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Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer (repeat)

Primary Purpose

Gastric Cancer

Status

Terminated

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Capecitabine

Oxaliplatin

D2 resection

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring xelox, advanced gastric cancer

Eligibility Criteria

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

Inclusion Criteria:

Karnofsky performance status of ≥60 %.
Histologically confirmed gastric adenocarcinoma, staged pathologically or clinically, stage cT2-4N+M0, and cT4N0M0.
Patients had to have adequate renal function (serum creatinine ≤1 times the upper limit of normal [ULN]), hepatic function (total bilirubin ≤1·5 times the ULN, aspartate or alanine aminotransferase ≤2·5 times the ULN, alkaline phosphatase ≤2·5 times the ULN, Serum albumin ≥30g/L), and haematological function (absolute neutrophil count ≥1·5×10⁹/L and platelet count ≥100×10⁹/L)

Exclusion Criteria:

Pregnant or lactating women.
According to the AJCC TMN 7.0, Any evidence of metastatic (TxNxM1) patients(including presence of tumor cells in the ascites).
Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
Has uncontrolled epilepsy, central nervous system diseases or mental disorders of history.
Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
Known peripheral neuropathy ≥ CTCAEv3 grade 1 (Common Terminology for Adverse Events). Absence of deep tendon reflexes as the sole neurologic abnormality does not render the patient ineligible.
Organ allografts requiring immunosuppressive therapy.
Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
Moderate or severe renal impairment [creatinine clearance equal to or below 50 ml/min (calculated according to Cockroft and Gault)], or serum creatinine > 1.5 x upper limit of normal (ULN).
Any of the following laboratory values:
- Absolute neutrophil count (ANC) < 1.5 x 109/L
- Platelet count < 100 x 109/L
- Total bilirubin > 1.5 x ULN
- ALAT, ASAT > 2.5 x ULN
- Alkaline phosphatase > 2.5 x ULN.
Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency.
Hypersensitivity to platinum compounds or any of the components of the study medications.
Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

Harbin Medical University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

XELOX adjuvant group

XELOX neoadjuvant

Arm Description

D2 resection XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 6 cycles

XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy before operation. D2 resection After operation: CR/PR: XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy after operation. SD/PD:,ST(Drug: S-1，40-75mg twice daily. d1-14 q3w Drug: Paclitaxel IV infusion 135mg/m2 d1; q3w) 3 cycles chemotherapy after operation.

Outcomes

Primary Outcome Measures

3-year DFS

Secondary Outcome Measures

adverse events

response rate

R0 resection rate

overall survival

Full Information

NCT ID

NCT01665274

First Posted

August 5, 2012

Last Updated

September 29, 2022

Sponsor

Harbin Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01665274

Brief Title

Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer

Acronym

repeat

Official Title

A Randomized Single Center Controlled Study of Perioperative Chemotherapy of Oxaliplatin Combined With Capecitabine (XELOX) Versus XELOX as Post-operative Chemotherapy in Advanced Gastric Adenocarcinoma With D2 Dissection

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Terminated

Why Stopped

we are working on a larger similar multicenter cinical trials as a participant.so in order to avoid conflicts of interest, we have to suspended this project.

Study Start Date

September 2013 (undefined)

Primary Completion Date

August 2020 (Actual)

Study Completion Date

September 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harbin Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to demonstrate that capecitabine/oxaliplatin as perioperative chemotherapy is superior or not to operation directly for locally advanced gastric cancer in terms of 3 year disease-free survival (DFS) rate.

Detailed Description

The patients of gastric cancer have been divided into two parts in random.The test group receive perioperative chemotherapy (XELOX) six cycles and the control group administrate the same program after operation. The two groups have the same staging and eligibility criteria.The 3 year disease-free survival (DFS) rate and 5 year overall survival (OS) rate maybe the last evaluation standard.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

xelox, advanced gastric cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

XELOX adjuvant group

Arm Type

Active Comparator

Arm Description

D2 resection XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 6 cycles

Arm Title

XELOX neoadjuvant

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

xeloda

Intervention Description

Capecitabine 1,000 mg/m² twice daily, d1-14, q3w

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

eloxatin

Intervention Description

Oxaliplatin IV infusion, 130mg/m² d1, q3w

Intervention Type

Procedure

Intervention Name(s)

D2 resection

Intervention Description

D2 resection

Primary Outcome Measure Information:

Title

3-year DFS

Time Frame

3 years after surgery

Secondary Outcome Measure Information:

Title

adverse events

Time Frame

From date of randomization until the end of the study, assessed up to 5 years

Title

response rate

Time Frame

evaluate after the end of neoadjuvant chemotherapy ie within 1 weeks after the neoadjuvant therapy

Title

R0 resection rate

Time Frame

after the pathological examination of resected speciments ie within 1 month after the operation

Title

overall survival

Time Frame

5 years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Karnofsky performance status of ≥60 %. Histologically confirmed gastric adenocarcinoma, staged pathologically or clinically, stage cT2-4N+M0, and cT4N0M0. Patients had to have adequate renal function (serum creatinine ≤1 times the upper limit of normal [ULN]), hepatic function (total bilirubin ≤1·5 times the ULN, aspartate or alanine aminotransferase ≤2·5 times the ULN, alkaline phosphatase ≤2·5 times the ULN, Serum albumin ≥30g/L), and haematological function (absolute neutrophil count ≥1·5×10⁹/L and platelet count ≥100×10⁹/L) Exclusion Criteria: Pregnant or lactating women. According to the AJCC TMN 7.0, Any evidence of metastatic (TxNxM1) patients(including presence of tumor cells in the ascites). Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer. Has uncontrolled epilepsy, central nervous system diseases or mental disorders of history. Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months. Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication. Known peripheral neuropathy ≥ CTCAEv3 grade 1 (Common Terminology for Adverse Events). Absence of deep tendon reflexes as the sole neurologic abnormality does not render the patient ineligible. Organ allografts requiring immunosuppressive therapy. Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease. Moderate or severe renal impairment [creatinine clearance equal to or below 50 ml/min (calculated according to Cockroft and Gault)], or serum creatinine > 1.5 x upper limit of normal (ULN). Any of the following laboratory values: Absolute neutrophil count (ANC) < 1.5 x 109/L Platelet count < 100 x 109/L Total bilirubin > 1.5 x ULN ALAT, ASAT > 2.5 x ULN Alkaline phosphatase > 2.5 x ULN. Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency. Hypersensitivity to platinum compounds or any of the components of the study medications. Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yingwei Xue, Phd, MD

Organizational Affiliation

Harbin Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Harbin Medical University Cancer Hospital

City

Harbin

State/Province

Heilongjiang

Country

China

12. IPD Sharing Statement

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Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer

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