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Trial of Xeloda and Oxaliplatin (XELOX) as Neo-adjuvant Chemotherapy Followed by Surgery in Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis

Primary Purpose

Advanced Gastric Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Capecitabine

Oxaliplatin

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring neo-adjuvant chemotherapy, advanced gastric cancer patients, para-aortic lymph node metastasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Gastric or gastroesophageal adenocarcinoma proven histologically .
Has para-aortic lymph node metastasis(PAN was defined as nodes in the region between the upper margin of the celiac artery and the upper border of the inferior mesenteric artery (stations no. 16a2/16b1))
Eastern Cooperative Oncology Group performance status of 0 to 1.
Life expectancy ≥12 weeks.
Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN , ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L。 Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
Female subjects should not be pregnant or breast-feeding.
No serious concomitant disease that will threaten the survival of patients to less than 5 years.

Exclusion Criteria:

Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
History of another malignancy in the last 5 years with the exception of the following:
Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy. Prior treatment for locally advanced or metastatic gastric cancer.
Any other metastatic disease will render patient ineligible according to AJCC staging manual(such as liver，lung，etc）.
Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
Poorly controlled diabetes mellitus with fasting blood sugar > 18 mm. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
Unstable, persistent cardiac disease despite medicinal treatment, myocardial infarction within 6 months before the start of the trial
Previous surgery on primary tumour; Prior palliative surgery (open and closure, passage operation)
Any other type of tumour (e.g. leiomyosarcoma, lymphoma) or a secondary malignancy, excepting basal cell skin carcinoma or basal cell carcinoma in situ of the cervix which have already been successfully treated -

Sites / Locations

Zhongshan Hospital Affiliated to Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XELOX

Arm Description

XELOX: Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ，orally taken 30 minutes after meal, bid ， d 1~14 every 3 weeks(treatment for 2 weeks and rest 1 week) Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks

Outcomes

Primary Outcome Measures

The primary study end point was the response rate of preoperative XELOX followed by surgery in gastric cancer patients with PAN involvement

evaluation will be based on tumor assessment with follow-up, including chest and upper-abdominal During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after).After surgery, CT scan will be planned every 3 months, brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur.

Secondary Outcome Measures

progression-free survival (PFS)

be based on tumor assessment with follow-up, including chest and upper-abdominal During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after).After surgery, CT scan will be planned every 3 months, brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur.

overall survival

out-patient clinic and telephone visit will be done every 3 months for the first two years, and every 6 months after two years

Grade 3 or 4 Adverse Events as a Measure of Safety

Adverse Events will measure in the whole study according to CTC-AE 4.0

Full Information

NCT ID

NCT02071043

First Posted

February 18, 2014

Last Updated

February 23, 2014

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02071043

Brief Title

Trial of Xeloda and Oxaliplatin (XELOX) as Neo-adjuvant Chemotherapy Followed by Surgery in Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Gastric cancer with para-aortic lymph node (PAN) involvement is regarded as advanced disease, and only chemotherapy is recommended from the guidelines. In unresectable cases, neoadjuvant chemotherapy could prolong survival if conversion to resectability could be achieved.

6. Conditions and Keywords

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

Advanced Gastric Cancer

Keywords

neo-adjuvant chemotherapy, advanced gastric cancer patients, para-aortic lymph node metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

XELOX

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

Capecitabine 1000 mg/m2 ，orally taken 30 minutes after meal, bid ， d 1~14 every 3

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks

Primary Outcome Measure Information:

Title

The primary study end point was the response rate of preoperative XELOX followed by surgery in gastric cancer patients with PAN involvement

Description

Time Frame

8 Months after the last subject participate in

Secondary Outcome Measure Information:

Title

progression-free survival (PFS)

Description

Time Frame

40 Months after the last subject participate in

Title

overall survival

Description

out-patient clinic and telephone visit will be done every 3 months for the first two years, and every 6 months after two years

Time Frame

3 years after the last subject participate in

Title

Grade 3 or 4 Adverse Events as a Measure of Safety

Description

Adverse Events will measure in the whole study according to CTC-AE 4.0

Time Frame

1 year after the last subject finish the treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Gastric or gastroesophageal adenocarcinoma proven histologically . Has para-aortic lymph node metastasis(PAN was defined as nodes in the region between the upper margin of the celiac artery and the upper border of the inferior mesenteric artery (stations no. 16a2/16b1)) Eastern Cooperative Oncology Group performance status of 0 to 1. Life expectancy ≥12 weeks. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level). Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN , ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L。 Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min. Female subjects should not be pregnant or breast-feeding. No serious concomitant disease that will threaten the survival of patients to less than 5 years. Exclusion Criteria: Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator. History of another malignancy in the last 5 years with the exception of the following: Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy. Prior treatment for locally advanced or metastatic gastric cancer. Any other metastatic disease will render patient ineligible according to AJCC staging manual(such as liver，lung，etc）. Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy. Poorly controlled diabetes mellitus with fasting blood sugar > 18 mm. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. Unstable, persistent cardiac disease despite medicinal treatment, myocardial infarction within 6 months before the start of the trial Previous surgery on primary tumour; Prior palliative surgery (open and closure, passage operation) Any other type of tumour (e.g. leiomyosarcoma, lymphoma) or a secondary malignancy, excepting basal cell skin carcinoma or basal cell carcinoma in situ of the cervix which have already been successfully treated -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tianshu Liu, Doctor

Organizational Affiliation

Medicine-Oncology Derpartment of Zhongshan hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital Affiliated to Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Learn more about this trial

Trial of Xeloda and Oxaliplatin (XELOX) as Neo-adjuvant Chemotherapy Followed by Surgery in Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis

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