An observational study in Metastatic Colorectal Cancer, sponsored by National Cancer Institute, Naples. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-21.
Sponsored by National Cancer Institute, Naples · Observational
Colorectal cancer is the third most frequent neoplasm after prostate and lung in man and breast and lung cancers in woman from Western Countries. The intensive study of predictive factors has strongly ameliorated the therapeutic flow-chart of metastatic colorectal cancer (mCRC) by allowing the selection of patients who benefit from specific therapies. In this context, the assessment of RAS (N- and K-) oncogene mutations is able to predict the response to anti-EGFR agents being mutated RAS mCRC patients resistant to these drugs. In this group of patients the use of anti-angiogenic drugs (bevacizumab and aflibercept) is predominant. Still to date there are no studies to guide oncologists in the selection of the best anti-angiogenic drug (bevacizumab beyond progression vs aflibercept) after failure of the first-line chemotherapy in RAS-M mCRC patients. The present is the first observational, pragmatic, prospective study aimed to report outcomes of mCRC patients treated with folfiri plus bevacizumab versus folfiri plus aflibercept in second-line treatment of mRAS mCRC. Furthermore, the serum levels of angiopoietin-1 (Ang-1), angiopoietin-2 (Ang-2), vascular endothelial growth factor-A and C (VEGF-A and C), stromal cell-derived factor-1 (SDF-1), platelet-derived growth factor beta (PDGF-β), basic fibroblast growth factor (bFGF), interleukin-8 (IL-8), chemokine (C-C motif) ligand 2 (CCL2), and chemokine (C-C motif) ligand 5 (CCL5) and Placental Growth Factor (PlGF), will be evaluated before starting second-line chemotherapy with bevacizumab or aflibercept in order to evidence any pattern related to response and/or prognosis. The hypothesis is that knowledge of eventual unbalance of these factors could help to select the best anti-angiogenic drug in second-line treatment of mRAS mCRC patients.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 220 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.
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mCRC RAS mutated patients progressing at with first-line chemotherapy with at first-line chemotherapy based on fluoropyrimidines, oxaliplatin and bevacizumab.
Exclusion Criteria:
mCRC RAS mutated patients progressing to first-line chemotherapy with fluoropyrimidines, oxaliplatin and bevacizumab.
Drug: Folfiri/Bevacizumab
mCRC RAS mutated patients progressing to first-line chemotherapy with fluoropyrimidines, oxaliplatin and bevacizumab.
Drug: Folfiri/Aflibercept
Irinotecan (180 mg/m2), leucovorin (400 mg/m2), fluorouracil as an intravenous bolus of 400 mg/m2, and fluorouracil as a continuous 46-h infusion of 2400 mg/m2 in combination with bevacizumab (5 mg/kg) on day 1 of each 14-day cycle.
Irinotecan (180 mg/m2), leucovorin (400 mg/m2), fluorouracil as an intravenous bolus of 400 mg/m2, and fluorouracil as a continuous 46-h infusion of 2400 mg/m2 in combination with aflibercept (4 mg/kg) on day 1 of each 14-day cycle.
Overall Survival (OS).
OS will be measured from treatment start until death from any cause.
Time frame: 3 years
Toxic effects.
Toxic effects will be assessed by CTCAE of the National Cancer Institute, version 4.0, June 14, 2010.
Time frame: 3 years
Responses' duration.
Time elapsed from date of response to progression occurrence.
Time frame: 3 years
Progression-free survival (PFS).
PFS will be determined from the date of treatment start until progression.
Time frame: 3 years
Serum level of VEGF-A (Vascular Endothelial Growth Factor-A).
The molecule will be measured through ELISA test.
Time frame: 3 years
Serum level of PlGF (Placental Growth Factor).
The molecule will be measured through ELISA test.
Time frame: 3 years
Plan to share: Undecided — Complete study protocol will be published.
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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National Cancer Institute, Naples