Colorectal Adenocarcinoma
Conditions
Brief summary
Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer
Interventions
DRUGRegorafenib 160 mg
Sponsors
Federation Francophone de Cancerologie Digestive
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Metastatic colorectal cancer with histological proof * Measurable disease according RECIST 1.1 * Age ≥ 70 years * ECOG ≤ 1 * Biological values Haemoglobin ≥ 9 g/dL, PNN ≥ 1500/mm3, platelets≥ 100 000/mm3, bilirubin ≤ 1,5N, ASAT, ALAT et PAL ≤ 2,5N (≤ 5N if hepatic metastases), lipase ≤1,5N, TP≥ 70%, Creatinine clairance ≥ 30 mL/min * Patient without response to 5FU chemotherapy or anti-vegf treatment or anti EGFR treatment (if RAS wild-type), in progression during this treatment or treatment stopped because of toxicities * Geriatric Questionnaires answered * Life-expectancy ≥ 3 months * Informed Consent Signed
Exclusion criteria
* Not able to swallow tablets (crushed tablets are not allowed) * Previous treatment with regorafenib or other multikinase treatment * Other cancer during the last 5 years, excepted in-situ cervix cancer, skin cancer non melanoma and cancer of the bladder curatively treated * Radiotherapy: with extended fields in the last 4 weeks, with limited fields in the last 2 weeks previous inclusion * Toxicity \> grade 1 not resolved with previous treatment * Major surgery in the 28 days before the inclusion * Non cicatrized injury, ulcer or bone fracture * Congestive Cardiac insufficiency classe \>2 (NYHA) * Unstable angor in the last 3 months * Myocardial Infraction in the 6 months before inclusion * HTA not controlled * Pheochromocytome * Arterial or venous thromboembolism in the past 6 months * Infection of grade \> 2 * VIH infection * B or C hepatitis necessiting a specific treatment * Cirrhosis * Suspicion of brain metastasis or brain metastasis * Haemorraghe ofgrade \>3 in the last weeks * Symptomatic Pulmonary fibrosis * Proteinuria \> grade 3 * Malabsorption * Allergy know to the treatment or to one similar treatment or to one treatment component * Systemic anti-cancer drug during the study or the the last 4 weeks * Concomitant treatment with CYP3A4 inhibitor or inductor or with UGT1A9 inhibitor * Social, psychological or medical condition which can interfere with the study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With a Tumoral Control Rate at 2 Months | 2 months after the start of treatment | Tumor control rate is defined as the percentage of patients with complete tumor response, partial tumor response, or tumor stability on regorafenib therapy at 2 months after initiation of therapy as determined by the investigator per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.1 criteria) for target lesions and assessed by CT-Scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stability : neither complete or partial response nor progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to approximatively 1 year after the end of the treatment | Overall survival was defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news wastaken into account. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome. |
Countries
France
Participant flow
Recruitment details
Between January 2016 to April 2017, 43 patients were enrolled in the trial by 25 centers in France.
Pre-assignment details
Before enrollement, standard examinations (biological, clinical, ECG) as well as geriatric questionnaires were done. In terms of imaging, abdominal and thoracic computed tomography scan or MRI were also done.
Participants by arm
| Arm | Count |
|---|---|
| Regorafenib 160 mg Regorafenib monotherapy at an initial dose of 160 mg once daily orally (21 days on, 7 days off treatment) | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patient not treated | 1 |
Baseline characteristics
| Characteristic | Regorafenib 160 mg |
|---|---|
| Age, Continuous | 77.9 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 42 Participants |
| Koehne Score High | 4 Participants |
| Koehne Score Intermediate | 22 Participants |
| Koehne Score Low | 16 Participants |
| Region of Enrollment France | 42 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 36 / 42 |
| other Total, other adverse events | 42 / 42 |
| serious Total, serious adverse events | 17 / 42 |
Outcome results
Primary
Percentage of Patients With a Tumoral Control Rate at 2 Months
Tumor control rate is defined as the percentage of patients with complete tumor response, partial tumor response, or tumor stability on regorafenib therapy at 2 months after initiation of therapy as determined by the investigator per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.1 criteria) for target lesions and assessed by CT-Scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stability : neither complete or partial response nor progression.
Time frame: 2 months after the start of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regorafenib 160 mg | Percentage of Patients With a Tumoral Control Rate at 2 Months | 31.4 Percentage of patients |
Secondary
Overall Survival
Overall survival was defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news wastaken into account. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Time frame: Up to approximatively 1 year after the end of the treatment
Population: All patients included in the study and who have been treated with regorafenib
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Regorafenib 160 mg | Overall Survival | 7.5 months |