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

• Status: Recruiting
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital

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.