Single-agent Panitumumab in the frail patients with wild-type RAS unresectable colorectal cancer

JRCT ID: jRCTs051180108

Registered date:08/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Colorectal Cancer
• Date of first enrollment: 09/02/2017
• Target sample size: 36
• Study type: Interventional
• Intervention(s): Panitumumab(6mg/Kg day1) therapy every two weeks

Outcome(s)

• Primary Outcome: Disease control rate
• Secondary Outcome: Response Rate: RR, Progression free survival: PFS, Overall survival: OS, Time to Treatment Failure: TTF, Safety (the rate of Grade3/4 toxicity)

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically confirmed CRC that is not a candidate for curative surgical resection
2) WT RAS
3) Patients with metastatic colorectal cancer have received no previous systemic chemotherapy.
4) Age 76 years old or older, or age 65 years old or older who were not deemed to be candidates for combination chemotherapy in the judgment of the treating investigator
5) Measurable disease according to the modified Response Evaluation Criteria In Solid Tumours(RECIST) criteria (version 1.1)
6) Adequate organ function
7) Life expectancy of at least 90 days from enrollment
8) Written informed consent prior to study-specific screening procedure
9) no previous therapy with anti EGFR anti-body

Exclude criteria

1) Uncontrolled diarrhea
2) Symptomatic interstitial pneumonia or pulmonary fibrosis
3) Previous palliative radiation therapy for bone metastasis or brain metastasis within 2 weeks
4) multiple malignancy
5) Active infections
6) Serious complications
7) History of serious anaphylaxis
8) Requires continuous treatment with systematic steroids
9) Psychiatric disability that would preclude study compliance
10)Pregnant or lactating females, and males and females unwilling to use contraception
11) HBs antigen positive
12) Otherwise determined by the investigator to be unsuitable for participation in the study

Related Information

• Primary Sponsor: GOTO Masahiro
• Secondary Sponsor: Osaka Clinical Study Supporting Organization
• Secondary ID(s): UMIN000024528