Randomized Phase III Trial of Adjuvant Chemotherapy or Chemoradiotherapy in Resectable Gastric Cancer (CRITICS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: cisplatin+capecitabine Radiation: radiotherapy Drug: epirubicin+cisplatin+capecitabine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
- overall survival [ Time Frame: study duration ] [ Designated as safety issue: No ]
- disease-free survival [ Time Frame: study duration ] [ Designated as safety issue: No ]
- toxicity [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
- health-related quality of life [ Time Frame: study duration ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 788 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1chemoradiotherapy
5 weeksadjuvant treatment; radiotherapy and concomitant chemotherapy with cisplatin and capecitabine.
|
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)
|
|
Active Comparator: 2chemotherapy
3 adjuvant courses epirubicin, cisplatin, capecitabine.
|
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)
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Marcel Verheij, MD PhD | 020-5122124 | rsc@rsconsultancy.nl |
| Contact: Raymond J. Schmidt, MD | 0575-441001 | rsc@rsconsultancy.nl |
| Netherlands | |
| Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis | Recruiting |
| Amsterdam, Netherlands, 1066 CX | |
| Contact: Marcel Verheij, MD PhD 020-5122124 m.verheij@nki.nl | |
| Contact: Annemieke 020-5122566 a.cats@nki.nl | |
| Principal Investigator: Marcel Verheij, MD PhD | |
| Principal Investigator: | Marcel Verheij, MD PhD | Nederlands Kanker Insituut/Antoni van Leeuwenhoek Ziekenhuis |
More Information
Additional Information:
No publications provided by Dutch Colorectal Cancer Group
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M. Verheij MD PhD, DCCG |
| ClinicalTrials.gov Identifier: | NCT00407186 History of Changes |
| Other Study ID Numbers: | CRITICS |
| Study First Received: | December 1, 2006 |
| Last Updated: | August 27, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Dutch Colorectal Cancer Group:
|
CRITICS gastric cancer surgery adjuvant chemotherapy |
chemoradiotherapy capecitabine cisplatin epirubicin |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Adjuvants, Immunologic Capecitabine Cisplatin Epirubicin |
Fluorouracil Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Antibiotics, Antineoplastic Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents |
ClinicalTrials.gov processed this record on June 13, 2013