Colorectal CancerNCT03698253
Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI
A study testing Regorafenib, UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7) in people with Colorectal Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Regorafenib, UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2013to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who do not meet the including criteria or unwilling to participate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Kaohsiung City, 807
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Being tested
- Regorafenib, UGT1A1 genotyping (TA6/TA6), UGT1A1 genotyping (TA6/TA7), UGT1A1 genotyping (TA7/TA7)
- Keywords
- EGFR, KRAS, tumor sideness, FOLFIRI, regorafenib, metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegorafenibDrug
Also called stivarga
Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle
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
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib plus FOLFIRI | Experimental | Regimen for treatment consists of irinotecan (180 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7); 120 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA7/TA7)), followedby Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks.
After every 2 cycles of each different dose of irinotecan, if adverse events (AEs) are under the grade 2, we will escalate the dose of 30 mg/m2. The estimated maximal dose of irinotecan is 260 mg/m2 for UGT1A1 genotyping (TA6/TA6); 240 mg/m2 for UGT1A1 genotyping (TA6/TA7); 180 mg/m2 for UGT1A1 genotyping (TA7/TA7).
Regorafenib is administered at adjusted doseage of 120 mg daily for 3 weeks in a 4-week cycle. Receives: Drug: Regorafenib; Genetic: UGT1A1 genotyping (TA6/TA6); Genetic: UGT1A1 genotyping (TA6/TA7); Genetic: UGT1A1 genotyping (TA7/TA7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Time from treatment to disease progresses
Measured: From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months
Secondary outcomes (4)
Overall survival
Time from treatment to death of subjectives
Measured: From date of initiation of treatment until the date of death from any cause, assessed up to 23 months
Best objective response
best response recorded during treatment
Measured: From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Disease control rate
Rate of best objective response, including complete response, partial response and stabel disease
Measured: From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Rate of treatment-associated adverse events.
Common Terminology Criteria for Adverse Events version 3.0 was used for evaluating treatment-associated adverse events.
Measured: Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start1 Oct 2013
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaw-Yuan Wang, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Jaw-Yuan Wang, PhD, Study chair, Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698253
- Sponsor's protocol ID
- KMUHIRB-E(I)-20180270
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03698253
- Acronym / sponsor ID
- KMUHIRB-E(I)-20180270
- Conditions
- Colorectal Cancer
- Keywords
- EGFR, KRAS, tumor sideness, FOLFIRI, regorafenib, metastatic colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regorafenib plus FOLFIRI | Experimental | Drug: Regorafenib, Genetic: UGT1A1 genotyping (TA6/TA6), Genetic: UGT1A1 genotyping (TA6/TA7), Genetic: UGT1A1 genotyping (TA7/TA7)Regimen for treatment consists of irinotecan (180 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7); 120 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA7/TA7)), followedby Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks. After every 2 cycles of each different dose of irinotecan, if adverse events (AEs) are under the grade 2, we will escalate the dose of 30 mg/m2. The estimated maximal dose of irinotecan is 260 mg/m2 for UGT1A1 genotyping (TA6/TA6); 240 mg/m2 for UGT1A1 genotyping (TA6/TA7); 180 mg/m2 for UGT1A1 genotyping (TA7/TA7). Regorafenib is administered at adjusted doseage of 120 mg daily for 3 weeks in a 4-week cycle. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who do not meet the including criteria or unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegorafenibAlso: stivargaRegorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle | Drug | Regorafenib plus FOLFIRI |
| UGT1A1 genotyping (TA6/TA6)The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2 | Genetic | Regorafenib plus FOLFIRI |
| UGT1A1 genotyping (TA6/TA7)The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2 | Genetic | Regorafenib plus FOLFIRI |
| UGT1A1 genotyping (TA7/TA7)The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2 | Genetic | Regorafenib plus FOLFIRI |
Primary outcome
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
4 secondary outcomes
Overall survival
Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 23 months
Best objective response
Time frame: From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Disease control rate
Time frame: From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Rate of treatment-associated adverse events.
Time frame: Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaw-Yuan Wang, PhD study chair
Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regorafenib, UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7) in people with Colorectal Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.