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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004647
Receipt No. R000005539
Scientific Title Phase II clinical trial of third-line Panitumumab and irinotecan or Panitumumab therapy for patients with KRAS wild-type unresectable/recurrent colorectal cancer
Date of disclosure of the study information 2010/12/01
Last modified on 2012/05/08

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Basic information
Public title Phase II clinical trial of third-line Panitumumab and irinotecan or Panitumumab therapy for patients with KRAS wild-type unresectable/recurrent colorectal cancer
Acronym SHIP trial: Short-time Infusion of Panitumumab feasibility
Scientific Title Phase II clinical trial of third-line Panitumumab and irinotecan or Panitumumab therapy for patients with KRAS wild-type unresectable/recurrent colorectal cancer
Scientific Title:Acronym SHIP trial: Short-time Infusion of Panitumumab feasibility
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of the combination regimen of Panitumumab plus irinotecan with the regimen of Panitumumab alone in patients with previously treated KRAS wild-type unresectable/recurrent colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate of Panitumumab + irinotecan regimen
Key secondary outcomes Progression-free survival, Overall survival, Time to progression, Time to progression of irinotecan combined regimen, Feasibility of Short-term Infusion of Panitumumab, Incidence of grade 2/3/4 skin toxicity during the skin treatment period

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Chemotherapy (Panitumumab + irinotecan or panitumumab)
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Unresectable advanced or recurrent colorectal cancer
2) KRAS wild-type
3) Histologically proved adenocarcinoma, mucinous carcinoma, or signet ring cell carcinoma of the colon or rectum. In the recurrent case, histology of the primary site must have been confirmed in the past. Additional histological confirmation of metastatic or recurrent site is not necessary.
4) Age: 20 to 75 years
5) ECOG performance status of 0, 1 or 2
6) Expected survival time of more than 2 months after registration
7) At least one measurable lesion based on the RECIST criterion
8) Irinotecan and fluoropyrimidine and oxaliplatin resistant or intolerable case
9) No prior anti-EGFR therapies
10) Required baseline laboratory parameters (within 7 days before registration):
Hb more than 8.0 g/dl
WBC more than 3000 and WBC less than 12000/ul
Plt more than 75,000/ul
T-Bil less than 1.5 mg/dl
GOT less than 100 IU/l
GPT less than 100 IU/l
Cre less than 1.5 mg/dl
11) Required no-therapy time from prior therapy to registration
Surgical procedure: over 4 weeks before registration
Radiation: 4 weeks
Chemotherapy: 4 weeks
12) Signed informed consent of the patient for registration
Key exclusion criteria 1) other active malignancies within 5 years
2) history of severe drug hypersensitivity
3) clinically significant infectious disease (body temperature less than 38.0 degrees)
4) severe complications (ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, hepatic failure, etc.)
5) patients who have abnormal findings on ECG and need any treatment (within 4 weeks before registration)
6) moderate/severe pleural effusion or ascites
7) symptomatic brain metastasis
8) patients who need transfusion because of GI bleeding
9) uncontrolled watery diarrhea (watery colostomy output without trouble during patient's daily living is allowed)
10) pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who do not intend to have protected intercourse
11) any other cases who are regarded as unsuitable for enrollment in the study by the investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Hamaguchi
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Akiyoshi
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email e7hjklqa@gmail.com

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization
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 山形大学医学部附属病院(山形)、石巻赤十字病院(宮城)、済生会宇都宮病院(栃木)、聖路加国際病院(東京)、東京女子医科大学(東京)、NTT東日本関東病院(東京)、都立駒込病院(東京)、東京医科歯科大学(東京)、虎ノ門病院(東京)、国立がん研究センター中央病院 (東京)、国立国際医療研究センター病院(東京)、横浜労災病院(神奈川)、横浜栄共済病院(神奈川)、昭和大学横浜市北部病院(神奈川)、富山県立中央病院(富山)、富山大学医学部附属病院(富山)、京都三菱病院(京都)、京都医療センター(京都)、新日鐵広畑病院(兵庫)、日本赤十字社長崎原爆病院(長崎)、長崎大学病院(長崎)、県立宮崎病院(宮崎)

Other administrative information
Date of disclosure of the study information
2010 Year 12 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 Completed
Date of protocol fixation
2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 01 Day
Last modified on
2012 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005539

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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