Short summary

Annually, more than 1100 patients are diagnosed with cancer of the esophagus and stomach, often with extensive disease. Many of these patients are offered palliative and life-prolonging chemotherapy. Standard options are few, and there is a great need for new, effective treatment. It has been shown, that a new chemotherapy drug (TAS-102 or Lonsurf) can prolong survival of patients who are previously treated with standard chemotherapy, and new data indicate even better efficacy, when TAS-102 is given in combination (with bevacizumab). We hope to confirm these data in our study, thereby hopefully improving quality of life and prolonging the survival of our patients with esophageal and gastric cancer.

Rationale

The TAGS study introduced TAS-102 in pretreated patients with adenocarcinoma in esophagus and stomach (EGA), thereby introducing a new treatment option. The study resulted in superior survival with a favorable safety profile. Additional data (C-TASK FORCE trial) were also promising, when TAS-102 was combined with bevacizumab, with nearly doubling of the time to disease progression. TAS-102 is not yet approved for patients with refractory EGA, and cannot yet be offered to Danish patients.  We have designed a Danish prospective, randomised study, that will include patients with treatment-resistent metastatic or non-resectable EGA and evaluate TAS-102 as single-agent or in combination with bevacizumab. Furthermore, a biobank (collection of tumour tissue and blood) is planned for future translational research. The study is planned and designed in collaboration with the Danish multidisciplinary group for esophago-gastric cancer, DECV, and will include patients from all Danish centres, that treat patients with metastatic or non-resectable EGA.

Description of the cohort

Adult patients with non-resectable and/or metastatic esophagogastric adenocarcinoma, prior treated with platinum and fluoropyrimidines. 

Data and biological material

A biobank will be established with collected blood samples and archival tumor tissue.

Collaborating researchers and departments

Department of Oncology, Rigshospitalet

• Dr. PhD Lene Bæksgaard

Department of Oncology, Odense University Hospital

• Professor Per Pfeiffer

Department of Oncology, Aalborg University Hospital

• Dr. Mette Yilmaz, 

Department of Oncology, Aarhus University Hospital

• Dr. PhD Marianne Nordsmark, 

Department of Clinical Genetics, Odense University Hospital

• Professor Torben A. Kruse,

Department of Oncology, Herlev Hospital

• Professor Julia Johansen

Publications associated with the project

The study will be published, once it is completed and the final analysis has been performed.