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

NCT ID: NCT03973008

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2025-05-31

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.

Conditions

Gastric Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adujvant CT+CRT

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.

Group Type: EXPERIMENTAL

Adjuvant Chemoradiotherapy

Intervention Type: RADIATION

DT 45Gy/25F/5W, using IMRT technology, synchronous tegio single drug chemotherapy

Adjuvant Chemotherapy

Intervention Type: DRUG

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

Adujvant CT

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

Group Type: ACTIVE_COMPARATOR

Adjuvant Chemotherapy

Intervention Type: DRUG

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

Interventions

Adjuvant Chemoradiotherapy

DT 45Gy/25F/5W, using IMRT technology, synchronous tegio single drug chemotherapy

Intervention Type: RADIATION

Adjuvant 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

Intervention Type: DRUG

Other Intervention Names

CRT; CT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiangdong Cheng

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Jinwen Shen

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Luying Liu

Role: CONTACT

luyingliu@163.com

13957113195

Jinwen Shen

Role: CONTACT

shenjw2005@126.com

13616543578

Facility Contacts

Jinwen Shen

Role: primary

shenjw2005@126.com

References

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.

Reference Type: DERIVED

PMID: 34717717 (View on PubMed)

Other Identifiers

ZJCH-GA-CRT

Identifier Type: -

Identifier Source: org_study_id