolic >= 150 and/or diastolic >= 100 mmHg on anti-hypertensive medications.
11) History of unstable angina, myocardial infarction, pulmonary embolism, deep vein thrombosis, cerebral hemorrhage, cerebral infarction, transient ischemic attack (TIA), cerebrovascular disturbance, or arterial thromboembolism.
12) Known hypersensitivity to any of the component of 5-FU/LV, capecitabine, oxaliplatin, or bevacizumab.
13) Inadequate characteristics for bevacizumab administration.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Shimada
Organization Kochi Health Sciences Center
Division name Division of Medical Oncology
Zip code
Address 2125-1, Ike, Kochi-shi, Kochi, Japan 781-8555
TEL 088-837-3000
Email yasuhiro_shimada@khsc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Hamaguchi
Organization JCOG1018 Coordinating Office
Division name Gastrointestinal Medical Oncology, National Cancer Center Hospital
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
TEL 03-3542-2511
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 札幌厚生病院(北海道)
岩手医科大学(岩手県)
宮城県立がんセンター(宮城県)
山形県立中央病院(山形県)
栃木県立がんセンター(栃木県)
群馬県立がんセンター(群馬県)
防衛医科大学校(埼玉県)
埼玉県立がんセンター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
順天堂大学医学部附属浦安病院(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
東京医科大学病院(東京都)
がん・感染症センター都立駒込病院(東京都)
東京医科歯科大学(東京都)
東邦大学医療センター大橋病院(東京都)
北里大学東病院(神奈川県)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
横浜市立市民病院(神奈川県)
北里大学医学部(神奈川県)
昭和大学横浜市北部病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
済生会横浜市南部病院(神奈川県)
平塚市民病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟県厚生連長岡中央綜合病院(新潟県)
富山県立中央病院(富山県)
石川県立中央病院(石川県)
長野市民病院(長野県)
岐阜大学医学部(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
藤田保健衛生大学(愛知県)
大阪大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪府立病院機構大阪府立急性期・総合医療センター(大阪府)
大阪市立総合医療センター(大阪府)
大阪医科大学(大阪府)
市立堺病院(大阪府)
箕面市立病院(大阪府)
市立吹田市民病院(大阪府)
関西労災病院(兵庫県)
兵庫医科大学(兵庫県)
医療法人薫風会佐野病院(兵庫県)
島根大学医学部(島根県)
岡山済生会総合病院(岡山県)
広島市立広島市民病院(広島県)
県立広島病院(広島県)
広島市立安佐市民病院(広島県)
福山市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)
久留米大学医学部(福岡県)
熊本大学医学部(熊本県)
大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 07 Month 24 Day
Date of IRB
2012 Year 08 Month 23 Day
Anticipated trial start date
2012 Year 09 Month 06 Day
Last follow-up date
2022 Year 03 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 09 Month 06 Day
Last modified on
2021 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010266

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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