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SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer (RESONANCE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Lin Chen, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01583361
First Posted: April 24, 2012
Last Update Posted: April 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lin Chen, Chinese PLA General Hospital
  Purpose

This is a randomized, multicenter, controlled trial to prove efficacy of S‐1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy.

The primary endpoint is three-year free disease and the second primary includes five-year overall survival, safety and R0 resection rate.


Condition Intervention Phase
Gastric Adenocarcinoma Drug: Oxaliplatin+S-1 Drug: Adjuvant Oxaliplatin/S-1(SOX) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III, Randomized, Multicenter, Controlled Evaluation of S‐1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients

Resource links provided by NLM:


Further study details as provided by Lin Chen, Chinese PLA General Hospital:

Primary Outcome Measures:
  • disease free survival [ Time Frame: three years ]
    SOX regimen as Neoadjuvant chemotherapy for AJCC II-III gastric cancer patients is superior than postoperative SOX after D2 surgery.Disease free survival is defined as time of surgery to recurrence or death.


Secondary Outcome Measures:
  • response rate [ Time Frame: 3 months ]
    For neoadjuvant chemotherapy patients,response rate will be evaluated according to RECIST 1.1 criteria after at least 2 cycles of SOX chemotherapy.CT scan is required to every patient.

  • overall survival [ Time Frame: five years ]
    Neoadjuvant chemotherapy of SOX is superior than postoperative SOX after D2 dissection in AJCC II-III gastric cancer patients.Overall survival is defined as the time of randomization to death.

  • safety [ Time Frame: six months ]
    Number of participants with adverse events related to SOX chemotherapy.All adverse events are from CTCAE 4.0 criteria.


Estimated Enrollment: 772
Study Start Date: March 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A:Neoadjuvant sox
Patients in arm a will receive (N=2-4) cycles of neoadjuvant SOX first, and then standard gastrectomy with D2 lymphadenectomy, and (8-N) cycles of adjuvant SOX adjuvant chemotherapy.
Drug: Oxaliplatin+S-1
S-1: 40~60mg bid,po, d1~14 (S-1:BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) oxaliplatin:130mg/m2,iv drip for 2h,d1
Other Names:
  • Oxaliplatin(Sanofi-aventis)
  • S-1(Taiho)
Active Comparator: Arm B:Adjuvant SOX
Patients in arm B will receive standard gastrectomy with D2 Lymphadenectomy first, and 8 cycles of adjuvant SOX later.
Drug: Adjuvant Oxaliplatin/S-1(SOX)
S-1:40~60mg bid,d1~14 q3W oxaliplatin:130mg/m2,iv drip for 2h,d1,q3W 8 cycles (6 months)
Other Names:
  • Oxaliplatin(Sanofi-aventis)
  • S-1(Taiho)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed gastric adenocarcinoma
  2. Gastroesophageal junction tumour type II or III(NCCN 2009) can be enrolled
  3. All patients must undergo EUS,CT(or PET-CT) and laparoscopy to evaluate tumor stage classification (TNM), and only stage II or III (AJCC 7th) gastric cancer patients can be enrolled
  4. planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
  5. KPS > 60; ECOG performance status 0-2
  6. Life expectancy > 6 months
  7. Age: 20 to 75 years
  8. No other severe disease and life expectancy less than five years
  9. 7 days before enrolled, baseline data should be finished including:

    • Granulocyte count ≥ 1.5×109/L;
    • platelet count ≥ 100×109/L;
    • Hemoglobin ≥ 90g/L;
    • hepatic < 1.5×ULN;
    • total bilirubin ≤ 1.0×ULN;
    • creatinine < 1.5×ULN;
    • PT-INR/PTT < 1.7× ULN
  10. Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria
  11. Written informed consent and able to comply with the protocol

Exclusion Criteria:

  1. Patient cannot undergo surgery or chemotherapy because of other severe disease
  2. Be allergic to chemotherapy drugs
  3. Patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled
  4. Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer
  5. Within the last 5 years in patients with a history of other malignant diseases
  6. Pregnant or breast-feeding women
  7. Severe heart disease like symptoms of coronary heart disease, New York Heart Association (NYHA) grade II or worse congestive heart failure or cardiac arrhythmia having medications or myocardial infarction within the last 12 months
  8. Patients with upper gastrointestinal obstruction or absorption anomaly; patient in obstruction of the Helicobacter pylori failure like effect S-1 to take and absorb
  9. Patients with a history of peripheral nerve disease
  10. Patients who get organ transplant
  11. lack of dihydropyrimidine dehydrogenase (DPD)
  12. Infection or other disease failure to control
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583361


Contacts
Contact: Tao Li, MD,PhD 86-10-66938328 litbj301@sina.com

Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Tao Li, MD,PhD    0086-10-66938328    litbj301@sina.com   
Sponsors and Collaborators
Lin Chen
  More Information

Responsible Party: Lin Chen, Chief of GI Surgeon, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01583361     History of Changes
Other Study ID Numbers: LCHEN-PLAGH
First Submitted: April 4, 2012
First Posted: April 24, 2012
Last Update Posted: April 24, 2012
Last Verified: April 2012

Keywords provided by Lin Chen, Chinese PLA General Hospital:
two arms
D2 lymphadenectomy
chemotherapy before and after surgery
disease free survival

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents