E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally 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) |
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E.1.1.1 | Medical condition in easily understood language |
Locally advanced carcinoma of the GE-junction or esophagus or stomach or carcinoma of the pancreas or carcinoma of the rectum requiring chemotherapy or radiation therapy ahead of surgery. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10017758 |
E.1.2 | Term | Gastric cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062878 |
E.1.2 | Term | Gastrooesophageal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015362 |
E.1.2 | Term | Esophageal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033604 |
E.1.2 | Term | Pancreatic cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038038 |
E.1.2 | Term | Rectal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This randomized controlled study aims to improve the general condition during neoadjuvant chemotherapy in order to decrease the postoperative Comprehensive Complication Index on the 30th postoperative day by supplemental parenteral nutrition in patients with non-metastasized locally advanced carcinoma if the GE-junction or esophagus or stomach or pancreas or rectum requiring multimodal treatment (chemotherapy or chemoradiotherapy ahead of surgery) |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Comprehensive Complication Index on day 30 after oncologic resection |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
day 30 after surgical resection |
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E.5.2 | Secondary end point(s) |
1.) Registration of the complication rate during neoadjuvant chemotherapy according to the Common Terminology Criteria for Adverse Events (CTCAE v4.03).
2.) Registration of the complication rate associated with application of parenteral nutrition according to CTCAE v4.03.
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.
4.) Registration of Quality of Life according to EORTC QLQ-C30 questionnaire.
5.) Development of body weight and BMI
6.) Length of hospital stay
7.) Length of ICU stay |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
day 30 after surgical resection |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last patient out, last patient follow up completed |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |