A Phase 2 interventional study of Regorafenib 160 mg in Colorectal Adenocarcinoma, sponsored by Federation Francophone de Cancerologie Digestive. Completed at 16 sites in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.
Sponsored by Federation Francophone de Cancerologie Digestive · Phase 2, Interventional, and Treatment
Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 43 is close to the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Federation Francophone de Cancerologie Digestive is the lead sponsor of 61 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Regorafenib 160 mg
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
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
Between January 2016 to April 2017, 43 patients were enrolled in the trial by 25 centers in France.
| Milestone | Regorafenib 160 mg |
|---|---|
| Started | 43 |
| Completed | 42 |
| Not completed | 1 |
| Withdrew: Patient not treated | 1 |
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.
| Percentage of patients | Regorafenib 160 mg |
|---|---|
| Percentage of Patients With a Tumoral Control Rate at 2 Months | 31.4 (18.7 to 46.6) |
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.
| months | Regorafenib 160 mg |
|---|---|
| Overall Survival | 7.5 (5.5 to 10.6) |
Collected over Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Regorafenib 160 mg | 36/42 (85.7%) | 17/42 (40.5%) | 42/42 (100%) |
| Event | Regorafenib 160 mg |
|---|---|
| FatigueGeneral disorders | 5/42 |
| FallInjury, poisoning and procedural complications | 3/42 |
| HypertensionCardiac disorders | 2/42 |
| Cerebrovascular ischemiaNervous system disorders | 2/42 |
| Pulmonary embolismVascular disorders | 1/42 |
| HaematomaCardiac disorders | 1/42 |
| TachycardiaCardiac disorders | 1/42 |
| HeadacheNervous system disorders | 1/42 |
| Neuropathy peripheralNervous system disorders | 1/42 |
| DiarrhoeaGastrointestinal disorders | 1/42 |
| Event | Regorafenib 160 mg |
|---|---|
| FatigueGeneral disorders | 34/42 |
| Gamma-glutamyltransferase increasedInvestigations | 31/42 |
| AnorexiaMetabolism and nutrition disorders | 23/42 |
| Total Bilirubin increasedInvestigations | 22/42 |
| Aspartate aminotransferase increasedInvestigations | 21/42 |
| Phosphatases Alcalines increasedInvestigations | 21/42 |
| Platelets decreasedInvestigations | 20/42 |
| AnemiaBlood and lymphatic system disorders | 19/42 |
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 18/42 |
| Diarrhoea subjectsGastrointestinal disorders | 17/42 |
All the patients enrolled in the study and treated by Regorafenib
| Age, Continuous(years) | Regorafenib 160 mg |
|---|---|
| Mean | 77.9 ± 5.5 |
| Sex: Female, Male(Participants) | Regorafenib 160 mg |
|---|---|
| Female | 14 |
| Male | 28 |
| Ethnicity (NIH/OMB)(Participants) | Regorafenib 160 mg |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 42 |
| Region of Enrollment(participants) | Regorafenib 160 mg |
|---|---|
| France | 42 |
| Koehne Score(Participants) | Regorafenib 160 mg |
|---|---|
| Low | 16 |
| Intermediate | 22 |
| High | 4 |
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Federation Francophone de Cancerologie Digestive