Elderly Metastatic Colorectal Cancer Patients Clinical Trial
Official title:
Randomized Phase II Study of First-Line FOLFOX Plus Panitumumab Versus 5FU Plus Panitumumab in RAS And BRAF Wild-Type Metastatic Colorectal Cancer Elderly Patients
- Few data are available about the treatment of metastatic colorectal cancer (mCRC)
elderly patients with anti-EGFR agents in combination with chemotherapy. Up today, most
of the available data are from retrospective/post-hoc analyses, making them difficult to
translate to everyday clinical practice.
- FOLFOX plus panitumumab is a standard first-line therapy option for RAS wild-type
untreated mCRC patients. Slight adjustments in chemo-dosage are commonly applied in
routinary practice to elderly patients, but those modified schedules have never been
prospectively tested.
- In elderly patients, a reasonable upfront treatment is a fluoropyrimidine-based
monotherapy plus bevacizumab, irrespectively of the molecular status of RAS.
- BRAF mutation is a strong negative prognostic factor associated to advanced age, poor
performance status (PS), extended and aggressive disease and is associated to a lack of
benefit from anti-EGFR moAb.
- Clinical definition of elderly (over 70 years old) CRC patients 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 approaches31.
- Several geriatric screening tools have been used to identify patients with a geriatric
profile potentially predicting for overall survival and risk of toxicity. The G8
screening tool has been validated in cancer patients showing the strongest prognostic
value for overall survival; the CRASH score is able to stratify patients according an
estimated risk of treatment-related toxicities.
On the basis of these considerations, the investigators designed the present randomized phase
II trial of first-line therapy panitumumab in combination with simplified FOLFOX or with
5-fluorouracil, in previously untreated elderly patients with RAS and BRAF wild-type
unresectable mCRC.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03449914 -
The GOLD Study: G8 in OLDer Patients
|
||
| Active, not recruiting |
NCT03451370 -
First-line Combination of Capecitabine and Oxaliplatin Plus Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer
|