Adujvant CT+CRT vs Adujvant CT After D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma
Phase III, Randomized, Open-label Study of Adjuvant Chemotherapy Combined With Chemoradiotherapy Versus Adujvant Chemotherapy After Standard D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma
1 other identifier
interventional
408
1 country
1
Brief Summary
This study evaluates the addition of adjuvant chemoradiotherapy to adjuvant chemotherapy in the treatment of locally advanced proximal gastric adenocarcinoma after standard D2 radical resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2019
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2019
CompletedFirst Submitted
Initial submission to the registry
June 1, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedJune 4, 2019
May 1, 2019
5 years
June 1, 2019
June 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease-free survival
after primary treatment the patient survives without any signs or symptoms of cancer.
3 year
Study Arms (2)
Adujvant CT+CRT
EXPERIMENTALFour to six weeks after D2 radical surgery, adjuvant chemotherapy was initiated with SOX regimen , repeated every three weeks, and adjuvant radiotherapy was started at the end of two cycles of adjuvant chemotherapy , with synchronous tegiol single drug chemotherapy. And the original SOX regimen was continued for 4 cycles after 3-4 weeks of radiotherapy.
Adujvant CT
ACTIVE COMPARATORThe adjuvant chemotherapy was started 4-6 weeks after D2 radical operation. The SOX regimen was repeated every 3 weeks for 8 cycles.
Interventions
DT 45Gy/25F/5W, using IMRT technology, synchronous tegio single drug chemotherapy
Oxalis 130mg/m2 intravenous drip on day 1, tegio 80-120 mg daily, twice, half an hour after breakfast and dinner, for 14 consecutive days
Eligibility Criteria
You may qualify if:
- Voluntary Participation and Written Signature of Informed Consent.
- Age 18-70, gender unlimited.
- Gross pathology confirmed that the tumor center was within 1 cm to 5 cm of the EGJ line. Histopathologically diagnosed as adenocarcinoma.
- No neoadjuvant therapy.
- Transabdominal standard D2 radical operation was performed and R0 resection was performed. Ascites cytology was negative.
- The pathological stages were IIB, IIIA, IIIB and IIIC.
- There was no intraperitoneal implantation and distant metastasis. CT should be routinely performed to evaluate the tumor bed before radiotherapy. Positron emission tomography (PET-CT) could be accepted to determine whether there was residual or distant metastasis.
- Physical condition score ECOG 0-1.
- No history of serious heart and lung diseases, abnormal hematological examination and immunodeficiency: hemoglobin (Hb) \> 9 g/dL; white blood cell (WBC) \> 3 x 109/L; neutrophil (ANC) \> 1.5 x 109/L; platelet (Pt) \> 100 x 109/L; bilirubin \< 1.5 times the upper limit of normal value; glutathione transaminase (ALT) \& alanine transaminase (AST) = 2.5 times the upper limit of normal value; serum creatinine \< 1.5 times the normal value Upper limit.
- No other systemic tumors were found.
- Fertile men or women are willing to take contraceptive measures in the trial.
- The daily energy intake is more than 1500 kcal.
You may not qualify if:
- Those who had a history of malignant tumors (except skin basal cell carcinoma, thyroid papillary adenocarcinoma and cervical carcinoma in situ, who survived for more than 3 years after treatment).
- Patients with a history of neoadjuvant radiotherapy and chemotherapy before operation.
- Study participants who participated in other clinical trials within 30 days before treatment.
- Pregnancy, lactation or fertility without contraceptive measures.
- Drug addiction and other adverse drug addiction, long-term alcoholism and AIDS patients.
- Those with uncontrollable infections, seizures, or loss of self-awareness due to mental illness.
- Those with a history of severe allergy or specific constitution.
- Researchers believe that it is not appropriate to participate in this experiment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinwen Shen
Hangzhou, Zhejiang, 310022, China
Related Publications (1)
Shen J, Zhu X, Du Y, Zhu Y, Yu P, Yang L, Xu Z, Huang L, Zhang Y, Zhang Y, Liu L, Cheng X. Adjuvant SOX chemotherapy versus concurrent chemoradiotherapy after D2 radical resection of locally advanced esophagogastric junction (EGJ) adenocarcinoma: study protocol for a randomized phase III trial (ARTEG). Trials. 2021 Oct 30;22(1):753. doi: 10.1186/s13063-021-05617-7.
PMID: 34717717DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangdong Cheng
Zhejiang Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2019
First Posted
June 4, 2019
Study Start
March 11, 2019
Primary Completion
February 29, 2024
Study Completion
May 31, 2025
Last Updated
June 4, 2019
Record last verified: 2019-05