Trial Outcomes & Findings for [18F]FLT-PET as a Predictive Imaging Biomaker of Treatment Responses to Regorafenib (NCT NCT02175095)
NCT ID: NCT02175095
Last Updated: 2024-10-04
Results Overview
Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0. The peak SUV value corrected for lean body mass (SULpeak) was measured from the single hottest tumour at each time point. For a tumour to be measurable at baseline, the SULpeak in the target lesion was greater than or equal to 1.5 times the mean SUL in the 3-cm-diameter spherical volume of interest plus two times its standard deviation of the liver. The percentage of change in SULpeak in the measurable target lesion was computed as follows: 100×(SULpeak day 21-SULpeak baseline)/SULpeak baseline. When a non-target lesion showed different responses from the measurable target lesion, we used the overall response considering both the target and non-target responses as previously described. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) by CT scans at 8 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Regorafenib was administered orally at a dose of 160 mg/day on days 1 to 21 following a 7-day break, with each cycle lasting 4 weeks. Treatment was repeated every 4 weeks and continued until disease progression, unacceptable toxicity, or patient refusal.
Results posted on
2024-10-04
Participant Flow
Participant milestones
| Measure |
Regorafenib and FLT-PET
After checking the eligibility for the study entry, patients will be scheduled to perform \[18F\]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy). Additional \[18F\]FDG-PET will be performed before treatment and at 8 weeks (just once at the point of first response evaluation).
Regorafenib: After checking the eligibility for the study entry, patients will be scheduled to perform \[18F\]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy).
|
|---|---|
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Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Regorafenib and FLT-PET
After checking the eligibility for the study entry, patients will be scheduled to perform \[18F\]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy). Additional \[18F\]FDG-PET will be performed before treatment and at 8 weeks (just once at the point of first response evaluation).
Regorafenib: After checking the eligibility for the study entry, patients will be scheduled to perform \[18F\]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy).
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|---|---|
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Overall Study
Withdrawal by Subject
|
3
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Baseline Characteristics
This status was for the patient who got previous targeted agents.
Baseline characteristics by cohort
| Measure |
Regorafenib and FLT-PET
n=68 Participants
Baseline characteristics of patients with metastatic colorectal cancer receiving Regorafenib
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=68 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=68 Participants
|
|
Age, Continuous
|
58 years
n=68 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=68 Participants
|
|
Region of Enrollment
South Korea
|
68 participants
n=68 Participants
|
|
ECOG Performance Status 0-1
|
68 Participants
n=68 Participants
|
|
Primary tumour
Right colon
|
11 Participants
n=68 Participants
|
|
Primary tumour
Left colon
|
25 Participants
n=68 Participants
|
|
Primary tumour
Rectum
|
32 Participants
n=68 Participants
|
|
Histology
Well differentiated
|
7 Participants
n=68 Participants
|
|
Histology
Moderately differentiated
|
52 Participants
n=68 Participants
|
|
Histology
Poorly differentiated
|
6 Participants
n=68 Participants
|
|
Histology
Mucinous differentiated
|
3 Participants
n=68 Participants
|
|
Status
Initially metastatic
|
39 Participants
n=68 Participants
|
|
Status
Recurrence with metastasis
|
29 Participants
n=68 Participants
|
|
Site of metastasis
Liver
|
28 Participants
n=68 Participants
|
|
Site of metastasis
Lung
|
57 Participants
n=68 Participants
|
|
Site of metastasis
Lymph node, abdomen
|
29 Participants
n=68 Participants
|
|
Site of metastasis
Peritoenum/omentum
|
11 Participants
n=68 Participants
|
|
Site of metastasis
Bone
|
7 Participants
n=68 Participants
|
|
Site of metastasis
Ovary
|
2 Participants
n=68 Participants
|
|
RAS status
Wild
|
34 Participants
n=68 Participants
|
|
RAS status
Mutant
|
31 Participants
n=68 Participants
|
|
RAS status
Unknown
|
3 Participants
n=68 Participants
|
|
BRAF status
Wild
|
55 Participants
n=68 Participants
|
|
BRAF status
Mutant
|
4 Participants
n=68 Participants
|
|
BRAF status
Unknown
|
9 Participants
n=68 Participants
|
|
Previous targeted agents
None
|
21 Participants
n=68 Participants
|
|
Previous targeted agents
Any
|
47 Participants
n=68 Participants
|
|
Previous chemotherapy
2 lines of chemotherapy
|
24 Participants
n=68 Participants
|
|
Previous chemotherapy
3 lines of chemotherapy
|
21 Participants
n=68 Participants
|
|
Previous chemotherapy
≥4 lines of chemotherapy
|
23 Participants
n=68 Participants
|
|
Previous targeted agents
Anti-VEGF but not anti-EGFR
|
28 Participants
n=47 Participants • This status was for the patient who got previous targeted agents.
|
|
Previous targeted agents
Anti-EGFR but not anti-VEGF
|
9 Participants
n=47 Participants • This status was for the patient who got previous targeted agents.
|
|
Previous targeted agents
Anti-VEGF and anti-EGFR
|
10 Participants
n=47 Participants • This status was for the patient who got previous targeted agents.
|
PRIMARY outcome
Timeframe: Regorafenib was administered orally at a dose of 160 mg/day on days 1 to 21 following a 7-day break, with each cycle lasting 4 weeks. Treatment was repeated every 4 weeks and continued until disease progression, unacceptable toxicity, or patient refusal.Population: Both 18F-FLT and 18F-FDG PET/CT scans were performed in 64 patients; among the remaining four patients, one withdrew consent and three discontinued Regorafenib treatment during the first cycle because of toxicities. With the exception of three patients who had no follow-up CT (n = 2) or no uptake of 18F-FLT (n = 1), 61 were evaluable for the treatment response on both CT and PET/CT in final.
Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0. The peak SUV value corrected for lean body mass (SULpeak) was measured from the single hottest tumour at each time point. For a tumour to be measurable at baseline, the SULpeak in the target lesion was greater than or equal to 1.5 times the mean SUL in the 3-cm-diameter spherical volume of interest plus two times its standard deviation of the liver. The percentage of change in SULpeak in the measurable target lesion was computed as follows: 100×(SULpeak day 21-SULpeak baseline)/SULpeak baseline. When a non-target lesion showed different responses from the measurable target lesion, we used the overall response considering both the target and non-target responses as previously described. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) by CT scans at 8 weeks.
Outcome measures
| Measure |
Response Evaluation Criteria In Solid Tumors Criteria (RECIST)
n=61 Participants
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) by CT scans at 8 weeks.
Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
|
PET Response Criteria in Solid Tumours (PERCIST)
n=61 Participants
Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.
The peak SUV value corrected for lean body mass (SULpeak) was measured from the single hottest tumour at each time point.
The percentage of change in SULpeak in the measurable target lesion was computed as follows:
100×(SULpeak day 21-SULpeak baseline)/SULpeak baseline. When a non-target lesion showed different responses from the measurable target lesion, we used the overall response considering both the target and non-target responses as previously described.
Complete metabolic response (CMR)= complete resolution of 18F-FDG uptake within the measurable target lesion/disappearance of all other lesions to background blood pool levels/no new suspicious 18F-FDG avid lesions; Partial metabolic response (PMR)=reduction of a minimum of 30% in target measurable tumor 18F-FDG SUL peak, with absolute drop in SUL of at least 0.8 SUL units/no increase \>30% of SUL or size in all other lesions; Stable metabolic disease (SMD)=no CMR, PMR, or progressive metabolic disease (PMD); Progressive metabolic disease (PMD)=\>30% increase in 18F-FDG SUL peak, with \>0.8 SUL units increase in tumor SUL from the baseline scan in pattern typical of tumor and not of infection/treatment effect or new 18F-FDG avid lesions typical of cancer and not related to treatment effect and/or infection
|
Non-progressive Metabolic Disease Group (Non-PMD Group)
PMR+SMD, Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.
|
Progressive Metabolic Disease Group (PMD Group)
PMD, Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.
|
Responders on 18F-FLT PET/CT
patients showing a decrease of SUVmax ≥10.6%
|
Non-Responders on 18F-FLT PET/CT
patients showing a decrease of SUVmax \<10.6% or new lesion.
|
Concordant Pairs of Responders on Day 21 18F-FLT PET/CT and 8 Weeks CT
All the responders on 18F-FLT PET/CT met the criteria for responders on 8weeks CT
|
Concordant Pairs of Non-responders on Day 21 18F-FLT PET/CT and 8 Weeks CT
All the non-responders on 18F-FLT PET/CT met the criteria for non-responders on 8weeks CT
|
Partial Response Group (PR Group)
PR, according to RECIST on CT at 8 weeks of Regorafenib.
|
Non-Partial Response Group (Non-PR Group)
SD+PD, according to RECIST on CT at 8 weeks of Regorafenib.
|
Non-Progressive Disease Group (Non-PD Group)
PR+SD, according to RECIST on CT at 8 weeks of Regorafenib
|
Progressive Disease Group (PD Group)
PD, according to RECIST on CT at 8 weeks of Regorafenib
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Assessment of Early Response by 18F-Fluorodeoxyglucose(18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT) on Day 21 of Regorafenib Compared With the Response Rate of CT RECIST at 8 Weeks
Partial response; Partial metabolic response
|
5 Participants
|
28 Participants
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Assessment of Early Response by 18F-Fluorodeoxyglucose(18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT) on Day 21 of Regorafenib Compared With the Response Rate of CT RECIST at 8 Weeks
Stable disease; Stable metabolic disease
|
41 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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Assessment of Early Response by 18F-Fluorodeoxyglucose(18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT) on Day 21 of Regorafenib Compared With the Response Rate of CT RECIST at 8 Weeks
Progressive disease; Progressive metabolic disease
|
15 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
PRIMARY outcome
Timeframe: Regorafenib was administered orally at a dose of 160 mg/day on days 1 to 21 following a 7-day break, with each cycle lasting 4 weeks. Treatment was repeated every 4 weeks and continued until disease progression, unacceptable toxicity, or patient refusal.PET response of 18F-FLT was assessed using the SUVmax. The percentage of change of SUVmax in the target lesion was calculated as follows: 100 ×(SUVmax day 21-SUVmax baseline)/SUVmax baseline. The non responders on 18F-FLT PET/CT were defined as those with decreased SUVmax \<10.6% or new lesions on a follow-up scan. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) by CT scans at 8 weeks.
Outcome measures
| Measure |
Response Evaluation Criteria In Solid Tumors Criteria (RECIST)
n=61 Participants
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) by CT scans at 8 weeks.
Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
|
PET Response Criteria in Solid Tumours (PERCIST)
Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.
The peak SUV value corrected for lean body mass (SULpeak) was measured from the single hottest tumour at each time point.
The percentage of change in SULpeak in the measurable target lesion was computed as follows:
100×(SULpeak day 21-SULpeak baseline)/SULpeak baseline. When a non-target lesion showed different responses from the measurable target lesion, we used the overall response considering both the target and non-target responses as previously described.
Complete metabolic response (CMR)= complete resolution of 18F-FDG uptake within the measurable target lesion/disappearance of all other lesions to background blood pool levels/no new suspicious 18F-FDG avid lesions; Partial metabolic response (PMR)=reduction of a minimum of 30% in target measurable tumor 18F-FDG SUL peak, with absolute drop in SUL of at least 0.8 SUL units/no increase \>30% of SUL or size in all other lesions; Stable metabolic disease (SMD)=no CMR, PMR, or progressive metabolic disease (PMD); Progressive metabolic disease (PMD)=\>30% increase in 18F-FDG SUL peak, with \>0.8 SUL units increase in tumor SUL from the baseline scan in pattern typical of tumor and not of infection/treatment effect or new 18F-FDG avid lesions typical of cancer and not related to treatment effect and/or infection
|
Non-progressive Metabolic Disease Group (Non-PMD Group)
PMR+SMD, Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.
|
Progressive Metabolic Disease Group (PMD Group)
PMD, Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.
|
Responders on 18F-FLT PET/CT
patients showing a decrease of SUVmax ≥10.6%
|
Non-Responders on 18F-FLT PET/CT
patients showing a decrease of SUVmax \<10.6% or new lesion.
|
Concordant Pairs of Responders on Day 21 18F-FLT PET/CT and 8 Weeks CT
All the responders on 18F-FLT PET/CT met the criteria for responders on 8weeks CT
|
Concordant Pairs of Non-responders on Day 21 18F-FLT PET/CT and 8 Weeks CT
All the non-responders on 18F-FLT PET/CT met the criteria for non-responders on 8weeks CT
|
Partial Response Group (PR Group)
PR, according to RECIST on CT at 8 weeks of Regorafenib.
|
Non-Partial Response Group (Non-PR Group)
SD+PD, according to RECIST on CT at 8 weeks of Regorafenib.
|
Non-Progressive Disease Group (Non-PD Group)
PR+SD, according to RECIST on CT at 8 weeks of Regorafenib
|
Progressive Disease Group (PD Group)
PD, according to RECIST on CT at 8 weeks of Regorafenib
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Assessment of Early Response by Using 3'-Deoxy-3'-18F-fluorothymidine (18F-FLT) Positron Emission Tomography/Computed Tomography (PET/CT) on Day 21 of Regorafenib Compared With the Response Rate of CT RECIST at 8 Weeks
Responders on 18F-FLT PET/CT and Responders on RECIST
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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Assessment of Early Response by Using 3'-Deoxy-3'-18F-fluorothymidine (18F-FLT) Positron Emission Tomography/Computed Tomography (PET/CT) on Day 21 of Regorafenib Compared With the Response Rate of CT RECIST at 8 Weeks
Responders on 18F-FLT PET/CT and Non-Responders on RECIST
|
43 Participants
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
|
—
|
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Assessment of Early Response by Using 3'-Deoxy-3'-18F-fluorothymidine (18F-FLT) Positron Emission Tomography/Computed Tomography (PET/CT) on Day 21 of Regorafenib Compared With the Response Rate of CT RECIST at 8 Weeks
Non-Responders on 18F-FLT PET/CT and Responders on RECIST
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Early Response by Using 3'-Deoxy-3'-18F-fluorothymidine (18F-FLT) Positron Emission Tomography/Computed Tomography (PET/CT) on Day 21 of Regorafenib Compared With the Response Rate of CT RECIST at 8 Weeks
Non-Responders on 18F-FLT PET/CT and Non-Responders on RECIST
|
13 Participants
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Regardless of the reason for discontinuation, all subjects will be followed for survival until death is documented, except for those who specifically withdraw consent to follow-up.Outcome measures
| Measure |
Response Evaluation Criteria In Solid Tumors Criteria (RECIST)
n=28 Participants
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) by CT scans at 8 weeks.
Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
|
PET Response Criteria in Solid Tumours (PERCIST)
n=33 Participants
Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.
The peak SUV value corrected for lean body mass (SULpeak) was measured from the single hottest tumour at each time point.
The percentage of change in SULpeak in the measurable target lesion was computed as follows:
100×(SULpeak day 21-SULpeak baseline)/SULpeak baseline. When a non-target lesion showed different responses from the measurable target lesion, we used the overall response considering both the target and non-target responses as previously described.
Complete metabolic response (CMR)= complete resolution of 18F-FDG uptake within the measurable target lesion/disappearance of all other lesions to background blood pool levels/no new suspicious 18F-FDG avid lesions; Partial metabolic response (PMR)=reduction of a minimum of 30% in target measurable tumor 18F-FDG SUL peak, with absolute drop in SUL of at least 0.8 SUL units/no increase \>30% of SUL or size in all other lesions; Stable metabolic disease (SMD)=no CMR, PMR, or progressive metabolic disease (PMD); Progressive metabolic disease (PMD)=\>30% increase in 18F-FDG SUL peak, with \>0.8 SUL units increase in tumor SUL from the baseline scan in pattern typical of tumor and not of infection/treatment effect or new 18F-FDG avid lesions typical of cancer and not related to treatment effect and/or infection
|
Non-progressive Metabolic Disease Group (Non-PMD Group)
n=52 Participants
PMR+SMD, Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.
|
Progressive Metabolic Disease Group (PMD Group)
n=9 Participants
PMD, Response assessment using 18F-FDG PET/CT was based on the PERCIST 1.0.
|
Responders on 18F-FLT PET/CT
n=48 Participants
patients showing a decrease of SUVmax ≥10.6%
|
Non-Responders on 18F-FLT PET/CT
n=13 Participants
patients showing a decrease of SUVmax \<10.6% or new lesion.
|
Concordant Pairs of Responders on Day 21 18F-FLT PET/CT and 8 Weeks CT
n=5 Participants
All the responders on 18F-FLT PET/CT met the criteria for responders on 8weeks CT
|
Concordant Pairs of Non-responders on Day 21 18F-FLT PET/CT and 8 Weeks CT
n=13 Participants
All the non-responders on 18F-FLT PET/CT met the criteria for non-responders on 8weeks CT
|
Partial Response Group (PR Group)
n=5 Participants
PR, according to RECIST on CT at 8 weeks of Regorafenib.
|
Non-Partial Response Group (Non-PR Group)
n=56 Participants
SD+PD, according to RECIST on CT at 8 weeks of Regorafenib.
|
Non-Progressive Disease Group (Non-PD Group)
n=46 Participants
PR+SD, according to RECIST on CT at 8 weeks of Regorafenib
|
Progressive Disease Group (PD Group)
n=15 Participants
PD, according to RECIST on CT at 8 weeks of Regorafenib
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Survival Outcomes According to 18F-FLT and 18F-FDG PET/CT Response on Day 21 of Regorafenib and RECIST on CT at 8 Weeks of Regorafenib
Overall survival (OS)
|
11.8 months
Interval 7.54 to 16.13
|
7.9 months
Interval 5.25 to 10.62
|
3.9 months
Interval 2.22 to 6.18
|
10.5 months
Interval 8.07 to 12.83
|
11.6 months
Interval 7.33 to 13.85
|
7.0 months
Interval 4.45 to 9.45
|
10.6 months
Interval 7.33 to 13.85
|
7.0 months
Interval 4.45 to 9.45
|
22.5 months
Interval 0.0 to 45.64
|
9.2 months
Interval 7.47 to 11.01
|
10.7 months
Interval 8.0 to 13.37
|
4.6 months
Interval 1.83 to 7.48
|
|
Survival Outcomes According to 18F-FLT and 18F-FDG PET/CT Response on Day 21 of Regorafenib and RECIST on CT at 8 Weeks of Regorafenib
Progression-free survival(PFS)
|
3.9 months
Interval 1.6 to 6.27
|
3.5 months
Interval 3.26 to 3.76
|
1.8 months
Interval 0.0 to 3.79
|
3.6 months
Interval 3.18 to 4.02
|
3.9 months
Interval 1.93 to 5.87
|
3.4 months
Interval 2.72 to 4.16
|
9.0 months
Interval 2.44 to 15.53
|
3.4 months
Interval 2.72 to 4.16
|
8.9 months
Interval 2.43 to 15.53
|
3.5 months
Interval 3.45 to 3.63
|
5.3 months
Interval 3.36 to 7.33
|
1.6 months
Interval 1.33 to 1.88
|
Adverse Events
Regorafenib and FLT-PET
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Regorafenib and FLT-PET
n=68 participants at risk
After checking the eligibility for the study entry, patients will be scheduled to perform \[18F\]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy). Additional \[18F\]FDG-PET will be performed before treatment and at 8 weeks (just once at the point of first response evaluation).
Regorafenib: After checking the eligibility for the study entry, patients will be scheduled to perform \[18F\]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy).
|
|---|---|
|
Skin and subcutaneous tissue disorders
hand foot syndrome
|
1.5%
1/68 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.5%
1/68 • Number of events 1
|
|
Hepatobiliary disorders
elevated AST/ALT
|
1.5%
1/68 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place