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

NCT ID: NCT01583361

Last Updated: 2012-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 772 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxaliplatin+S-1

Intervention Type: 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

Arm B:Adjuvant SOX

Patients in arm B will receive standard gastrectomy with D2 Lymphadenectomy first, and 8 cycles of adjuvant SOX later.

Group Type: ACTIVE_COMPARATOR

Adjuvant Oxaliplatin/S-1（SOX）

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

Oxaliplatin(Sanofi-aventis); S-1(Taiho); Oxaliplatin(Sanofi-aventis); S-1(Taiho)

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lin Chen

OTHER

Sponsor Role: lead

Responsible Party

Lin Chen

Chief of GI Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tao Li, MD,PhD

Role: CONTACT

litbj301@sina.com

86-10-66938328

Facility Contacts

Tao Li, MD,PhD

Role: primary

litbj301@sina.com

0086-10-66938328

References

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.

Reference Type: DERIVED

PMID: 38589926 (View on PubMed)

Other Identifiers

LCHEN-PLAGH

Identifier Type: -

Identifier Source: org_study_id