UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011457 |
|---|---|
| Receipt number | 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 15:27:50 |
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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
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
tkonishi-tky@umin.ac.jp
Sponsor or person
Institute
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013413
