Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma

Phase 3UnknownNCT02193594

Peking University214 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

214

Conditions

Gastroesophageal Junction Adenocarcinoma

Interventions

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.

Radical D2 total gastrectomyPROCEDURE

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 chemotherapyDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The patient's survival time and recurrence time

3-year overall survival 1-year and 3-year recurrence free survival

Time frame: Up to 3 years

Secondary Outcomes

The number of patients with complications

the morbidity and mortality rates within 30 days after the day of operation

Time frame: Within 30 days after the day of operation