Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial

Conditions

• Adenocarcinoma of the Gastro-oesophageal Junction
• Adenocarcinoma of the Oesophagus
• Adenocarcinoma of the Stomach

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Capecitabine — DRUG
  1250 mg/m2/day, 21 day cycle
• MEDI4736 (Durvalumab) — DRUG
  IV treatment on days 1\&15 of 28 day cycle
• Trastuzumab — DRUG
  6mg/kg on day 1 cycle every 21 days
• Rucaparib — DRUG
  600mg PO twice daily
• Ramucirumab — DRUG
  ramucirumab 8mg/kg IV day 1 and day 8

Study Details

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.

Key Dates

Start date

Feb 28, 2015

Status verified

Jun 2025

Primary completion

Apr 17, 2025

Completion

Jun 30, 2027

Study Design

Enrollment

494 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: A1: Surveillance
  Patients in this Arm will follow current UK standard of care for this setting and will be reviewed every 4 weeks
• Experimental: Arm A2: Capecitabine Maintenance
  1250 mg/M2/DAY on days 1-21
• Experimental: Arm A3: MEDI4736 (Durvalumab)
  IV treatment on day 1 +15, on a 28 day cycle.
• Active Comparator: Arm B1: Trastuzumab Maintenance
  6mg/kg on day 1 every 21 days
• Experimental: Arm A4: Rucaparib
  600mg PO twice daily
• Experimental: Arm A5: Capecitabine and Ramucirumab
  capecitabine 1250 mg/m2/day PO in two divided doses continuously from days 1-21 of each 21 day cycle (see section 12) and ramucirumab 8mg/kg IV day 1 and day 8

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 5 years ]