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Trial Title:
Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
NCT ID:
NCT02193594
Condition:
Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Oxaliplatin
Conditions: Keywords:
Preoperative concurrent chemoradiotherapy
Neoadjuvant chemoradiotherapy
Gastroesophageal junction adenocarcinoma
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Preoperative concurrent chemoradiotherapy
Description:
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.
Arm group label:
CCRT group
Other name:
CCRT
Other name:
Eloxatin®
Other name:
S-1®
Intervention type:
Procedure
Intervention name:
Radical D2 total gastrectomy
Description:
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.
Arm group label:
CCRT group
Arm group label:
CT group
Intervention type:
Drug
Intervention name:
Adjuvant chemotherapy
Description:
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.
Arm group label:
CCRT group
Arm group label:
CT group
Other name:
Eloxatin®
Other name:
S-1®
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Haidian District
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuangxi Li, M.D.
Email:
lishuangxi@outlook.com
Investigator:
Last name:
Jiafu Ji, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Ziyu Li, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Shuangxi Li, M.D.
Email:
Sub-Investigator
Start date:
January 2014
Completion date:
May 2020
Lead sponsor:
Agency:
Peking University
Agency class:
Other
Collaborator:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02193594
