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Trial Title:
Study on Neoadjuvant Chemotherapy for Advanced Gastric Cancer
NCT ID:
NCT02163291
Condition:
Advanced Gastric Carcinoma
Conditions: Official terms:
Stomach Neoplasms
Paclitaxel
Conditions: Keywords:
advanced gastric cancer
neoadjuvant chemotherapy
safety
feasibility
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
paclitaxel liposome
Description:
S-1 40 mg/m2 bid d1-14 po and paclitaxel liposome 175mg/m2 d1 intravenously infusion for
3 hours, every 3 weeks. After 2 cycles' treatment, if clinical response is complete
response（CR）,partial regression（PR） or stable disease（SD）, another 2 cycles is
administered and operation is performed after the total 4 cycles. If response is
progressive disease（PD）, chemotherapy is stopped and operation is performed.
Arm group label:
paclitaxel liposome
Summary:
Gastric cancer is the second cause of cancer related death and China has the most gastric
cancer patients in the world. Although systemic strategies, including adjuvant
chemotherapy, postoperative chemoradiotherapy, perioperative chemotherapy, have evolved
and showed benefits these years, the prognosis of advanced gastric cancer is still not
satisfactory. Optimal regimens and optimal method administration is still being found.
Neoadjuvant chemotherapy has many advantages, including downstaging the tumor, increasing
R0 rate, early eradicating of micrometastasis. In previous trials, combination of
paclitaxel and s-1 has showed safety and tolerance in recurrent or metastatic gastric
cancer. Using liposome as a carrier, paclitaxel has a better histocompatibility and
cellular affinity, resulting a improved stability and reduced toxicity. In this phase II
trial, we are going to study the safety and feasibility of paclitaxel liposome plus s-1
as neoadjuvant chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed gastric cancer
- Disease at clinical stage of resectable or potentially resectable(T3-4, N0-3, M0) by
CT and endoscopic ultrasonography (EUS)
- Karnofsky performance status(KPS） ≥ 70
- No prior antitumor treatment is allowed, including chemotherapy, radiotherapy,
immune therapy or target therapy
- Life expectancy more than 3 months
- Adequate organ function as defined below:White Blood Cell Count （WBC） ≥ 3.0*10^9/l,
Absolute Neutrophil Count （ANC） ≥ 1.5*10^9/l, Hemoglobin ≥ 100 g/l, Platelets ≥
100*10^9/l, Total Bilirubin （TBIL） ≤ 1.5mg/dl, Aspartate Aminotransferase（AST） and
Alanine Aminotransferase(ALT) ≤ 2.5×ULN, Alkaline pPosphatase( ALP) ≤ 2.5×ULN, Renal
Serum Creatinine < 1.5mg/dl
- Adequate lung and heart function
Exclusion Criteria:
- ≥ grade 2 neuropathy
- History of malignancy
- With uncontrolled central nervous system metastasis
- Concurrent disease or condition that would interfere with the subject's safety
(including current active hepatic, biliary, renal, respiratory disease, acute
infection, severe malnutrition, uncontrolled diabetes hypertension et al)
- Severely inadequate intake of water or diet
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Haidian District, Beijing
Zip:
100142
Country:
China
Contact:
Last name:
Ziyu Li, M.D.
Email:
ligregory369@hotmail.com
Contact backup:
Last name:
Zhaodong Xing, M.D.
Email:
xingzhaodong2011@sina.com
Investigator:
Last name:
Jiafu Ji, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Ziyu Li, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Kan Xue, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Zhaodong Xing, MD
Email:
Sub-Investigator
Start date:
December 2013
Completion date:
December 2014
Lead sponsor:
Agency:
Peking University
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02163291
