Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of gastroesophageal junction and upper gastric cancers in the decade.According to some researches,CRT had shown its good curative effects in local control and prolonged overall survival.However,the optimization scheme for CRT and its influence to surgery remains controversial.Meanwhile,there were many design flaws in the past few research,such as the lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety of CRT.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCRT group | Experimental | The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles. |
|
| CT group | Active Comparator | The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative concurrent chemoradiotherapy | Radiation | The patients will receive radiotherapy in the total amount of 50Gy(25 fractions) preoperatively,concurrently combined with chemotherapy,which consist of oxaliplatin 40mg/m2 administrated on days 1,8,15,22,29 and S-1® 30mg/m2 twice per day on days 1 to 5 per week. |
| Measure | Description | Time Frame |
|---|---|---|
| The patient's survival time and recurrence time | 3-year overall survival 1-year and 3-year recurrence free survival | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients with complications | the morbidity and mortality rates within 30 days after the day of operation | Within 30 days after the day of operation |
| Measure | Description | Time Frame |
|---|---|---|
| The pathologic profiles and the pathologic response rates | the pathologic profiles and the pathologic response rates | Within 30 days after the day of operation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiafu Ji, M.D. | Contact | jiafuj@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiafu Ji, M.D. | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Haidian District | Beijing Municipality | 100142 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Radical D2 total gastrectomy | Procedure | Within 5-6 weeks after the completion of neoadjuvant therapy,the patients in CCRT group will receive the radical total gastrectomy with D2 lymphadenectomy,and patients in the CT group will receive the surgery right after randomization. |
|
| Adjuvant chemotherapy | Drug | Within 2 months after surgery,the patients will receive chemotherapy for 6 to 8 cycles ,consist of oxaliplatin 130mg/m2 administrated on day1 and S-1® 40-60mg twice per day on days 1 to 14 per 3 weeks.The S-1® dosage depends on the patient BSA(BSA<1.25m2 40mg,1.25 m2≤BSA≤1.5 m2 50mg ,BSA>1.5 m2 60mg). Patients in the CCRT group will receive 6 cycles of chemotherapy and patients in the CT group will receive 8 cycles of chemotherapy. |
|
|
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| C079198 | S 1 (combination) |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided