Adujvant CT+CRT vs Adujvant CT After D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma

Study Overview
=================
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.

Detailed Description
-----------------
Because of its special anatomical structure, local recurrence rate of locally advanced proximal gastric adenocarcinoma is still high after radical operation. As a local/regional therapy, radiotherapy combined with concurrent chemotherapy can kill local residual tumor cells and reduce the risk of local and regional recurrence.

Official Title
-----------------
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

Conditions
-----------------
Gastric Adenocarcinoma

Intervention / Treatment
-----------------
* Radiation: Adjuvant Chemoradiotherapy
* Drug: Adjuvant Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adujvant CT+CRT<br>Four 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. | Radiation: Adjuvant Chemoradiotherapy<br>* DT 45Gy/25F/5W, using IMRT technology, synchronous tegio single drug chemotherapy<br>* Other names: CRT;Drug: Adjuvant Chemotherapy<br>* 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<br>* Other names: CT;|
| Active Comparator: Adujvant CT<br>The adjuvant chemotherapy was started 4-6 weeks after D2 radical operation. The SOX regimen was repeated every 3 weeks for 8 cycles. | Drug: Adjuvant Chemotherapy<br>* 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<br>* Other names: CT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | after primary treatment the patient survives without any signs or symptoms of cancer. | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Adenocarcinoma, Adjuvant Radiotherapy