Comparing two treatments for advanced gastric cancer after surgery
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
This study is testing if adding radiation to chemotherapy helps people with advanced stomach cancer after surgery have a better chance of staying cancer-free.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 408 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT03973008 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of adding chemoradiotherapy to chemotherapy for patients with locally advanced proximal gastric adenocarcinoma following a D2 radical resection. The aim is to determine if this combination can reduce the high local recurrence rates associated with this type of cancer. Participants will receive either adjuvant chemoradiotherapy or adjuvant chemotherapy alone, and their outcomes will be compared. The study focuses on patients who have undergone surgery and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with locally advanced proximal gastric adenocarcinoma who have undergone a D2 radical resection.
Not a fit: Patients with distant metastasis or those who have received neoadjuvant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cancer recurrence in patients with advanced gastric cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- Jinwen Shen — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Xiangdong Cheng — Zhejiang Cancer Hospital
- Study coordinator: Luying Liu
- Email: luyingliu@163.com
- Phone: 13957113195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.