C15 C16 C25
Conditions
Interventions
Group 1: Patients are monitored over the course of the planned treatment and data on the course of the disease and their quality of life during the therapy are regularly collected. For this purpose bl
Sponsors
Universitäres Krebszentrum Leipzig (UCCL)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with locally advanced carcinoma of the stomach, gastroesophageal transition (AEG I-III by Siewert) or pancreas receiving systemic chemotherapy, signed consent form, legal age (= 18 years)
Exclusion criteria
Exclusion criteria: Minority (< 18 years), missing consent form, presence of pronounced anemia (the hemoglobin value of <=4.6 mmol/l serves as a guideline), pregnant and nursing patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study objective is to predict the hematotoxicity of perioperative systemic chemotherapy. For this purpose, close blood count controls are performed in the preoperative cycles. The endpoints will be assessed at the specified time points and the final evaluation of the endpoints will be performed when the complete data set of all included and documented patients is available. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study goals are the prediction of non-haematological toxicities and other clinical outcome parameters that examination of the quality of life by means of standardised questionnaires (EORTC QLQ-C30 and EORTC QLQ-OG25), which validation of the modified Hurria Score in the older patient group (= 65 years) and the identification of age-related differences in toxicity and other clinical outcomes by descriptive analysis and generation of a database. For this purpose, the CTC criteria are queried on day 1 of each cycle, EORTC QLQ C30/ QLQ-OG25 - surveys in cycle 1, cycle 4, in the 1st postoperative week, in cycle 8 and about half a year after surgery. The Hurria Score is already collected at the screening. The endpoints will be collected at the specified times and the final evaluation of the endpoints will be made when the complete data set of all included and documented patients is available. | — |
Countries
Germany
Contacts
Public ContactVivien;Florian Topf;Lordick
Universitäres Krebszentrum Leipzig (UCCL);Universitäres Krebszentrum Leipzig (UCCL)
Outcome results
None listed