Gastroesophageal Junction Adenocarcinoma
Conditions
Keywords
Preoperative concurrent chemoradiotherapy, Neoadjuvant chemoradiotherapy, Gastroesophageal junction adenocarcinoma
Brief summary
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.
Interventions
RADIATIONPreoperative concurrent chemoradiotherapy
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.
PROCEDURERadical D2 total gastrectomy
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.
DRUGAdjuvant chemotherapy
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.
Sponsors
Chinese PLA General Hospital
Peking University People's Hospital
Beijing Friendship Hospital
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven adenocarcinoma of the gastroesophageal junction. * Clinical stage diagnosed by endoscopic ultrasound(EUS) or computed tomography(CT) as T3-4NxM0 tumors,according to American Joint Committee on Cancer (AJCC) 7th edition. * Eastern Cooperative Oncology Group (ECOG) performance status≤2. * Informed consent obtained.
Exclusion criteria
* Combined with other malignant tumors. * Eastern Cooperative Oncology Group (ECOG) performance status\>2. * Combined with severe organ dysfunction. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The patient's survival time and recurrence time | Up to 3 years | 3-year overall survival 1-year and 3-year recurrence free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients with complications | Within 30 days after the day of operation | the morbidity and mortality rates within 30 days after the day of operation |
Other
| Measure | Time frame | Description |
|---|---|---|
| The pathologic profiles and the pathologic response rates | Within 30 days after the day of operation | the pathologic profiles and the pathologic response rates |
Countries
China
Contacts
Primary ContactJiafu Ji, M.D.
Outcome results
None listed