Investigator Initiated Trials

You can find an overview of our investigator initiated trials below. A complete overview of all open trials can be found in this pdf-file (partly in German).

Nationwide there are more than 500 academic and non-academic clinical facilities participating in our clinical trials.

RENAISSANCE (FLOT5)

Short title: Effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction – a phase III trial of AIO/CAO-V/CAOGI

Therapy: 8-12 cycles FLOT vs. 4 cycles FLOT - OP - 4-8 cycles FLOT

Start of trial: 01. July 2015

End of trial or status: recruiting

Participating centers: ca. 50

Sample size: 271

Further information: clinicaltrials.gov

PETRARCA (FLOT6)

Short title: FLOT vs. FLOT/Herceptin/Perjeta for perioperative therapy of locally advanced esophagogastric adenocarcinoma expressing HER2, a phase II/III trial of the AIO

Therapy: 4 cycles FLOT - OP - 4 cycles FLOT +/- Herceptin/Perjeta

Start of trial: QII 2016

End of trial or status: in preparation

Participating centers: ca. 50

Sample size: 100 (phase II)

Further information: clinicaltrials.gov

RAMSES (FLOT7)

Kurztitel: Perioperative RAMucirumab in combination with FLOT versus FLOT alone for reSEctable eSophagogastric adenocarcinoma – RAMSES – A phase II/III trial of the AIO

Therapie: 4 cycles FLOT - OP - 4 cycles FLOT +/- Ramucirumab

Start of trial: Q2 2016 anticipated

End of trial or status: in preparation

Participating centers: ca. 50

Sample size: 150

Further information: clinicaltrials.gov

QoliXane (AIO-LQ-0214/ass)

Short title: Observational Study on Quality of Life of Patients Receiving Nab-paclitaxel/Gemcitabine First Line Therapy, Including a Translational Program

Therapy: NabPaclitaxel + Gemcitabin

Start of trial: 18. September 2014

End of trial or status: recruiting

Participating centers: 91

Sample size: 600

Further information: clinicaltrials.gov

FerInjekt

Short title: Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.

Therapy: Ferric carboxymaltose parenteral vs. oral iron substitution

Start of trial: 01. April 2015

End of trial or status: recruiting

Participating centers: ca. 20

Sample size: 64 (32 per trial arm)

Further information: clinicaltrials.gov

Nepafox

Short title: Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma

Therapy: Gemcitabine versus neoadjuvant/adjuvant FOLFIRINOX

Start of trial: 01. November 2014

End of trial or status: recruiting

Participating centers: ca. 15

Sample size: 126 (63 per trial arm)

Further information: clinicaltrials.gov

STELLA

Short title: Evaluation of Quality of Life and Period of Hospitalization by Education (STELLA)

Therapy: Special stoma training

Start of trial: 24. November 2015

End of trial or status: recruiting

Participating centers: ca. 5

Sample size: 138

Further information: clinicaltrials.gov

FLAVIA

Short title: Prospective trial on early palliative care integration to oncologic therapy

Therapy: Counseling

Start of trial: 18. June 2015

End of trial or status: recruiting

Participating centers: KHNW

Sample size: 30

Further information: Description (German)

FLOT4

Short title: 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer

Therapy: 4 cycles FLOT - OP - 4 cycles FLOT postoperatively vs. 3 cycles ECX/ECF - OP - 3 cycles ECX/ECF

Start of trial: 01. August 2010

End of trial or status: Recruitment closed since 05. February 2015

Participating centers: ca. 39

Sample size: 714 (357 per trial arm)

Further information: clinicaltrials.gov

RadPac (AIO-STO 0111)

Short title: A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy

Therapy: RAD001 (Everolimus) Paclitaxel

Start of trial: 01. September 2011

End of trial or status: Recruitment closed since 07. September 2015

Participating centers: ca. 40

Sample size: 480 (240 per trial arm)

Further information: clinicaltrials.gov

CabaGast

Short title: Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer

Therapy: Cabazitaxel

Start of trial: 01. September 2013

End of trial or status: Recruitment closed since 12. Ocotber 2015

Participating centers: ca. 16

Sample size: 65

Further information: clinicaltrials.gov