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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Lin Chen, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01583361
First received: April 4, 2012
Last updated: April 23, 2012
Last verified: April 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Chinese PLA General Hospital:

Primary Outcome Measures:
  • disease free survival [ Time Frame: three years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 4, 2012
Last Updated: April 23, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014