Annals of Surgical Oncology

, Volume 24, Issue 8, pp 2252–2258 | Cite as

TOPGEAR: A Randomized, Phase III Trial of Perioperative ECF Chemotherapy with or Without Preoperative Chemoradiation for Resectable Gastric Cancer: Interim Results from an International, Intergroup Trial of the AGITG, TROG, EORTC and CCTG

  • Trevor Leong
  • B. Mark Smithers
  • Karin Haustermans
  • Michael Michael
  • Val Gebski
  • Danielle Miller
  • John Zalcberg
  • Alex Boussioutas
  • Michael Findlay
  • Rachel L. O’Connell
  • Jaclyn Verghis
  • David Willis
  • Tomas Kron
  • Melissa Crain
  • William K. Murray
  • Florian Lordick
  • Carol Swallow
  • Gail Darling
  • John Simes
  • Rebecca Wong
Gastrointestinal Oncology

Abstract

Background

Postoperative chemoradiation and perioperative chemotherapy using epirubicin/cisplatin/5-fluorouracil (ECF) represent two standards of care for resectable gastric cancer. In the TOPGEAR (Trial Of Preoperative therapy for Gastric and Esophagogastric junction AdenocaRcinoma) trial, we hypothesized that adding preoperative chemoradiation to perioperative ECF will improve survival; however, the safety and feasibility of preoperative chemoradiation have yet to be determined.

Methods

TOPGEAR is an international phase III trial in which patients with adenocarcinoma of the stomach were randomized to perioperative ECF alone or with preoperative chemoradiation. The ECF-alone group received three preoperative cycles of ECF, while the chemoradiation group received two cycles of preoperative ECF followed by chemoradiation. Both groups received three postoperative cycles of ECF. A planned interim analysis of the first 120 patients was conducted, and was reviewed by the Independent Data Safety Monitoring Committee to assess treatment compliance, toxicity/safety, and response rates.

Results

The proportion of patients who received all cycles of preoperative chemotherapy was 93% (ECF group) and 98% (chemoradiation group), while 65 and 53%, respectively, received all cycles of postoperative chemotherapy. Overall, 92% of patients allocated to preoperative chemoradiation received this treatment. The proportion of patients proceeding to surgery was 90% (ECF group) and 85% (chemoradiation group). Grade 3 or higher surgical complications occurred in 22% of patients in both groups. Furthermore, grade 3 or higher gastrointestinal toxicity occurred in 32% (ECF group) and 30% (chemoradiation group) of patients, while hematologic toxicity occurred in 50 and 52% of patients.

Conclusions

These results demonstrate that preoperative chemoradiation can be safely delivered to the vast majority of patients without a significant increase in treatment toxicity or surgical morbidity.

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Copyright information

© Society of Surgical Oncology 2017

Authors and Affiliations

  • Trevor Leong
    • 1
  • B. Mark Smithers
    • 2
  • Karin Haustermans
    • 3
  • Michael Michael
    • 1
  • Val Gebski
    • 4
  • Danielle Miller
    • 4
  • John Zalcberg
    • 5
  • Alex Boussioutas
    • 1
  • Michael Findlay
    • 6
  • Rachel L. O’Connell
    • 4
  • Jaclyn Verghis
    • 4
  • David Willis
    • 7
  • Tomas Kron
    • 1
  • Melissa Crain
    • 8
  • William K. Murray
    • 1
  • Florian Lordick
    • 9
  • Carol Swallow
    • 10
  • Gail Darling
    • 11
  • John Simes
    • 4
  • Rebecca Wong
    • 12
  1. 1.Peter MacCallum Cancer CentreMelbourneAustralia
  2. 2.Upper Gastrointestinal and Soft Tissue Unit, School of Medicine, Princess Alexandra HospitalUniversity of QueenslandWoolloongabbaAustralia
  3. 3.Radiation Oncology, University Hospitals Leuven, Department of OncologyKU LeuvenLeuvenBelgium
  4. 4.NHMRC Clinical Trials CentreUniversity of SydneyCamperdownAustralia
  5. 5.School of Public Health and Preventive MedicineMonash UniversityMelbourneAustralia
  6. 6.Faculty of Medical and Health SciencesUniversity of AucklandGraftonNew Zealand
  7. 7.North West Cancer CentreNEMSCTamworthAustralia
  8. 8.TROG Cancer Researchc/o Calvary Mater Newcastle, HRMCWaratahAustralia
  9. 9.University Cancer Center Leipzig (UCCL)University Medicine LeipzigLeipzigGermany
  10. 10.Mount Sinai HospitalTorontoCanada
  11. 11.Toronto General HospitalTorontoCanada
  12. 12.Princess Margaret HospitalTorontoCanada

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