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

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 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

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

Value
https://center6.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