MedTrace Logo

FLOT vs. FLOT/Herceptin/Pertuzumab for Perioperative Therapy of HER-2 Expressing Gastric or GEJ Cancer

NCT02581462 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2020-08-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

FLOT alone

Pre-operative therapy: * Docetaxel 50 mg/m², d1, d15, d29, d43 * Oxaliplatin 85 mg/m², d1, d15, d29, d43 * Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines) * 5-FU 2600 mg/m², d1, d15, d29, d43 Surgery is recommended to be scheduled 4 weeks after d43. Post-operative therapy (start 6 to 8 weeks after surgery): * Docetaxel 50 mg/m², d1, d15, d29, d43 * Oxaliplatin 85 mg/m², d1, d15, d29, d43 * Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines) * 5-FU 2600 mg/m², d1, d15, d29, d43

BIOLOGICAL

FLOT + Herceptin/Pertuzumab

Pre-operative therapy: * Herceptin 8/6 mg/kg, d1, d22, d43 * Pertuzumab 840 mg, d1, d22, d43 * Docetaxel 50 mg/m², d1, d15, d29, d43 * Oxaliplatin 85 mg/m², d1, d15, d29, d43 * Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines) * 5-FU 2600 mg/m², d1, d15, d29, d43 Surgery is recommended to be scheduled 4 weeks after d43. Post-operative therapy (start 6 to 8 weeks after surgery): * Herceptin 8/6 mg/kg, d1, d22, d43 * Pertuzumab 840 mg, d1, d22, d43 * Docetaxel 50 mg/m², d1, d15, d29, d43 * Oxaliplatin 85 mg/m², d1, d15, d29, d43 * Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines) * 5-FU 2600 mg/m², d1, d15, d29, d43.

Sponsors & Collaborators

  • Trium Analysis Online GmbH

    collaborator INDUSTRY

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah-Eddin Al-Batran, Prof. Dr. · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-07-17
Completion
2020-07-17

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02581462 on ClinicalTrials.gov