JCVU: The RAINFALL Study
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-Line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)
IRAS ID
171812
Contact name
Joanna Warner-Smith
Contact email
Eudract number
2014-002240-40
Duration of Study in the UK
3 years, 7 months, 14 days
Research summary
Gastric and Gastroesphageal junction (GEJ) cancers represent a leading cause of cancer deaths. Gastric cancer is the fifth most common cancer in the world.
Chemotherapy using a fluoropyrimidine containing treatment (which is found in 5-FU and Capecitabine) is usually given to terminally ill patients with this type of cancer as a 'backbone' treatment. It is normally given in combination with another treatment such as Cisplatin or a similar (platinum based) medicine. Gastric cancer patients treated with this current standard treatment regime have an average survival time of between 9 and 11 months.
This study aims to treat patients with Capecitabine (or 5-FU) and Cisplatin and to introduce Ramucirumab as a third experimental medicine.Ramucirumab works to inhibit a process called angiogenesis. Angiogenesis inhibitor treatments are currently being looked at to treat cancers. Angiogenesis is a process through which blood vessels form from pre-existing blood vessels. It is a fundamental step in the transition of tumours from a benign state to a malignant one. Ramucirumab also inhibits vasculogenesis which is another process that can potentially help tumours to grow.
Ramucirumab already has approval in the USA to be used on its own and with another medicine called Paclitaxel to treat patients with gastric cancers if they have already had previous treatment with fluoropyrimidine or a platinum containing treatment.
To be eligible to participate in this study patients must be 18 years old or over and have a diagnosis of Gastric or Gastroesphageal junction (GEJ) cancer.
Study assessments will include: Physical examinations, ECGs, Questionnaire completion, blood and urine tests and radiological scans.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/0448
Date of REC Opinion
14 Apr 2015
REC opinion
Further Information Favourable Opinion