UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004647 |
|---|---|
| Receipt number | 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 16:19:40 |
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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
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
e7hjklqa@gmail.com
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005539
