Phase Ⅱ/Ⅲ Study of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Preoperative concurrent chemoradiotherapy
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Sponsor
- Peking University
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- The patient's survival time and recurrence time
- Last Updated
- 10 years ago
Overview
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.
Investigators
Jiafu Ji
President of Beijing Cancer Hospital,Director of Key Laboratory of Carcinogenesis and Translational Research(Gastric Cancer Laboratory)
Peking University
Eligibility Criteria
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≤
- •Informed consent obtained.
Exclusion Criteria
- •Combined with other malignant tumors.
- •Eastern Cooperative Oncology Group (ECOG) performance status\>
- •Combined with severe organ dysfunction.
- •Pregnancy
Arms & Interventions
CCRT group
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.
Intervention: Preoperative concurrent chemoradiotherapy
CCRT group
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.
Intervention: Radical D2 total gastrectomy
CCRT group
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.
Intervention: Adjuvant chemotherapy
CT group
The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.
Intervention: Radical D2 total gastrectomy
CT group
The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.
Intervention: Adjuvant chemotherapy
Outcomes
Primary Outcomes
The patient's survival time and recurrence time
Time Frame: Up to 3 years
3-year overall survival 1-year and 3-year recurrence free survival
Secondary Outcomes
- The number of patients with complications(Within 30 days after the day of operation)