Stomach Cancer Clinical Trial
Official title:
FLOT vs. FLOT/Herceptin/Pertuzumab for Perioperative Therapy of Adenocarcinoma of the Stomach and Gastroesophageal Junction Expressing HER-2. A Phase II/III Trial of the AIO.
Previous studies provide a strong theoretical rationale for the conduct of a randomized study evaluating the efficacy and safety of Herceptin and pertuzumab in combination with FLOT in the perioperative treatment of resectable HER-2 positive adenocarcinoma of the stomach or GEJ.
This is a multicenter, randomized, controlled, open-label study including patients with
locally advanced adenocarcinoma of the stomach and GEJ scheduled to receive perioperative
chemotherapy. According to centrally assessed HER-2 status: Patients with HER-2 positive
tumors will receive FLOT +/- Herceptin / pertuzumab.
The scope of the phase II portion of the trial is to evaluate pathological response rates of
either regimen assessed by a centralized pathology and define safety and tolerability.
Patients with locally advanced esophagogastric adenocarcinoma (i.e. cT2 any N or any T
N-positive) with exclusion of distant metastases will be included in this trial.
Patients will be stratified by age (18-69 vs. ≥ 70), tumor site (GEJ vs. gastric) and
clinical stage (T1/2 vs. 3/4 and N- vs. N+) and randomized 1:1 to receive either FLOT (Arm A)
or FLOT/Herceptin/pertuzumab (Arm B).
Arm A (control group) Patients randomized to Arm A will receive 4 pre-operative treatments of
FLOT (Docetaxel 50 mg/m², iv over 2 h; Oxaliplatin 85 mg/m² in 500 ml G5%, iv over 2h;
Leucovorin 200 mg/m² in 250 ml NaCl 0.9 %, iv over 1 h; 5-FU 2600 mg/m², iv over 24 h) on d1,
d15, d29, d43 of the preoperative treatment phase. Surgery is recommended to occur 4 weeks
after last FLOT (4 weeks after d43 = day 71). Patients will receive 4 additional
post-operative treatments of FLOT on d1, d15, d29, and d43 of the post-operative treatment
phase. Post-operative treatment should start 6 to 8 weeks, but at maximum 12 weeks after
surgery.
Arm B (Herceptin/pertuzumab group) Patients randomized to Arm B will receive the FLOT regimen
identical to Arm A as described above in conjunction with three-weekly Herceptin at 8mg/kg
initial dose (Day 1, loading dose) followed by subsequent doses of Herceptin at 6mg/kg on d22
and d43 and pertuzumab at 840mg on d1, d22, and d43. Surgery is recommended to occur 4 weeks
after last FLOT/Herceptin/pertuzumab dose (4 weeks after d43 = day 71). Patients will receive
3 additional doses of Herceptin and pertuzumab on d1, d22, and d43 of the post-operative
treatment phase, together with the postoperative chemotherapy. Moreover, patients will
receive 11 additional doses of Herceptin and pertuzumab after the end of post-operative FLOT.
In both of the arms, tumor assessments (CT or MRI) are performed before randomization and
prior to surgery and then every 3 months thereafter until progression/relapse, death or end
of follow-up.
During treatment, clinical visits (blood cell counts, detection of toxicity) occur prior to
every treatment dose. Safety of FLOT/Herceptin/pertuzumab will be monitored continuously by
careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported.
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