Trial document




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  DRKS00009451

Trial Description

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Title

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

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Trial Acronym

PERCOG

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URL of the Trial

http://-

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Brief Summary in Lay Language

This study aims to improve the general condition of patients with locally advanced cancer of the stomach or the junction between the stomach and esophagus, by additional application of intravenous nutrition fluids during preoperative chemotherapy in order to decrease the rate of postoperative complications.

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Brief Summary in Scientific Language

This randomized controlled study aims to improve the general condition of patients with non-metastasized gastric or esophagi-gastric cancer staged uT2 to uT4 by supplemental parenteral nutrition during neoadjuvant chemotherapy in order to decrease the postoperative Comprehensive Complication Index (CCI) on the 30th postoperative day.

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Organizational Data

  •   DRKS00009451
  •   2017/07/03
  •   [---]*
  •   yes
  •   Approved
  •   100/17 Af, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  •   U1111-1175-3259 
  •   2015-005219-34 
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Health Condition or Problem studied

  •   C16 -  Malignant neoplasm of stomach
  •   R64 -  Cachexia
  •   C16.0 -  Malignant neoplasm: Cardia
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Interventions/Observational Groups

  •   Daily amount of 600 kcal of supportive, parenteral nutrition during preoperative neoadjuvant chemotherapy
  •   Neoadjuvant chemotherapy without provision of supplemental parenteral nutrition.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   III
  •   No
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Primary Outcome

Comprehensive Complication Index on day 30 after oncologic resection

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Secondary Outcome

1.) Registration of the complication rate during neoadjuvant chemotherapy according to the Common Terminology Criteria for Adverse SEvents (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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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/03/01
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

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    • Technische Universität München, Fakultät für Medizin,
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Klinik und Poliklinik für Chirurgie, Technische Universität München
    • Mr.  PD Dr.  Daniel  Reim 
    • Ismaninger Strasse 22
    • 81675  München
    • Germany
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    • Klinik und Poliklinik für Chirurgie, Technische Universität München
    • Mr.  PD Dr.  Daniel  Reim 
    • Ismaninger Strasse 22
    • 81675  München
    • Germany
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Sources of Monetary or Material Support

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    • B.Braun Melsungen AG
    • Carl-Braun-Straße 1
    • 34212  Melsungen
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.