Compare Neoadjuvant Chemotherapy of DOS Versus SOX in Locally Advanced Gastric Adenocarcinoma.

NCT03691454 | Unknown Phase 2

• 1 other identifier: CGOG1008
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Adenocarcinoma

Keywords

gastric adenocarcinoma; neoadjuvant chemotherapy; locally advanced; Oxaliplatin; S-1; Docetaxel

Outcome Measures

Primary Outcomes (1)

• The rate of pathologic complete response（pCR%）

  Evaluation of pCR% of DOS regimen versus SOX regimen in locally advanced gastric adenocarcinoma

  1 year

Secondary Outcomes (2)

• Overall Survival : From date of enrollment until the date of death

  5 years

• 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.

  3 years

Study Arms (2)

DOS

EXPERIMENTAL

Docetaxel+Oxaliplatin+S-1

Drug: Docetaxel

SOX

ACTIVE COMPARATOR

Oxaliplatin+S-1

Drug: Oxaliplatin

Interventions

Docetaxel DRUG

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.

Also known as: Oxaliplatin, S-1, Herceptin

DOS

Oxaliplatin DRUG

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.

Also known as: S-1, Herceptin

SOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory males or females with ages ≥ 18.
• Karnofsky performance status ≥ 70%.
• Histologically confirmed gastric adenocarcinoma including Lauren classification and validated overexpression of HER2.
• cTNM should be diagnosed by enhanced CT/MRI (combined with endoscopic ultrasonography and diagnostic laparoscopic exploration) as cIII/IVa according to AJCC 8th classification.
• Radical resection is possible before operation.
• 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).
• Physiological status and organ function are acceptable for major abdominal surgical operation.
• 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.
• Left ventricular ejection fraction evaluated by echocardiac scanning ≥ 50%.
• No severe comorbidity with less than 5 year survival.
• Willing to receive the regimens in this study.
• Sign written informed consent form before screening of study, and can withdraw in any time with no loss.
• Agree to provide blood sample and histological specimen.

You may not qualify if:

• Pregnancy or lactation women.
• 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.
• Sexually active males or females refuse to practice contraception during the study.
• With distant metastasis diagnosed by CT/EUS.
• Underwent prior antitumor treatment including chemotherapy, radiotherapy or immunotherapy except steroid therapy.
• Suffered from other malignant tumors in previous 5 years, with the exception of cured cutaneum carcinoma and cervical carcinoma in situ.
• 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.
• 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.
• Complicated by upper gastrointestinal obstruction or abnormal digestive function or malabsorption syndrome, which may affect the absorption of S-1.
• Known peripheral nervous system disorder ≥ NCI CTC AE 1 grade with the exception of only disappearance of deep tendon reflex (DRT).
• History of organ transplantation with immunosuppression therapy.
• 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)
• Lack of dihydropyrimidine dehydrogenase (DPD).
• Allergic reaction to platinum compounds or other agents used in this study.
• Patients who have received study agents within 4 weeks (participating in other clinical trials).

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

Docetaxel; Oxaliplatin; S 1 (combination); Trastuzumab

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jiafu Ji, Professor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Beijing Cancer Hospital

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: October 1, 2018
• Study Start: June 28, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: October 1, 2018

Record last verified: 2018-09

Locations

CN (1)