Trial | NCT00407186  Report issue

Title

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

    Phase 3

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    788
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.
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.
Study Started
Jan 11
2007
Primary Completion
Dec 31
2018
Anticipated
Study Completion
Dec 31
2025
Anticipated
Last Update
Oct 10
2017

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)

1chemoradiotherapy Experimental

5 weeksadjuvant treatment; radiotherapy and concomitant chemotherapy with cisplatin and capecitabine.

2chemotherapy Active Comparator

3 adjuvant courses epirubicin, cisplatin, capecitabine.

Criteria 

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
No Results Posted