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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011457
Receipt No. R000013413
Scientific Title Phase II trial of induction mFOLFOX6 plus Avastin followed by neoaduvant chemoradiotherapy with TS-1 for MRI-defined high-risk rectal cancer (IMPACT-RC)
Date of disclosure of the study information 2013/08/11
Last modified on 2019/07/08

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Basic information
Public title Phase II trial of induction mFOLFOX6 plus Avastin followed by neoaduvant chemoradiotherapy with TS-1 for MRI-defined high-risk rectal cancer (IMPACT-RC)
Acronym Phase II trial of induction mFOLFOX6 plus Avastin followed by neoadjuvant chemoradiotherapy with TS-1 for high-risk rectal cancer
Scientific Title Phase II trial of induction mFOLFOX6 plus Avastin followed by neoaduvant chemoradiotherapy with TS-1 for MRI-defined high-risk rectal cancer (IMPACT-RC)
Scientific Title:Acronym Phase II trial of induction mFOLFOX6 plus Avastin followed by neoadjuvant chemoradiotherapy with TS-1 for high-risk rectal cancer
Region
Japan

Condition
Condition Resectable locally advanced rectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Radiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of induction mFOLFOX6 plus bevacizumab followed by neoaduvant chemoradiotherapy with S-1 for MRI-defined high-risk rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes pCR rate
Key secondary outcomes Safety (proportion of adverse events and morbidity), R0 resection rate, Response rate, Proportion of clinical downstaging, Three-year recurrence free survival, Proportion of gastrointestinal perforation during the treatment

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 Preoperative administration of six courses mFOLFOX6 + bevacizumab (5mg) followed by 50.4Gy chemoradiation (1.8Gy x28) with S-1 (80-120mg daily on days 1-14 and 22-35)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Rectal adenocarcinoma diagnosed pathologically at the Department of Pathology, Cancer Institute Hospital, Tokyo, Japan.
2) Patients with MRI and CT-defined locally advanced rectal cancer who meet either of the following clinical criteria.
* Lateral lymph node metastasis and/or 4 or more mesorectal lymph node metastases (N2-3 as defined by the 7th edition of the Japanese Classification of Colorectal Carcinoma).
* Lymph node metastasis along the proximal superior mesenteric artery (N2-3 as defined by the 6th edition of the Japanese Classification of Colorectal Carcinoma).
* Tumors extending to within 1 mm of or beyond the mesorectal fascia (ie, CRM involved or threatened).
* T3 low-lying tumors at or below the levators or T4 tumors invading to the levators (ie, abdominoperineal resection needed for R0 resection).
* T4 tumors invading to surrounding structures or peritoneum.
* Tumors extending 5 mm or more into perirectal fat.
3) Lower edge of tumors located at or below the lower edge of the second sacrum (Ra/Rb rectal cancer as defined by the 7th edition of the Japanese Classification of Colorectal Carcinoma).
4) R0 resection is possible before treatment.
5) No distant metastasis.
6) Performance Status (ECOG) 0 or 1.
7) No preceding preoperative radiotherapy, chemotherapy or hormonal therapies.
8) Function of major organs is well-preserved, including bone marrow, heart, lung and kidney.
9) Oral administration is possible.
10) Written informed consent is obtained.
Key exclusion criteria 1) Contraindication for either of S-1, Oxaliplatin, 5-FU, Leucovorin or Bevasizumab
2) Past history of severe hypersensitivity to the drugs
3) Past history of irradiation to the pelvis
4) Presence of infection with fever
5) Presence of severe morbidity such as heart failure, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, renal failure and liver failure.
6) Presence of sensory neuropathy
7) Presence or clinical manifestation of brain metastasis
8) Presence of diarrhea daily
9) Presence of ascites and/or pleural effusion which need aspiration
10) Presence of concomitant malignancy or past history of malignancy within five years
11) Female with pregnancy
12) Male who desire to keep fertility
13) Other inappropriate cases judged by doctors
Target sample size 43

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Konishi
Organization The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name Gastroenterological Surgery
Zip code 1358550
Address 3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL 03-3520-0111
Email tkonishi-tky@umin.ac.jp

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Konishi
Organization The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name Gastroenterological Surgery
Zip code 1358550
Address 3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL 03-3520-0111
Homepage URL
Email tkonishi-tky@umin.ac.jp

Sponsor
Institute The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization Takeda Science Foundation
Sumitomo Mitsui Banking Corporation
Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address Ariake 3-8-31, Koto-ku, Tokyo 135-8550, Japan
Tel 03-3520-0111
Email naomasa.yamanojyo@jfcr.or.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 11 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 76
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 Completed
Date of protocol fixation
2012 Year 11 Month 05 Day
Date of IRB
2012 Year 11 Month 08 Day
Anticipated trial start date
2012 Year 11 Month 14 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recruiting of patients for the primary endpoint (pCR) has finished (n=43).
Now we are recruiting patients for additional research of revealing proportion of GI perforatoin during the treatment as a secondary endpoint (n=78).

Management information
Registered date
2013 Year 08 Month 11 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013413

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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