Randomized Phase III Trial of Adjuvant Chemotherapy or Chemoradiotherapy in Resectable Gastric Cancer (CRITICS)

Gastric Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00407186
• Other study ID #: CRITICS
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 1, 2006
• Last updated: October 9, 2017
• Start date: January 11, 2007
• Est. completion date: December 2025

Study information

• Verified date: October 2017
• Source: Dutch Colorectal Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of combined chemotherapy and radiotherapy (in comparison to chemotherapy alone) as adjuvant treatment after surgery for gastric cancer. Prior to surgery all patients will receive neo-adjuvant chemotherapy as well.

Description:

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 rate.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 788
• Est. completion date: December 2025
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• cisplatin+capecitabine
cisplatin 20 mg/m2 (i.v., q 1 w, 5 weeks), capecitabine 575 mg/m2 (b.i.d., oral, on radiotherapy days.

Radiation:
• radiotherapy
45 Gy in 25 fracions (5 days/week)

Drug:
• epirubicin+cisplatin+capecitabine
3 courses q 3 w: epirubicin 50 mg/m2 (i.v., day 1), cisplatin 60 mg/m2 (i.v., day 1), capecitabine 1000 mg/m2 (b.i.d., oral, day 1-14)

Locations

Country	Name	City	State
Netherlands	Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis	Amsterdam

Sponsors (3)

Lead Sponsor	Collaborator
Dutch Colorectal Cancer Group	Roche Pharma AG, The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		study duration
Secondary	disease-free survival		study duration
Secondary	toxicity		study duration
Secondary	health-related quality of life		study duration

External Links

•   Dutch Colorectal Cancer Group
•   Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis (Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital)