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Regorafenib 160 mg

Thomas APARICIO, Pr

Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer

Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .

Phase II Study Evaluating the Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years Old With a Metastatic Colorectal Adenocarcinoma .

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.

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.

Federation Francophone de Cancerologie Digestive

Regorafenib monotherapy at an initial dose of 160 mg once daily orally (21 days on, 7 days off treatment)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

France

Region of Enrollment

Low is for patients with OMS equal to 0 or 1 and with 1 metastatic site

Intermediate is for patients with 0MS equal to 0-1 and with more than 1 metastatic site and Phosphatases Alcalines \<300 U/L, or patients with OMS \>1 and WBC \<10.109/L and 1 metastatic site

Higi is for patients with OMS 0/1 and with more than 1 metastatic site and with phosphatases alcalines \> 300 U/L or patients with OMS \> 1 and with more than 1 metastatic site or patients with WBC \>10.109 /L

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .	NCT02788006	Colorectal Aden...	Regorafenib 160...	70 Years -	Federation Francophone de Cancerologie Digestive
Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .	NCT02788006	Colorectal Aden...	Regorafenib 160...	70 Years -	Federation Francophone de Cancerologie Digestive

Spots Global Cancer Trial Database for regorafenib 160 mg