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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02193594
Recruitment Status : Recruiting
First Posted : July 17, 2014
Last Update Posted : June 8, 2015
Sponsor:
Collaborators:
Chinese PLA General Hospital
Peking University People's Hospital
Beijing Friendship Hospital
Information provided by (Responsible Party):
Jiafu Ji, Peking University

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Junction Adenocarcinoma Radiation: Preoperative concurrent chemoradiotherapy Procedure: Radical D2 total gastrectomy Drug: Adjuvant chemotherapy Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ⅱ/Ⅲ Study of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
Study Start Date : January 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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:
  • CCRT
  • Eloxatin®
  • 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®




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The number of patients with complications [ Time Frame: Within 30 days after the day of operation ]
    the morbidity and mortality rates within 30 days after the day of operation


Other Outcome Measures:
  1. The pathologic profiles and the pathologic response rates [ Time Frame: Within 30 days after the day of operation ]
    the pathologic profiles and the pathologic response rates



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193594


Contacts
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Contact: Jiafu Ji, M.D. jiafuj@hotmail.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Haidian District, Beijing, China, 100142
Contact: Shuangxi Li, M.D.       lishuangxi@outlook.com   
Principal Investigator: Jiafu Ji, M.D.         
Sub-Investigator: Ziyu Li, M.D.         
Sub-Investigator: Shuangxi Li, M.D.         
Sponsors and Collaborators
Peking University
Chinese PLA General Hospital
Peking University People's Hospital
Beijing Friendship Hospital
Investigators
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Principal Investigator: Jiafu Ji, M.D. Beijing Cancer Hospital

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Responsible Party: Jiafu Ji, President of Beijing Cancer Hospital,Director of Key Laboratory of Carcinogenesis and Translational Research(Gastric Cancer Laboratory), Peking University
ClinicalTrials.gov Identifier: NCT02193594    
Other Study ID Numbers: CRADLE
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by Jiafu Ji, Peking University:
Preoperative concurrent chemoradiotherapy
Neoadjuvant chemoradiotherapy
Gastroesophageal junction adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Oxaliplatin
Antineoplastic Agents