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Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
Conditions
Gastroesophageal Junction Adenocarcinoma
Conditions: official terms
Adenocarcinoma - Esophageal Neoplasms
Conditions: Keywords
Preoperative concurrent chemoradiotherapy, Neoadjuvant chemoradiotherapy, Gastroesophageal junction adenocarcinoma
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Preoperative concurrent chemoradiotherapy
Type: Radiation
Name: Radical D2 total gastrectomy
Type: Procedure
Name: Adjuvant chemotherapy
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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≤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
- 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
Location
Beijing Cancer Hospital
Haidian District, Beijing, China
Status: Recruiting
Contact: Shuangxi Li, M.D. - lishuangxi@outlook.com
Start Date
January 2014
Completion Date
May 2020
Sponsors
Peking University
Source
Peking University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page