UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015065
Receipt number R000017528
Scientific Title Evaluation for effects on anticancer efficacy and patient's QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer
Date of disclosure of the study information 2014/09/05
Last modified on 2014/09/05 11:47:42

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Basic information

Public title

Evaluation for effects on anticancer efficacy and patient's QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer

Acronym

Evaluation for effects from dosage adjustment caused by skin toxicity in Panitumumab treatment for metastatic colorectal cancer

Scientific Title

Evaluation for effects on anticancer efficacy and patient's QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer

Scientific Title:Acronym

Evaluation for effects from dosage adjustment caused by skin toxicity in Panitumumab treatment for metastatic colorectal cancer

Region

Japan


Condition

Condition

Metastatic Colorectal Cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of dose adjustment based on original self-check sheet for skin toxicity in the standard chemotherapy with panitumumab for the patients with unresectable metastatic colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

Quality of life of the patient, response rate, total dosage and duration of Panitumumab


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

mFOLFOX6+Panitumumab therapy is performed until PD. And dosage of Panitumumab is adjusted according to skin toxicity measured by self-check sheet before each therapy.
Oxaliplatin 85mg/m2
5FU 400mg/m2 bolus, 2400mg/m2 continuous drip
Levofolinate 200mg/m2
Panitumumab 6mg/kg

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

1. Histologically proved colorectal cancer (adenocarcinoma)
2. Unresectable advanced or recurrent colorectal cancer
3. KRAS wild type
4. Anticancer drug-naive when consent gained
5. ECOG performance status of 0-2
6. Measureable region evaluable according to the RECIST of CT or MRI
7. Life expectancy of at least 2 months
8. Major organ function within 2 weeks of enrollment have met the following criteria.
(1) WBC >= 3,000/mm3 and WBC < 12,000/mm3
(2) Neutrophil >= 1,500/mm3
(3) Platelet >= 100,000/mm3
(4) Hemoglobin concentration >= 8.0g/dL
(5) AST and ALT <= 100IU/L
(6) Total bilirubin <= 2.0mg/dL
(7) Ccr >= 50mL/min or serum creatinine < 1.2mg/dL
Without measurement to use Cockcroft-Gault Ccr=[(140-age)*body weight]/(72*serum creatinine)(if female *0.85)
9. Written consent of the patient has been obtained

Key exclusion criteria

1. Presence of severe drug allergy
2. Administration contraindication of using drugs
3. Antiplatelet or anticoagulant cannot be discontinued
4. Active infectious disease causing fever more than 38 deg C
5. Active gastrointestinal bleeding
6. Serious comorbidities (ileus, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, severe renal failure and liver failure etc.)
7. Pleural effusion or ascites that drainage is needed for
8. Other active malignancies those DFS is within 5 years (except for carcinoma in situ that was confirmed cured by local treatment)
9. Women of childbearing potential, women in pregnancy or lactation and patients who have desire to bear children
10. Investigator deems inappropriate to participate in the test

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyasu Iwasaki

Organization

Gifu Prefectual Tajimi Hospital

Division name

gastroenterology

Zip code


Address

5-161, Mehatacho, Tajimi City, Gifu Prefecture, 507-8522, Japan

TEL

0572-22-5311

Email

iwasaki-hiroyasu@tajimi-hospital.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyasu Iwasaki

Organization

Gifu Prefectual Tajimi Hospital

Division name

gastroenterology

Zip code


Address

5-161, Mehatacho, Tajimi City, Gifu Prefecture, 507-8522, Japan

TEL

0572-22-5311

Homepage URL


Email

iwasaki-hiroyasu@tajimi-hospital.jp


Sponsor or person

Institute

Gifu Prefectual Tajimi Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

岐阜県立多治見病院(岐阜県)


Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 05 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

2014 Year 04 Month 08 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 16 Day

Last follow-up date


Date of closure to data entry

2016 Year 07 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 05 Day

Last modified on

2014 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017528


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name