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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023148
Receipt No. R000026662
Scientific Title A phase Ib/II, multicenter study to investigate the safety, efficacy, and proof-of-concept (POC) of nivolumab monotherapy as a sequential therapy following preoperative chemoradiotherapy in patients with locally advanced resectable rectal cancer
Date of disclosure of the study information 2016/09/01
Last modified on 2021/07/16

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Basic information
Public title A phase Ib/II, multicenter study to investigate the safety, efficacy, and proof-of-concept (POC) of nivolumab monotherapy as a sequential therapy following preoperative chemoradiotherapy in patients with locally advanced resectable rectal cancer
Acronym nivolumab following preoperative chemoradiotherapy in patients with resectable rectal cancer (VOLTAGE)
Scientific Title A phase Ib/II, multicenter study to investigate the safety, efficacy, and proof-of-concept (POC) of nivolumab monotherapy as a sequential therapy following preoperative chemoradiotherapy in patients with locally advanced resectable rectal cancer
Scientific Title:Acronym nivolumab following preoperative chemoradiotherapy in patients with resectable rectal cancer (VOLTAGE)
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety, efficacy, and proof-of-concept (POC) of immune checkpoint inhibitors and surgical treatment as sequential treatment for patients with primary, local recurrence, or resectable lung and liver metastases after preoperative chemoradiotherapy(CRT) using capecitabine.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Pathological complete response (pCR) rate
Key secondary outcomes - Objective Response rate(ORR)
- Mode of recurrence
- Disease-free survival(DFS)
- Overall survival (OS)
- Adverse event (AE)
- Rate of completing the protocol therapy
Rate of radical resection for patients with primary resectable rectal cancer
- Macroscopic evaluation of the resected specimen of primary rectal cancer
- Intraoperative safety evaluation
- Postoperative safety evaluation

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 After preoperative chemoradiotherapy, nivolumab(240mg) or nivolumab(240mg) plus ipilimumab (3 mg/kg) will be administered, and then radical surgery will be performed.
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria -Phase 1b part and the cohort A,D:primary rectal cncer
1. Treatment-naive patients with rectal cancer, located within 12cm from their anal verge
2. Clinical stage of T3-4 N-any M0
3. Age of >= 20 to < 80 years

-The cohort B:local recurrence rectal cancer
1. Clinically diagnosed recurrent rectal cancer in the pelvis
2. The tumor is thought to be resectable by the imaging before CRT
3. Age of >= 20 to =< 75 years

-The cohort C:First rectal cncer wirh resectable lung or liver metastases
1. Treatment-naive patients with rectal cancer, located within 12cm from their anal verge.
2. Clinical stage of T3-4 N-any M1a
3. Metastatic liver or lung tumors have been diagnosed clinically resectable
4. Age of >= 20 to < 80 years

-Common criteria:
1. ECOG PS of 0 or 1
2. 50.4 Gy of concurrent pre-CRT completed with daily 1,650 mg/m2 of capecitabine
3. CRT-associated AEs will be recovered to grade =< 1 when study treatment starts
4. Sufficient organ functions

Key exclusion criteria 1.Active multiple cancers .
2.Pts with a history of pelvic radiation.
3.Pts with a history of inflammatory bowel disease.
4.Pts with a history of pneumonitis or ILD.
5.Pts with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.
6.Pts requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study.
7.Pts with a history of thyroid dysfunction.
8.Pts with a history or finding of cardiovascular risk falling into any of the following:
・left ventricular ejection rate below 50percent EF.
・history or finding of clinically significant, poorly controlled arrhythmia; exception: patients with well-controlled atrial fibrillation for more than 30 days before enrollment may be enrolled.
・history of acute coronary syndrome, coronary angioplasty, or stent placement within 6 months before enrollment.
・history or class II or more severe congestive heart failure according to NYHA .
・treatment-resistant hypertension.SP>140,DBP>90mmHG
・Pts wearing an implantable cardioverter defibrillator or permanent pacemaker.
9.Pts with poorly controlled diabetes mellitus or other diseases possibly interfering with toxicity evaluation.
10.Pts who are positive for any of the following: HIV-1and2 antibody,HTLV-1 antibody, HBs antigen,HCV antibody test.
HBV-DNA above detection sensitivity will be also excluded.
11.Pts who are pregnant or lactating or who may be pregnant.
12.Pts with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study.
13.history of treatment with nivolumab.
14.Pts who are not willing to or incapable of complying with the procedures specified in the protocol.
15.Pts cannot agree ICF.
16.Pts who are determined by the investigator to be unsuitable as a subject for the study.





Target sample size 90

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Yoshino
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email voltage_core@east.ncc.go.jp

Public contact
Name of contact person
1st name Yuichiro
Middle name
Last name Tsukada
Organization National Cancer Center Hospital East
Division name Division of Colorectal Surgery
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email voltage_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center
Hospital East
Institute
Department

Funding Source
Organization ONO pharmaceutical CO.,LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Project of Translational and Clinical Research Core Centers
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board in national cancer centre
Address 6-5-1,Kashiwanoha,Kashiwa,Chiba,Japan
Tel 04-7133-1111
Email irboffice@east.ncc.go.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 国立研究開発法人国立がん研究センター東病院(千葉県)
北海道大学病院(北海道)
独立行政法人国立病院機構 大阪医療センター(大阪府)
愛知県がんセンター(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 25 Day
Date of IRB
2016 Year 09 Month 07 Day
Anticipated trial start date
2016 Year 09 Month 25 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 13 Day
Last modified on
2021 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026662

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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