adenocarcinoma colon cancer
Conditions
Interventions
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age >=18. - Histological confirmed colon cancer, (high risk stage II or stage III*), or rectal cancer. - Colon or rectal (rectosigmoid, treated as colon) cancer patients who will receive adjuvant chemotherapy. - Signed informed consent for participation in the PLCRC study (including informed consent for the collection of blood samples, invitation to future research and filling in questionnaires). - Signed informed consent for the PLCRC-PROTECT study. - Signed informed consent for the PLCRC-PROTECT+ study.
Exclusion criteria
Exclusion criteria: - Non Dutch speaking patients. - Mentally incompetent patients. - Patients that receive(d) neo-adjuvant chemotherapy - Patients who received one or more cycles of systemic therapy in the past 6 months. - Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter of this observational study is overall grade 2-4 treatment-related toxicity. All clinical parameters and data on colon cancer outcome will be gathered from PLCRC (data management performed by the Netherlands Cancer Registry (NCR)). Grade 2 toxicity will not be recorded in the NKR+ database. In order to be able to obtain data on the occurrence of grade 2-4 toxicity during adjuvant chemotherapy, the treating medical oncologist has to document the toxicities very accurately. Subsequently, the study team of PLCRC-PROTECT+ have to gather the grade 2-4 toxicity data from the electronic patient files. Furthermore, we will make use of *Electronic Patient Reported Outcomes* (ePRO) to measure treatment toxicities. We send out short digital questionnaires, one week after administration of every adjuvant chemotherapy cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters of this observational study are: specific subgroups of overall grade 2-4 treatment-related toxicity, total chemotherapy adherence and adherence at each chemotherapy cycle, dose reductions with reason, drug delay or premature ending of chemotherapy. Furthermore, PIFA levels, treatment response (disease progression and recurrence) and quality of life data, during and after chemotherapy will be secondary parameters. All clinical parameters (except for toxicity data) and data on colon cancer outcome will be gathered from the PLCRC observational cohort study and the NCR. | — |
Countries
The Netherlands
Outcome results
None listed