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Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer (RESONANCE-II)

Primary Purpose

Gastric Cancer, Chemotherapy Effect

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Chemotherapy drug
Gastrectomy
Laparoscopic exploration
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Non-bedridden, aged 18 to 70 years old;
  2. Eastern Cooperative Oncology Group (ECOG) score is 0 to 1;
  3. Histologically confirmed gastric adenocarcinoma;
  4. Stage III (American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) gastric cancer confirmed by enhanced computer tomography (enhanced CT) and laparoscopic exploration (endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) if necessary);
  5. The research center and the surgeon have the ability to complete standard D2 radical gastrectomy, and the gastrectomy can be tolerated by the patient;
  6. Laboratory test criteria: peripheral blood hemoglobin (Hb) ≥ 90 g/L, neutrophil absolute count ≥ 3×109 /L, platelet count (PLT) ≥ 100×109 /L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN, serum creatinine (SCr) ≤ 1.5×ULN, and serum albumin (ALB) ≥ 30 g/L;
  7. Patients with heart disease, the echocardiogram showed that the left ventricular ejection fraction ≥ 50%, the electrocardiogram (ECG) is basically normal within 4 weeks before operation and without no obvious symptoms are acceptable;
  8. There is no serious underlying disease that could lead to an expected life expectancy < 5 years;
  9. Willing to sign the inform consent for participation and publication of results.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Positive pregnancy test for women in childbearing age. Menopausal women without menstruation for at least 12 months can be regarded as women with no possibility of getting pregnant;
  3. Refuse to birth control during the study;
  4. Received any chemotherapy, radiotherapy or immunotherapy before;
  5. History of other malignant diseases in the last five years (except for cervical carcinoma in situ);
  6. History of uncontrolled central nervous system diseases, which could influence the compliance;
  7. History of severe liver diseases, renal diseases or respiratory diseases; Uncontrolled diabetes and hypertension; Clinically severe heart disease, such as congestive heart failure, symptomatic coronary heart disease, uncontrolled arrhythmia, or a history of myocardial infarction in the last six months;
  8. History of dysphagia, complete or partial gastrointestinal obstruction, active gastrointestinal bleeding and gastrointestinal perforation;
  9. On steroid treatment after organ transplant;
  10. With uncontrolled severe infections;
  11. Known dihydropyrimidine dehydrogenase deficiency (DPD);
  12. Anaphylaxis to any research drug ingredient;
  13. Known peripheral neuropathy (> NCI-CTC AE 1). Patients with only disappearance of deep tendon reflex need not to be excluded.

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Patients will be pre-enrolled and receive three cycles of SOX. After randomization, patients in Arm A will receive three more cycles of SOX (six cycles of neoadjuvant chemotherapy with SOX in total) followed by D2 gastrectomy.

Patients will be pre-enrolled and receive three cycles of SOX. After randomization, patients in Arm B will receive D2 gastrectomy (three cycles of neoadjuvant chemotherapy with SOX in total).

Outcomes

Primary Outcome Measures

pCR rate
The pCR rate is defined as the rate of patients achieving pCR.

Secondary Outcome Measures

R0 resection rate
The R0 resection rate is defined as the rate of R0 resection.
Three-year disease-free survival
The DFS is defined as the period from the time of surgery to recurrence or death.
Five-year overall survival
The OS is defined as the period from the time of surgery to death or last follow-up.

Full Information

First Posted
July 19, 2020
Last Updated
January 17, 2021
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04483076
Brief Title
Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer
Acronym
RESONANCE-II
Official Title
A Prospective, Multicenter, Randomized, Controlled Phase III Study Evaluating Different Cycles of Oxaliplatin Combined With S-1 (SOX) as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: RESONANCE-II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RESONANCE-II trial is a prospective, multicenter, randomized, controlled phase III study which will enroll 524 patients in total. Patients with eligibility will be registered, pre-enrolled and receive three cycles of SOX. Then, tumor response evaluation will be carried out. Those who achieve stable disease or progressive disease will be excluded. Patients achieving complete response or partial response will be enrolled and assigned into either group A for another three cycles of SOX (six cycles in total) followed by D2 surgery and group B for D2 surgery (three cycles in total). The primary endpoint is the rate of pathological complete response and the secondary endpoints are R0 resection rate, three-year disease-free survival, five-year overall survival and safety.
Detailed Description
RESONANCE-II trial is a prospective, multicenter, randomized, controlled phase III study which was designed to evaluate the efficacy and safety of different cycles of SOX as neoadjuvant chemotherapy for patients with locally advanced gastric cancer. All patients with eligibility will be registered, pre-enrolled and receive three cycles of SOX. Then, tumor response evaluation will be carried out according to the Response Evaluation Criteria for Solid Tumors (RECIST) 1.1. Those who achieve stable disease (SD) or progressive disease (PD)will be excluded. Patients achieving complete response (CR) or partial response (PR) will be enrolled and assigned into either group A (six cycles of neoadjuvant chemotherapy with SOX) for another three cycles of SOX followed by D2 surgery and group B (three cycles of neoadjuvant chemotherapy with SOX) for D2 surgery. The primary endpoint is the rate of pathological complete response (pCR%) and the secondary endpoints are R0 resection rate, three-year disease-free survival (3-y DFS), five-year overall survival (5-y OS) and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Chemotherapy Effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
524 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Patients will be pre-enrolled and receive three cycles of SOX. After randomization, patients in Arm A will receive three more cycles of SOX (six cycles of neoadjuvant chemotherapy with SOX in total) followed by D2 gastrectomy.
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Patients will be pre-enrolled and receive three cycles of SOX. After randomization, patients in Arm B will receive D2 gastrectomy (three cycles of neoadjuvant chemotherapy with SOX in total).
Intervention Type
Drug
Intervention Name(s)
Chemotherapy drug
Intervention Description
The preoperative SOX chemotherapy consists of three-week cycles of intravenously administered oxaliplatin 130 mg/m2 on day 1 and orally administered S-1 40-60 mg twice a day (BID) on day 1 to 14. The dose of S-1 depends on body surface area (BSA): 40mg BID for BSA < 1.25 m2; 50mg BID for 1.25 m2 < BSA <1.5 m2; 60mg BID for BSA > 1.5 m2. Day 15 to day 21 is the rest period.
Intervention Type
Procedure
Intervention Name(s)
Gastrectomy
Intervention Description
Surgery is planned 3-4 weeks after the last cycle of chemotherapy. A standard D2 radical laparoscopic gastrectomy is recommended. The extent of gastric resection and lymphadenectomy were performed as per the treatment guidelines. Reconstruction after gastrectomy was decided by the surgeon. All operations are performed by well trained and experienced surgical team to guarantee the quality of surgery, including harvesting more than 16 lymph nodes.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic exploration
Intervention Description
Laparoscopic exploration is to detect occult peritoneal metastases and inspect the primary lesion, liver, diaphragm, pelvic organs, bowel and omentum according to the standard acquirements reported before. Patients with any patterns of distant metastases, suggestive of distant metastasis (M1), will be excluded from the trial.
Primary Outcome Measure Information:
Title
pCR rate
Description
The pCR rate is defined as the rate of patients achieving pCR.
Time Frame
Postoperative, 2 years
Secondary Outcome Measure Information:
Title
R0 resection rate
Description
The R0 resection rate is defined as the rate of R0 resection.
Time Frame
Postoperative, 2 years
Title
Three-year disease-free survival
Description
The DFS is defined as the period from the time of surgery to recurrence or death.
Time Frame
From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 70 months
Title
Five-year overall survival
Description
The OS is defined as the period from the time of surgery to death or last follow-up.
Time Frame
From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 90 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-bedridden, aged 18 to 70 years old; Eastern Cooperative Oncology Group (ECOG) score is 0 to 1; Histologically confirmed gastric adenocarcinoma; Stage III (American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) gastric cancer confirmed by enhanced computer tomography (enhanced CT) and laparoscopic exploration (endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) if necessary); The research center and the surgeon have the ability to complete standard D2 radical gastrectomy, and the gastrectomy can be tolerated by the patient; Laboratory test criteria: peripheral blood hemoglobin (Hb) ≥ 90 g/L, neutrophil absolute count ≥ 3×109 /L, platelet count (PLT) ≥ 100×109 /L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN, serum creatinine (SCr) ≤ 1.5×ULN, and serum albumin (ALB) ≥ 30 g/L; Patients with heart disease, the echocardiogram showed that the left ventricular ejection fraction ≥ 50%, the electrocardiogram (ECG) is basically normal within 4 weeks before operation and without no obvious symptoms are acceptable; There is no serious underlying disease that could lead to an expected life expectancy < 5 years; Willing to sign the inform consent for participation and publication of results. Exclusion Criteria: Pregnant or lactating women; Positive pregnancy test for women in childbearing age. Menopausal women without menstruation for at least 12 months can be regarded as women with no possibility of getting pregnant; Refuse to birth control during the study; Received any chemotherapy, radiotherapy or immunotherapy before; History of other malignant diseases in the last five years (except for cervical carcinoma in situ); History of uncontrolled central nervous system diseases, which could influence the compliance; History of severe liver diseases, renal diseases or respiratory diseases; Uncontrolled diabetes and hypertension; Clinically severe heart disease, such as congestive heart failure, symptomatic coronary heart disease, uncontrolled arrhythmia, or a history of myocardial infarction in the last six months; History of dysphagia, complete or partial gastrointestinal obstruction, active gastrointestinal bleeding and gastrointestinal perforation; On steroid treatment after organ transplant; With uncontrolled severe infections; Known dihydropyrimidine dehydrogenase deficiency (DPD); Anaphylaxis to any research drug ingredient; Known peripheral neuropathy (> NCI-CTC AE 1). Patients with only disappearance of deep tendon reflex need not to be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinxin Wang, MD
Phone
+8613811858199
Email
301wxx@sina.com
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinxin Wang, Dr.
Phone
+8613811858199
Email
301wxx@sina.com

12. IPD Sharing Statement

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Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer

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