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

University of Chinese Academy Sciences

Status and phase: Enrolling; Phase 3

Conditions: Gastric Adenocarcinoma

Treatments: Radiation: Adjuvant Chemoradiotherapy; Drug: Adjuvant Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03973008

ZJCH-GA-CRT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 408 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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408 participants in 2 patient groups

Adujvant CT+CRT

Experimental group

Description:

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.

Treatment:

Drug: Adjuvant Chemotherapy

Radiation: Adjuvant Chemoradiotherapy

Adujvant CT

Active Comparator group

Description:

The adjuvant chemotherapy was started 4-6 weeks after D2 radical operation. The SOX regimen was repeated every 3 weeks for 8 cycles.

Treatment:

Drug: Adjuvant Chemotherapy