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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

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

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Drug: Docetaxel Drug: Oxaliplatin Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DOS
Docetaxel+Oxaliplatin+S-1
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

Active Comparator: SOX
Oxaliplatin+S-1
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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): NCT03691454


Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Jiafu Ji, Professor Beijing Cancer Hospital

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Responsible Party: Shen Lin, Head of Beijing Cancer Hospital, Peking University
ClinicalTrials.gov Identifier: NCT03691454    
Other Study ID Numbers: CGOG1008
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shen Lin, Peking University:
gastric adenocarcinoma
neoadjuvant chemotherapy
locally advanced
Oxaliplatin
S-1
Docetaxel
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Docetaxel
Oxaliplatin
Trastuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological