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Concurrent chemoradiotherapy has been demonstrated a significant improvement in overall survival and disease-free survival according to Intergroup Trial 0116 in patients with gastric cancer after surgical resection. However,there are still many patients experiencing local recurrence or distant metastasis after adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer after resection. The optimal and standard regimen for adjuvant treatment has not been established in locally advanced gastric cancer yet.The investigators designed the trial to investigate the efficacy and safety of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy regimen compared with classical FOLFOX6 regimen as adjuvant chemotherapy and 5-FU/CF as chemoradiotherapy in patients of locally advanced gastric cancer after D2 radical resection.
In Intergroup 0116 trial, 5-FU plus CF regimen was used as adjuvant chemotherapy and concurrent chemoradiotherapy in patients with resected gastric cancer.But 33 percent of those in the chemoradiotherapy group had distant relapses. Docetaxel plus cisplatin regimen as adjuvant chemotherapy for gastric cancer has been proofed Safe and Effective in many clinical trials about gastric cancer. The purpose of this study is to evaluate efficacy and safety of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy regimen compared with classical FOLFOX6 regimen as adjuvant chemotherapy and 5-FU/CF as chemoradiotherapy in patients of locally advanced gastric cancer after D2 radical surgery. The investigators hope the new interventions can reduce the rate of distant metastasis and have more clinical benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | chemotherapy regimen:Oxaliplatin 85mg/m2 IV d1,Leucovorin 400mg/m2 IV d1,5-FU 400mg/m2 IV bolus d1 ,then 2400mg/m2 over 46h continuous infusion Q2W for 3 cycles → 5-FU 400 mg/m2 IV and Leucovorin 20 mg/m2 IV on the first four and the last three days of radiotherapy + RT 45Gy (5weeks)→ Rest for 4 weeks →Oxaliplatin 85mg/m2 IV d1,Leucovorin 400mg/m2 IV d1,5-FU 400mg/m2 IV bolus d1 ,then 2400mg/m2 over 46h continuous infusion Q2W for 3 cycles. Radiation: concurrent chemoradiotherapy with 5-FU/CF.Radiotherapy consisted of 45Gy of radiation at 1.8Gy per day, five days per week for five weeks. |
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| Arm B | Experimental | chemotherapy regimen:Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W x 2 cycles → Docetaxel 35mg iv D1,Cisplatin 25mg iv D1,QWx4 cycles(but rest in the 4th week during RT) + RT 45Gy (5weeks) for concurrent chemoradiotherapy→ Rest for 4 weeks → Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W x 2 cycles Radiation: concurrent chemoradiotherapy with DC.Radiotherapy consisted of 45Gy of radiation at 1.8Gy per day, five days per week for five weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC | Drug | Docetaxel plus cisplatin chemotherapy regimen was delivered as chemotherapy and concurrent chemoradiotherapy. chemotherapy regimen: Docetaxel(Qilu Pharma. China) 75mg iv D1, Cisplatin(Qilu Pharma. China) 75mg iv D1 ,Q3W for 2 cycles, then Docetaxel 35mg iv D1, Cisplatin 25mg iv D1,QWx4 cycles(but rest in the 4th week during RT) + RT 45Gy( 5weeks) for concurrent chemoradiotherapy→ Rest for 4 weeks → Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W for 2 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as 2 or 3 year disease free survival | 2,3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival(OS) | efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as 3-year overall survival | 3 year |
| Local and regional control rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| F X Zhou, PHD | Contact | 86-27-67813155 | happyzhoufx@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Y F Zhou, PHD | President of Zhongnan Hospital of Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430071 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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| concurrent chemoradiotherapy with 5-FU/CF | Drug | FOLFOX6 regiment was delivered as adjuvant chemotherapy and 5-FU/CF as concurrent chemotherapy treatment. Adjuvant chemotherapy: FOLFOX6 regiment : Oxaliplatin(Hengrui Medicine Co., Ltd,China) 85mg/m2 IV d1, Leucovorin (Hengrui Medicine Co., Ltd,China)400mg/m2 IV d1, 5-FU(Hengrui Medicine Co., Ltd,China) 400mg/m2 IV bolus d1, followed with 2400mg/m2 over 46h continuous infusion Q2Wx3 cycles of chemotherapy Concurrent chemotherapy : 5-FU 400mg/m2 IV and Leucovorin 20mg/m2 IV were given on the first four and the last three days in the period of radiotherapy. After radiation, patients will have a rest lasting for 4 weeks and then given Folxof6 regiment chemotherapy for 3 cycles. |
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| radiation | Radiation | Therapy plan system was formulated by CT simulation. Radiation was delivered with 15MV photons in both Arm A and Arm B. Radiotherapy consisted of 45Gy of radiation at 1.8Gy/day, five days per week for 5 weeks, to the tumor bed, to the margins of resection, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered. |
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efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as local and regional control rate |
| 2,3 year |
| feasibility (including adverse events ) | feasibility of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as toxicities and rate of patients complete concurrent chemoradiation according to protocol. | 3year |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D055585 |
| Physical Phenomena |