Condition category
Cancer
Date applied
19/03/2011
Date assigned
15/04/2011
Last edited
09/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Weijia Fang

ORCID ID

Contact details

79 Qingchun Road
Hangzhou
310003
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Treatment of Chinese patients with metastatic gastric cancer where resection is not possible, with a biweekly combination of S-1 and Paclitaxel (SPA) or a combination of S-1 and Oxaliplatin (SOX)

Acronym

SPA/SOX

Study hypothesis

The use of S-1 plus Paclitaxel or S-1 plus Oxaliplatin as first-line or second-line treatment will be beneficial in patients with metastatic gastric cancer where resection is not possible

Ethics approval

The First Affiliated Hospital Ethical Review Board, School of Medicine, Zhejiang University, 02/05/2010, Ethics Review No. 21 (2010)

Study design

Open-label multi-centre phase II study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Metastatic gastric cancer or where resection is not possible

Intervention

1. Patients were randomized (1:1) according to the following sequences:
1.1. Arm A: S-1 was administered orally (80 mg/m2/day) after meal for 7 days followed by a 7-day rest every 2 weeks with Paclitaxel 120 mg/m2
1.2. Arm B: S-1 was administered orally (80 mg/m2/day) after meal for 7 days followed by a 7-day rest every 2 weeks withoxaliplatin 85 mg/m2 as a 2-hour infusion on day 1
2. Toxicity evaluations were based on the National Cancer Institute Common Toxicity Criteria for Adverse Events v3.0
3. Radiological evaluations were conducted at base line and after every three courses
4. At progression, Paclitaxel was replaced by oxaliplatin (Arm A), or oxaliplatin by Paclitaxel (Arm B)

Intervention type

Drug

Phase

Phase II

Drug names

1. S-1
2. Paclitaxel
3. Oxaliplatin

Primary outcome measures

Progression-free survival

Secondary outcome measures

1. Overall survival
2. Response rate
3. Safety

Overall trial start date

01/03/2010

Overall trial end date

31/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with unresectable or metastatic gastric cancer were eligible for this study
2. Patients were required to have histological or cytological proof of locally advanced or metastatic transitional cell carcinoma of the bladder, ureter or renal pelvis
3. Prior cytotoxic treatment in the adjuvant setting was permitted if the treatment had been completed at least six months prior to enrollment in the study
4.Prior radiotherapy was permitted but must have been completed at least six weeks prior to enrollment
5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
6. A life expectancy at least 4 months
7. Age between 18 and 75 years
8.Adequate bone marrow: absolute neutrophil count more than or equal to 1.5x10E9/L platelet count more than or equal to 100x10E9/L,and hemoglobin more than or equal to 90g/L
9. Adequate hepatic functions: aspartate aminotransferase (AST) and (alanine aminotransferase) ALT less than or equal to 3.0 times the upper normal limit (UNL) and serum bilirubin less than or equal to 1.5
10. Adequate renal functions: serum creatinine less than or equal to 133umol/L
11. Adequate normal cardiac function

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 (50 in each arm)

Participant exclusion criteria

1. Second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma
2. Central nervous system (CNS) involvement
3. Prior radiotherapy in parameter lesions
4. Concurrent uncontrolled medical illness

Recruitment start date

01/03/2010

Recruitment end date

31/05/2012

Locations

Countries of recruitment

China

Trial participating centre

79 Qingchun Road
Hangzhou
310003
China

Sponsor information

Organisation

Zhejiang University (China)

Sponsor details

338 Yuhangtang Road
Hangzhou
310058
China
-
Chyx@zju.edu.cn

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Natural Science Foundation of China (Grant No. 81001212) (China)

Alternative name(s)

National Science Foundation of China, Natural Science Foundation of China, NSFC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

China

Funder name

Foundation of Zhejiang Provincial Educational Committee (Grant No. Y201019175) (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Zhejiang Provincial Health Bureau Foundation (Grant No. 2010KYB036) (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26013324

Publication citations

Additional files

Editorial Notes