First-line Combination of Capecitabine and Oxaliplatin Plus Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer (COBRA)
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|ClinicalTrials.gov Identifier: NCT03451370|
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
- Oxaliplatin-based doublets plus bevacizumab are standard first-line therapy options for patients (pts) with metastatic colorectal cancer (mCRC). Slight adjustments in chemo-dosage are commonly applied in routinely practice to elderly pts, but those modified schedules have never been standardized
- The addition of oxaliplatin versus no oxaliplatin to treatment with 5-fluorouracil in older and frail untreated pts with mCRC resulted in a non-statistically significant trend toward improvement in Progression Free Survival (PFS) and a lack of benefit in Overall Survival (OS)
- In elderly pts deemed unfit for an upfront combined chemotherapy a fluoropyrimide-based monotherapy plus bevacizumab is considered a reasonable first-line treatment
- Clinical definition of elderly (over 70 years old) pts with CRC that may deserve a more or less intensive combination therapy is still debated. The cut-off of 75 years old combined with ECOG PS assessment is a reasonable approach for clearly defining candidates to different approaches
- Several geriatric screening tools have been used to identify pts with a geriatric profile potentially predicting for overall survival and risk of toxicity. The G8 screening tool has been already validated in pts with cancer showing the strongest prognostic value for OS; the CRASH score is able to stratify pts according an estimated risk of treatment-related toxicities
On the basis of these considerations, we designed the present observational study of first-line therapy with bevacizumab in combination with capecitabine and oxaliplatin in previously untreated elderly pts affected by unresectable mCRC in order to evaluate its efficacy in real world practice (as measured by progression free survival)
|Condition or disease||Intervention/treatment|
|Elderly Metastatic Colorectal Cancer Patients||Drug: Capecitabine Drug: Oxaliplatin Drug: Bevacizumab|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||121 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||First-line Combination of Capecitabine and Oxaliplatin + Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||March 2021|
- Drug: Capecitabine
750 mg/sqm/bid, day 2 to 15; if toxicities grade ≥2 do not occur, pts may subsequently receive capecitabine 1000 mg/sqm/bid, day 2 to 15 starting the second cycle based on investigator's choice.
To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.
If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal.
- Drug: Oxaliplatin
100 mg/sqm iv over 2 hours, day 1 To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.
- Drug: Bevacizumab
7.5 mg/kg iv over 90 minutes, day 1; if the first infusion is tolerated, then subsequent infusions may be administered in 30 minutes.
If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal. To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.
- Progression Free Survival (PFS) [ Time Frame: Up to 28 months ]PFS is defined as the time from study enrollment to the first documentation of objective disease progression or death due to any cause, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451370
|Contact: Sara Lonardi||+39 firstname.lastname@example.org|
|Contact: Federica Buggin||+39 email@example.com|
|Istituto Oncologico Veneto IRCCS||Recruiting|
|Padua, Italy, 35128|
|Contact: Federica Buggin firstname.lastname@example.org|
|Principal Investigator: Sara Lonardi, MD|
|Sub-Investigator: Fotios Loupakis, MD|