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

NCT01583361 | Unknown Phase 3 DMC

• 1 other identifier: LCHEN-PLAGH
• Study Type: interventional
• Target: 772
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Adenocarcinoma

Keywords

two arms; D2 lymphadenectomy; chemotherapy before and after surgery; disease free survival

Outcome Measures

Primary Outcomes (1)

• disease free survival

  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.

  three years

Secondary Outcomes (3)

• response rate

  3 months

• overall survival

  five years

• safety

  six months

Study Arms (2)

Arm A:Neoadjuvant sox

EXPERIMENTAL

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

Arm B:Adjuvant SOX

ACTIVE COMPARATOR

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）

Interventions

Oxaliplatin+S-1 DRUG

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

Also known as: Oxaliplatin(Sanofi-aventis), S-1(Taiho)

Arm A:Neoadjuvant sox

Adjuvant Oxaliplatin/S-1（SOX） DRUG

S-1：40\~60mg bid，d1\~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W 8 cycles (6 months)

Also known as: Oxaliplatin(Sanofi-aventis), S-1(Taiho)

Arm B:Adjuvant SOX

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed gastric adenocarcinoma
• Gastroesophageal junction tumour type II or III(NCCN 2009) can be enrolled
• 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
• planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
• KPS \> 60; ECOG performance status 0-2
• Life expectancy \> 6 months
• Age: 20 to 75 years
• No other severe disease and life expectancy less than five years
• 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;

You may not qualify if:

• Patient cannot undergo surgery or chemotherapy because of other severe disease
• Be allergic to chemotherapy drugs
• Patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled
• Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer
• Within the last 5 years in patients with a history of other malignant diseases
• Pregnant or breast-feeding women
• 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
• Patients with upper gastrointestinal obstruction or absorption anomaly; patient in obstruction of the Helicobacter pylori failure like effect S-1 to take and absorb
• Patients with a history of peripheral nerve disease
• Patients who get organ transplant
• lack of dihydropyrimidine dehydrogenase (DPD)
• Infection or other disease failure to control

Sponsors & Collaborators

• Lin Chen: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

• Wang X, Lu C, Wei B, Li S, Li Z, Xue Y, Ye Y, Zhang Z, Sun Y, Liang H, Li K, Zhu L, Zheng Z, Zhou Y, He Y, Li F, Wang X, Liang P, Huang H, Li G, Shen X, Ji J, Tang Y, Xu Z, Chen L; RESONANCE study group. Perioperative versus adjuvant S-1 plus oxaliplatin chemotherapy for stage II/III resectable gastric cancer (RESONANCE): a randomized, open-label, phase 3 trial. J Hematol Oncol. 2024 Apr 8;17(1):17. doi: 10.1186/s13045-024-01536-7.

  PMID: 38589926 DERIVED

Central Study Contacts

Tao Li, MD,PhD

CONTACT

86-10-66938328; litbj301@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of GI Surgeon

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 24, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2017
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

CN (1)