Status:
COMPLETED
NICSO National Study: Physician - Nurse Monitoring Project About Oncological Adverse Events
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The lacking adherence to guidelines on prevention and treatment of different chemotherapy, targeted therapy, and immunotherapy induced toxicities is the reason why there are a potential incidence and ...
Detailed Description
The lacking adherence to guidelines on prevention and treatment of different chemotherapy, targeted therapy, and immunotherapy induced toxicities is the reason why there are a potential incidence and ...
Eligibility Criteria
Inclusion
- Patients aged \>18;
- Solid cancer histological diagnosis on treatment with one of the listed medicines, defined by treatment type:
- Adjuvant chemotherapy:
- anthracyclines and cyclophosphamide ± taxanes (breast cancer)
- oxaliplatin e fluoropyrimidine (colon cancer)
- combination of platin or its derivate (lung cancer)
- First line oral target therapy:
- sunitinib, pazopanib (renal cancer)
- gefitinib, erlotinib,afatinib, crizotinib (lung cancer)
- vemurafenib ± comimetinib, dabrafenib±trametinib (Melanoma)
- everolimus ± exemestane (breast cancer)
- vandetanib o lenvatinib (thyroid cancer)
- vismodegib (skin basal cell carcinoma)
- imatinib (GIST)
- Immunotherapy:
- drugs anti CTLA4
- drugs antiPD1/PDL-1
- their combination
- sign of informed consent form;
- phone call availability and accessibility;
- life expectancy higher than 6 months.
Exclusion
- Presence of cerebral symptomatic metastasis;
- Presence of neurological or psychiatric disease or other conditions that stop the protocol procedure compliance;
- Previous systemic cancer treatment. These exclusion criteria are justified because usually a systemic cancer treatment cause changes in toxicity profile. This means that these patients have higher attention on their toxicities and probably receive codified preventive treatments already.
- Participation in other clinical studies
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
645 Patients enrolled
Trial Details
Trial ID
NCT04726020
Start Date
March 1 2018
End Date
January 31 2022
Last Update
August 9 2022
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133