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Compare Neoadjuvant Chemotherapy of DOS Versus SOX in Locally Advanced Gastric Adenocarcinoma. (RESOLVE-2)

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.
 
ClinicalTrials.gov Identifier: NCT03691454
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Tracking Information
First Submitted Date  ICMJE September 11, 2018
First Posted Date  ICMJE October 1, 2018
Last Update Posted Date October 1, 2018
Actual Study Start Date  ICMJE June 28, 2018
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
The rate of pathologic complete response(pCR%) [ Time Frame: 1 year ]
Evaluation of pCR% of DOS regimen versus SOX regimen in locally advanced gastric adenocarcinoma
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • Overall Survival : From date of enrollment until the date of death [ Time Frame: 5 years ]
    Evaluation of the Overall Survival of DOS regimen versus SOX regimen in locally advanced gastric adenocarcinoma
  • Progression-free Survival:From date of enrollment until the date of first documented progression or second gastric cancer or death from any cause, whichever came first. [ Time Frame: 3 years ]
    Evaluation of the Progression-free Survival of DOS regimen versus SOX regimen in locally advanced gastric adenocarcinoma
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare Neoadjuvant Chemotherapy of DOS Versus SOX in Locally Advanced Gastric Adenocarcinoma.
Official Title  ICMJE A Randomized, Multicenter, Controlled, Adaptive II/III Study to Compare Neoadjuvant Chemotherapy of Docetaxel,Oxaliplatin Combined With S-1(DOS) Versus Oxaliplatin Combined With S-1(SOX)in Locally Advanced Gastric Adenocarcinoma (RESOLVE-2 Study)
Brief Summary This is a randomized, multicenter, controlled, adaptive phase II/III clinical study. The aim is to compare neoadjuvant chemotherapy of Docetaxel,Oxaliplatin combined with S-1(DOS) versus Oxaliplatin combined with S-1(SOX) in locally advanced gastric adenocarcinoma
Detailed Description This trial is conducted in patients with locally advanced gastric adenocarcinoma. Eligible patients are randomized into two arms at 1:1 ratio to receive Docetaxel, Oxaliplatin combined with S-1(DOS) for 4 cycles or Oxaliplatin combined with S-1(SOX) for 3 cycles as neoadjuvant chemotherapy. All eligible patients will receive D2 gastrectomy if possible. Then, all eligible patients will also received DOS for 4 cycles or SOX for 3 cycles within 8 weeks after surgery. Study evaluation time is until death of patients or deadline set by the researchers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Adenocarcinoma
Intervention  ICMJE
  • Drug: Docetaxel
    Docetaxel 50mg/m2, intravenous drip, D1, combined with Oxaliplatin 85mg/m2,intravenous drip 2h,D1 and S-1 40-60mg bid(BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid),D1-7;For patients with Her2 positive, add Herceptin 4mg/kg(6mg/kg first cycle) D1; every 14 days for a cycle.
    Other Names:
    • Oxaliplatin
    • S-1
    • Herceptin
  • Drug: Oxaliplatin
    Oxaliplatin 130mg/m2,intravenous drip 2h,D1 combined with S-1 40-60mg bid(BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid),D1-14;For patients with Her2 positive, add Herceptin 6mg/kg(8mg/kg first cycle) D1; every 21 days for a cycle.
    Other Names:
    • S-1
    • Herceptin
Study Arms  ICMJE
  • Experimental: DOS
    Docetaxel+Oxaliplatin+S-1
    Intervention: Drug: Docetaxel
  • Active Comparator: SOX
    Oxaliplatin+S-1
    Intervention: Drug: Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2018)
258
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ambulatory males or females with ages ≥ 18.
  2. Karnofsky performance status ≥ 70%.
  3. Histologically confirmed gastric adenocarcinoma including Lauren classification and validated overexpression of HER2.
  4. cTNM should be diagnosed by enhanced CT/MRI (combined with endoscopic ultrasonography and diagnostic laparoscopic exploration) as cIII/IVa according to AJCC 8th classification.
  5. Radical resection is possible before operation.
  6. Research center and surgeons have the ability of conducting D2 lymphadenectomy (more than 15 lymph glands should be checked to ensure the quality of operation).
  7. Physiological status and organ function are acceptable for major abdominal surgical operation.
  8. Baseline blood routine and biochemical indexes of patients enrolled should meet criteria below: hemoglobin ≥ 90g/L, absolute neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 100×10⁹/L, aspartate or alanine aminotransferase ≤ 2.5 times the upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the ULN, total serum bilirubin < 1.5 times the ULN, serum creatinine < 1 time ULN, Serum albumin ≥ 30g/L.
  9. Left ventricular ejection fraction evaluated by echocardiac scanning ≥ 50%.
  10. No severe comorbidity with less than 5 year survival.
  11. Willing to receive the regimens in this study.
  12. Sign written informed consent form before screening of study, and can withdraw in any time with no loss.
  13. Agree to provide blood sample and histological specimen.

Exclusion Criteria:

  1. Pregnancy or lactation women.
  2. Woman of childbearing age was not tested in baseline pregnancy test or tested positve. Postmenopausal women with amenorrhea for at least 12 months are considered nonpregnancy.
  3. Sexually active males or females refuse to practice contraception during the study.
  4. With distant metastasis diagnosed by CT/EUS.
  5. Underwent prior antitumor treatment including chemotherapy, radiotherapy or immunotherapy except steroid therapy.
  6. Suffered from other malignant tumors in previous 5 years, with the exception of cured cutaneum carcinoma and cervical carcinoma in situ.
  7. Patients with uncontrolled seizure, central nervous system disorder or psychiatric disease will be judged by researchers whether severity influences signing informed consent or compliance to take medicine.
  8. Suffered from severe cardiovascular diseases such as symptomatic coronary heart disease, congestive heart failure ≥ II grade according to NYHA (New York Heart Association) standard, uncontrolled cardiac arrhythmia, cardiac infarction within 12 months prior to study enrollment.
  9. Complicated by upper gastrointestinal obstruction or abnormal digestive function or malabsorption syndrome, which may affect the absorption of S-1.
  10. Known peripheral nervous system disorder ≥ NCI CTC AE 1 grade with the exception of only disappearance of deep tendon reflex (DRT).
  11. History of organ transplantation with immunosuppression therapy.
  12. Complicated with severe uncontrolled concurrent infection or other severe uncontrolled concominant diseases, moderate or severe kidney injury (creatinine clearance rate ≤ 50 ml/min according to Cockcroft and Gault formula), or serum creatinine serum > the upper limit of normal (ULN)
  13. Lack of dihydropyrimidine dehydrogenase (DPD).
  14. Allergic reaction to platinum compounds or other agents used in this study.
  15. Patients who have received study agents within 4 weeks (participating in other clinical trials).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03691454
Other Study ID Numbers  ICMJE CGOG1008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Shen Lin, Peking University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Peking University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jiafu Ji, Professor Peking University Cancer Hospital & Institute
PRS Account Peking University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP