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Study on Neoadjuvant Chemotherapy for Advanced Gastric Cancer

Primary Purpose

Advanced Gastric Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

paclitaxel liposome

About this trial

This is an interventional treatment trial for Advanced Gastric Carcinoma focused on measuring advanced gastric cancer, neoadjuvant chemotherapy, safety, feasibility

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Peking University Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

paclitaxel liposome

Arm Description

S-1 plus paclitaxel liposome

Outcomes

Primary Outcome Measures

Pathological complete response rate

Pathology is usually reported 1 week after operation.The result of Pathological complete response rate will be accessed after all of the 30 participants operated.

Secondary Outcome Measures

Object Response Rate

Object Response Rate(ORR) is defined as the percentage of CR and PR among all of the participants under best overall outcome evaluation .Pathology is usually reported 1 week after operation.The result of Object Response Rate will be accessed after all of the 30 participants operated.

Disease Control Rate

Disease Control Rate(DC R) is defined as the percentage of CR+PR+SD among all of the participants under best overall outcome evaluation .Pathology is usually reported 1 week after operation.The result of Disease Control Rate will be accessed after all of the 30 participants operated.

Number of Participants with Adverse Eventss a Measure of Safety and Tolerability

Participants will be followed during all the s a Measure of Safety and Tolerability4 circles of chemotherapy ,an expected average of 12 weeks.Number of participants with Adverse Events will calculated as a Measure of Safety and Tolerability.

R0 rate, surgical morbidity and mortality

The results of R0 rate, surgical morbidity and mortality will be accessed after operation ,participants will be followed for the duration of hospital stay, an expected average of 2 weeks .

Full Information

NCT ID

NCT02163291

First Posted

June 7, 2014

Last Updated

June 11, 2014

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT02163291

Brief Title

Study on Neoadjuvant Chemotherapy for Advanced Gastric Cancer

Official Title

Phase II Study of Paclitaxel Liposome Plus S-1 as Neoadjuvant Chemotherapy for Advanced Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

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

Advanced Gastric Carcinoma

Keywords

advanced gastric cancer, neoadjuvant chemotherapy, safety, feasibility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

paclitaxel liposome

Arm Type

Experimental

Arm Description

S-1 plus paclitaxel liposome

Intervention Type

Drug

Intervention Name(s)

paclitaxel liposome

Intervention 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.

Primary Outcome Measure Information:

Title

Pathological complete response rate

Description

Pathology is usually reported 1 week after operation.The result of Pathological complete response rate will be accessed after all of the 30 participants operated.

Time Frame

up to 24 weeks

Secondary Outcome Measure Information:

Title

Object Response Rate

Description

Time Frame

up to 24 weeks

Title

Disease Control Rate

Description

Time Frame

up to 24 weeks

Title

Number of Participants with Adverse Eventss a Measure of Safety and Tolerability

Description

Time Frame

up to 12 weeks

Title

R0 rate, surgical morbidity and mortality

Description

The results of R0 rate, surgical morbidity and mortality will be accessed after operation ,participants will be followed for the duration of hospital stay, an expected average of 2 weeks .

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiafu Ji, M.D.

jiafuj@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiafu Ji, M.D.

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Cancer Hospital

City

Haidian District, Beijing

ZIP/Postal Code

100142

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ziyu Li, M.D.

ligregory369@hotmail.com

First Name & Middle Initial & Last Name & Degree

Zhaodong Xing, M.D.

xingzhaodong2011@sina.com

First Name & Middle Initial & Last Name & Degree

Jiafu Ji, M.D.

First Name & Middle Initial & Last Name & Degree

Ziyu Li, M.D.

First Name & Middle Initial & Last Name & Degree

Kan Xue, M.D.

First Name & Middle Initial & Last Name & Degree

Zhaodong Xing, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20207133

Citation

Wang X, Zhou J, Wang Y, Zhu Z, Lu Y, Wei Y, Chen L. A phase I clinical and pharmacokinetic study of paclitaxel liposome infused in non-small cell lung cancer patients with malignant pleural effusions. Eur J Cancer. 2010 May;46(8):1474-80. doi: 10.1016/j.ejca.2010.02.002. Epub 2010 Mar 6.

Results Reference

background

PubMed Identifier

19019625

Citation

Zhang Q, Huang XE, Gao LL. A clinical study on the premedication of paclitaxel liposome in the treatment of solid tumors. Biomed Pharmacother. 2009 Sep;63(8):603-7. doi: 10.1016/j.biopha.2008.10.001. Epub 2008 Oct 31.

Results Reference

background

PubMed Identifier

24453274

Citation

Chen L, Chen Q, Zhuang Z, Zhang Y, Tao J, Shen L, Shen X, Chen Z, Wang J, Zhu M, Wang H. Effect of the weekly administration of liposome-Paclitaxel combined with s-1 on advanced gastric cancer. Jpn J Clin Oncol. 2014 Mar;44(3):208-13. doi: 10.1093/jjco/hyt212. Epub 2014 Jan 22.

Results Reference

background

PubMed Identifier

23810466

Citation

Huang D, Ba Y, Xiong J, Xu N, Yan Z, Zhuang Z, Yu Z, Wan H, Zhang Y, Deng T, Zheng R, Guo Z, Hu C, Wang M, Yu Z, Yao Y, Meng J. A multicentre randomised trial comparing weekly paclitaxel + S-1 with weekly paclitaxel + 5-fluorouracil for patients with advanced gastric cancer. Eur J Cancer. 2013 Sep;49(14):2995-3002. doi: 10.1016/j.ejca.2013.05.021. Epub 2013 Jun 27.

Results Reference

background

PubMed Identifier

18813927

Citation

Lee JJ, Kim SY, Chung HC, Lee KH, Song HS, Kang WK, Hong YS, Choi IS, Lee YY, Woo IS, Choi JH. A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer. Cancer Chemother Pharmacol. 2009 May;63(6):1083-90. doi: 10.1007/s00280-008-0818-3. Epub 2008 Sep 24.

Results Reference

background

PubMed Identifier

18317763

Citation

Nakajo A, Hokita S, Ishigami S, Miyazono F, Etoh T, Hamanoue M, Maenohara S, Iwashita T, Komatsu H, Satoh K, Aridome K, Morita S, Natsugoe S, Takiuchi H, Nakano S, Maehara Y, Sakamoto J, Aikou T; Kyushu Taxol TS-1 Study Group. A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer. Cancer Chemother Pharmacol. 2008 Nov;62(6):1103-9. doi: 10.1007/s00280-008-0693-y. Epub 2008 Mar 4.

Results Reference

background

PubMed Identifier

22617130

Citation

Mochiki E, Ogata K, Ohno T, Toyomasu Y, Haga N, Fukai Y, Aihara R, Ando H, Uchida N, Asao T, Kuwano H; North Kanto Gastric Cancer Study Group. Phase II multi-institutional prospective randomised trial comparing S-1+paclitaxel with S-1+cisplatin in patients with unresectable and/or recurrent advanced gastric cancer. Br J Cancer. 2012 Jun 26;107(1):31-6. doi: 10.1038/bjc.2012.222. Epub 2012 May 22.

Results Reference

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Study on Neoadjuvant Chemotherapy for Advanced Gastric Cancer

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