Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial (PLATFORM)
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- STATUS
- Recruiting
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- End date
- Jun 23, 2025
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- participants needed
- 924
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- sponsor
- Royal Marsden NHS Foundation Trust
Summary
To evaluate the efficacy of maintenance therapies following completion of standard first-line chemotherapy in patients with locally advanced or metastatic HER-2 positive or HER-2 negative oesophago-gastric adenocarcinomas.
Description
This is a prospective, open label, multicentre, randomised phase II clinical trial. An adaptive trial design is proposed to allow ineffective treatments to be discontinued early, and to potentially add novel treatment arms as the trial progresses.
Patients will initially receive standard chemotherapy for their locally advanced or metastatic oesophago-gastric adenocarcinoma, according to local practice based upon their HER-2 status (tested locally). In order to be eligible for trial entry, HER-2 negative patients should have received a platinum-fluoropyrimidine based chemotherapy doublet or triplet (Arm A), whilst HER-2 positive patients (IHC 3+ or IHC 2+ and FISH positive) should have received cisplatin in combination with either capecitabine or 5-FU (CX or CF) plus trastuzumab chemotherapy (Arm B). Potentially eligible patients will be registered with the trials office whilst undergoing first line chemotherapy.
Patients will then become eligible for trial recruitment and randomization following completion of at least 6 cycles of standard chemotherapy with SD (stable disease) or better on the end-of-treatment CT scan. Eligible patients will then be randomised according to HER-2 status as follows:
- HER-2 positive patients (~20%) will be currently not be randomised and will be assigned maintenance single-agent trastuzumab (current UK standard), a comparator arm is in development.
- HER-2 negative patients (~80%) will be randomised in a 1:1:1 fashion between surveillance only (current UK standard), maintenance capecitabine, or maintenance immuno-modulatory therapy (anti-PD-L1 antibody)
Patients will be stratified according to: locally advanced disease versus metastatic disease, and performance status (0 versus 1 versus 2).
Review of patients will occur every 4 weeks in the observation only arm. In maintenance therapy arms, patients will be reviewed every 3 or every 4 weeks depending upon the treatment strategy. CT assessments of response will occur every 12 weeks (3 months) in all arms of the trial. Treatment will be continued indefinitely until the occurrence of either disease progression, unacceptable toxicity, or patient withdrawal for another reason.
The trial is being run from the RMH GI clinical trials unit with Professor David Cunningham as the over-arching CI. Effective arms in the phase II portion of the trial may be taken forward into a phase III maintenance trial powered for overall survival. It is also hoped that, as more robust data becomes available for other biomarker-selected populations (e.g. MET-positive, FGFR-amplified), it may be possible to amend the overall trial design to incorporate these biomarker-targeted maintenance therapies in the HER-2 negative population.
Details
| Condition | Adenocarcinoma of the Oesophagus, Adenocarcinoma of the Gastro-oesophageal Junction, Adenocarcinoma of the Stomach |
|---|---|
| Treatment | Capecitabine, Trastuzumab, MEDI4736, Ramucirumab, rucaparib |
| Clinical Study Identifier | NCT02678182 |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Last Modified on | 26 January 2022 |
Eligibility
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