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A Multicenter Randomized Phase III Trial of Neo-adjuvant Chemotherapy Followed by Surgery and Chemotherapy or by Surgery and Chemoradiotherapy in Resectable Gastric Cancer (CRITICS Study)

Phase 3
18 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

A Multicenter Randomized Phase III Trial of Neo-adjuvant Chemotherapy Followed by Surgery and Chemotherapy or by Surgery and Chemoradiotherapy in Resectable Gastric Cancer (CRITICS Study)

The mainstay of curative treatment of gastric cancer is radical surgical dissection. Because
most patients in the Western world present with advanced stages long term survival is found
in about 25%, with local recurrences as part of treatment failure in up to 80% of cases.
Studies examining the role of more extended lymph node dissections (D1 vs. D2), adjuvant
radiotherapy or adjuvant chemotherapy did not result in a clinical relevant improvement of
survival. In 2001 results of a South West Oncology group (SWOG) trial that randomized
between surgery and surgery with chemoradiotherapy were published. This trial, that was
hampered by suboptimal surgery (less than D1 in majority of patients) and radiotherapy (2D
radiotherapy; 35% protocol deviations) showed an absolute increase in median survival of 9
months. More recently results of the MAGIC study, which randomized between surgery and
surgery plus 6 perioperative courses of ECF chemotherapy, were presented. This regimen
resulted in an absolute 5-year survival benefit of 13% and in a 10% higher resectability

This phase III prospectively randomized study investigates whether chemoradiotherapy (45 Gy
in 5 weeks with daily cisplatin and capecitabine) after preoperative chemotherapy (3x ECC
(epirubicin, cisplatin, capecitabine)) and adequate (D1+) surgery leads to improved survival
in comparison with postoperative chemotherapy (3x ECC). Furthermore, toxicity of both
treatment regimens will be explored.

Inclusion Criteria:

- Ib-IVa (no distant metastases) gastric cancer (histologically proven); tumor bulk in
the stomach

- WHO < 2

- Age ≥18 yrs

- Operable gastric cancer

- No prior abdominal radiotherapy or chemotherapy

- Tumornegative laparoscopy when CT suggests peritoneal carcinomatosis

- Start treatment within 10 working days after registration

- Written informed consent

Exclusion Criteria:

- T1N0 disease (endoscopic ultrasound)

- Distant metastases

- Inoperable patients; due to technical surgery-related factors or general condition

- Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ
cancer of the cervix uteri.

- Solitary functioning kidney that will be within the radiation field

- Major surgery within 4 weeks prior to study treatment start, or lack of complete
recovery from the effects of major surgery

- Uncontrolled (bacterial) infections

- Significant cardiac disorders

- Continuous use of immunosuppressive agents

- Concurrent use of the antiviral agent sorivudine or chemically related analogues

- Hearing loss > CTC grade 1

- Neurotoxicity > CTC grade 1

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

study duration

Safety Issue:


Principal Investigator

Marcel Verheij, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nederlands Kanker Insituut/Antoni van Leeuwenhoek Ziekenhuis


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

December 2006

Completion Date:

December 2013

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • surgery
  • adjuvant
  • chemotherapy
  • chemoradiotherapy
  • capecitabine
  • cisplatin
  • epirubicin
  • Stomach Neoplasms