Treatment of Chinese patients with metastatic gastric cancer where resection is not possible
| ISRCTN | ISRCTN85705844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85705844 |
| Protocol serial number | N/A |
| Sponsor | Zhejiang University (China) |
| Funders | National Natural Science Foundation of China (Grant No. 81001212) (China), Foundation of Zhejiang Provincial Educational Committee (Grant No. Y201019175) (China), Zhejiang Provincial Health Bureau Foundation (Grant No. 2010KYB036) (China) |
- Submission date
- 19/03/2011
- Registration date
- 15/04/2011
- Last edited
- 09/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Weijia Fang
Scientific
Scientific
79 Qingchun Road
Hangzhou
310003
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label multi-centre phase II study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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) |
| Study acronym | SPA/SOX |
| Study objectives | 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(s) | The First Affiliated Hospital Ethical Review Board, School of Medicine, Zhejiang University, 02/05/2010, Ethics Review No. 21 (2010) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | 1. S-1 2. Paclitaxel 3. Oxaliplatin |
| Primary outcome measure(s) |
Progression-free survival |
| Key secondary outcome measure(s) |
1. Overall survival |
| Completion date | 31/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- China
Study participating centre
79 Qingchun Road
Hangzhou
310003
China
310003
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
