Parenteral nutrition during neoadjuvant chemotherapy for patients with non-metastatic gastric or gastroesophageal cancer to reduce postoperative morbidity

Phase 3

• Conditions: C16; R64; C16.0; Malignant neoplasm of stomach; Cachexia; Cardia

• Registration Number: DRKS00009451
• Lead Sponsor: Technische Universität München, Fakultät für Medizin,

Brief Summary

SPN cannot be recommended for reduction of postoperative complications after neoadjuvant multimodal therapy for gastro-esophageal, pancreatic or rectal cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-03
• Study Completion: 2021-08-03
• Results First Posted: 2022-10-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1.) Histologically proven resectable adenocarcinoma of the stomach or gastroesophageal junction (AEG I-III) staged cT2/cN+ to cT4/cNany without distant metastasis.
2.) Age >= 18 years
3.) ECOG stage 0-2
4.) Nutritional Risk Score (NRS) =3
5.) Negative proof of pregnancy for potentially childbearing women.
6.) Sufficient bone-marrow, liver- and kidney-function according to the attending oncologist´s expert opinion.

Exclusion Criteria

1.) Non-resectable adenocarcinoma of the stomach or gastroesophageal junction.
2.) Participation in a different randomized controlled trial potentially interfering with the primary endpoint.
3.) Pregnancy or breast feeding.
4.) Impairing cardiac disease such as unstabel angina pectoris, unstable coronary heart disease, cardiac failure (NYHA IV), malignant hypertension) or pulmonary disease (COPD stage GOLD IV), representeing a contraindication to neoadjuvant chemotherapy or surgical resection.
5.) Insufficient patient compliance.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comprehensive Complication Index on day 30 after oncologic resection

Secondary Outcome Measures

Name	Time	Method
1.) Registration of the complication rate during neoadjuvant chemotherapy according to the Common Terminology Criteria for Adverse SEvents (CTCAE v4.03).<br>2.) Registration of the complication rate associated with application of parenteral nutrition according to CTCAE v4.03.<br>3.) Registration of the total amount of complications and postoperative morbidity within a postoperative period of 30 days according to the Clavien-Dindo classification and CTCAE v4.03.<br>4.) Registration of Quality of Life according to EORTC QLQ-C30 questionnaire.<br>5.) Development of body weight and BMI<br>6.) Length of hospital stay<br>7.) Length of ICU stay