Clinical trial NCT03973008: Adujvant CT+CRT vs Adujvant CT After D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Adenocarcinoma
Keywords: Gastric Adenocarcinoma
Adjuvant Radiotherapy
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: disease-free survival
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Jinwen Shen
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiangdong Cheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.