Active — Not RecruitingNot Applicable

First-line Combination of Capecitabine and Oxaliplatin Plus Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer

Italy121 participantsStarted 2017-11-01

Plain-language summary

* 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)

Who can participate

Age range70 Years

SexALL

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Inclusion Criteria: * Histologically proven diagnosis of colorectal cancer. * Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease. * Indication to oxaliplatin, capecitabine and bevacizumab as first line treatment. * At least one measurable lesion according to RECIST1.1 criteria. * Availability of a tumoral sample (primary and/or metastatic sites). * Age ≥ 70 years. * ECOG PS (Eastern Cooperative Oncology Group - Performance Status) 1 or 2 for pts aged 70 to 75 years; ECOG PS 0 or 1 for pts aged \> 75 years. * Life expectancy of at least 12 weeks. * Previous adjuvant chemotherapy allowed only if with fluoropyrimidine monotherapy and more than 6 months elapsed between the end of adjuvant and first relapse. * Laboratory Requirements: * Neutrophils ≥1.5 x 109/L, * Platelets ≥100 x 109/L, * Hgb ≥ 9 g/dl. * Total bilirubin ≤ 1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 x UNL (or \<5 x UNL in case of liver metastases), * Alkaline phosphatase ≤ 2.5 x UNL (or \<5 x UNL in case of liver metastases), * Creatinine clearance ≥ 50 mL/min or serum creatinine ≤1.5 x UNL, * Urine dipstick of proteinuria \<2+. Pts discovered to have 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate \<1 g of protein/24 hr. * Male subjects with female partners of childbearing potential must be willing to use adequat…

What they're measuring

Progression Free Survival (PFS)

Timeframe: Up to 28 months

Trial details

NCT IDNCT03451370

SponsorIstituto Oncologico Veneto IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-02