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Completed

NCT Number: NCT03698253

Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

The survey is a retrospective study to evaluate the prognotic value of EGFR expression, KRAS mutations and tumor sideness in patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, 807, Taiwan

About this study

Primary objective:

Progression-free survival

Secondary objecive:

Overall survival, best objective response, disease control rate and adverse events

Number of Subjects: 41 patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.

Plan of the Study:

  • This is a retrospective study.
  • Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.
  • Duration of Treatment: Treatment was administered until disease progressed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 20-85 years old
  • Histologically proven metastatic colorectal cancer (mCRC).
  • Patients with progressing mCRC who were previously treated with FOLFOX, FOLFIRI, anti-VGFR monoclonal antibody (MoAb), and anti-EGFR MoAb if KRAS-wild-type tumors were identified.
  • Patient was able to understand the requirements of the study and written informed consent was obtained from each subject.

Exclusion criteria

  • Patients who do not meet the including criteria or unwilling to participate

Treatment and study plan

regorafenib

Drug

Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle

Other names: stivarga

UGT1A1 genotyping (TA6/TA6)

Genetic

The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2

UGT1A1 genotyping (TA6/TA7)

Genetic

The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2

UGT1A1 genotyping (TA7/TA7)

Genetic

The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2

Primary outcomes

  1. Progression-free survival

    Time frame: From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months

    Time from treatment to disease progresses

Secondary outcomes

  1. Overall survival

    Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 23 months

    Time from treatment to death of subjectives

  2. Best objective response

    Time frame: From date of initiation of treatment until the date of disease progression, assessed up to 23 months

    best response recorded during treatment

  3. Disease control rate

    Time frame: From date of initiation of treatment until the date of disease progression, assessed up to 23 months

    Rate of best objective response, including complete response, partial response and stabel disease

  4. Rate of treatment-associated adverse events.

    Time frame: Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months.

    Common Terminology Criteria for Adverse Events version 3.0 was used for evaluating treatment-associated adverse events.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

Prognostic Value of EGFR Expression, KRAS Mutation and Tumor Sideness in Patients With Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI as a Third- or Fourth-line Setting

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2018
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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