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

Phase Ⅱ/Ⅲ Study of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma

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 Overview

• Status: Unknown
• Conditions: Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Radiation: Preoperative concurrent chemoradiotherapy; Procedure: Radical D2 total gastrectomy; Drug: Adjuvant chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Haidian District, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Shuangxi Li, M.D.; Email: lishuangxi@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Radiation: Preoperative 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.; Other Names: Eloxatin®; CCRT; S-1®; Procedure: Radical 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.; Drug: Adjuvant 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.; Other Names: Eloxatin®; S-1®
Active Comparator: CT group; The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.	Procedure: Radical 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.; Drug: Adjuvant 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.; Other Names: Eloxatin®; S-1®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Peking University People's Hospital; Beijing Friendship Hospital; Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Gastroesophageal junction adenocarcinoma; Neoadjuvant chemoradiotherapy; Preoperative concurrent chemoradiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Esophageal Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: CRADLE