Planning treatment for oesophago-gastric cancer: a randomised maintenance therapy trial (PLATFORM Trial) - PLATFORM

The Royal Marsden NHS Foundation Trust0 sites770 target enrollmentJuly 24, 2020

Overview

No summary available.

Registry

who.int

Start Date

July 24, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Histologically verified inoperable locally advanced or metastatic adenocarcinoma of the oesophagus, oesophago\-gastric junction, or stomach.
•Completion of at least 6 cycles of first\-line chemotherapy for locally advanced / metastatic disease (this must have included a platinum and fluoropyrimidine in all cases; HER\-2 positive patients must have received trastuzumab alongside chemotherapy) with \> stable disease on the end of treatment CT scan.
•Disease which, following first\-line chemotherapy, remains inoperable and unsuitable for definitive chemoradiotherapy.
•Able to proceed with maintenance treatment within 28 days of the last day of the last cycle of chemotherapy.
•Formalin fixed paraffin embedded (FFPE) blocks of diagnostic tissue available for biomarker analysis.
•Uni\-dimensionally measurable disease (CT or MRI as per RECIST).
•Any prior chemotherapy or radiotherapy in the adjuvant setting must have been completed at least 6 months prior to the first occurrence of metastatic disease.
•No prior radiotherapy in the advanced disease setting. Patients receiving palliative radiotherapy to sites of disease that are not measurable may be eligible and should be discussed with the Chief Investigator.
•Male/female patients aged \=18 years.
•WHO Performance status 0, 1 or 2\.

•Concurrent enrolment in another clinical trial unless it is an observational (non\-interventional) clinical study.
•Tumours of squamous histology.
•Documented brain metastases, central nervous system metastases or leptomeningeal disease.
•Patients who have not recovered from clinically significant effects of any prior surgery, radiotherapy or any other anti\-neoplastic therapies. All toxicities must have resolved to grade 1 or less, with the exception of peripheral neuropathy which must be \< grade 2 according to NCI CTCAE version 4\.0\.
•Any major surgery within 4 weeks prior to the start of study treatment.
•Uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg).
•Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, symptomatic congestive heart failure, uncontrolled cardiac dysrhythmia, or myocardial infarction within the last 12 months. Patients with any prior history of clinically significant cardiac failure are excluded from study entry.
•History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.
•Lack of physical integrity of the upper gastro\-intestinal tract, malabsorption syndrome, or inability to take oral medication.
•Patients who are pregnant or lactating.