Additional nutrition during chemotherapy ahead of surgery in esophageal, GE-junction, stomach, pancreas or rectum cancer for reduction of postoperative complications

Phase 1

• Conditions: ocally advanced carcinoma of the GE-junction or esophagus (adenocarcinoma or squamous cell carcinoma), gastric antrum, body or fundus or carcinoma of the pancreas or carcinoma of the rectum requiring neoadjuvant treatment ahead of surgery (chemotherapy and/or chmoradiotherapy); MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 20.1Level: PTClassification code 10062878Term: Gastrooesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10015362Term: Esophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2015-005219-34-DE
• Lead Sponsor: Technische Universitaet Muenchen Fakultaet fuer Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-20
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Histologically proven locally advanced carcinoma of
GE- junction or
Esophagus or
Stomach or
Pancreas or
Rectum
Requiring neoadjuvant chemotherapy or radio-(chemo-)therapy ahead of surgery
2. Nutritional Risk Score (NRS) =3
3. Age>18 years
4. ECOG grade 0-2
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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Non-resectable carcinoma of the GE-junction, esophagus, stomach, pancreas or rectum
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 clinical trial of medicinal product
• Study Design: Not specified