Prediction of hematotoxicity and non-hematological toxicity of systemic therapies and other clinical outcome parameters for patients with locally advanced gastric cancer or gastroesophageal transition (AEG I-III by Siewert) and patients with pancreatic carcinoma

Recruiting

• Conditions: C15; C16; C25; Malignant neoplasm of oesophagus; Malignant neoplasm of stomach; Malignant neoplasm of pancreas

• Registration Number: DRKS00021415
• Lead Sponsor: niversitäres Krebszentrum Leipzig (UCCL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary study goals are the prediction of non-haematological toxicities and other clinical outcome parameters that<br>examination of the quality of life by means of standardised questionnaires (EORTC QLQ-C30 and EORTC QLQ-OG25), which<br>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.