Comparing neoadjuvant chemoradiotherapy and chemotherapy for advanced gastric cancer
An Randomized, Multicenter, Open-label, Phase III Trial Comparing Neoadjuvant Chemoradiotherapy Versus Chemotherapy in Patients With Locally Advanced Gastric Adenocarcinoma
This study is testing whether combining radiation with chemotherapy before surgery can help people with advanced stomach cancer live longer and healthier compared to just using chemotherapy alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 620 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT01815853 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of neoadjuvant chemoradiotherapy combined with chemotherapy versus chemotherapy alone in patients with locally advanced gastric cancer. Participants with confirmed gastric adenocarcinoma are randomly assigned to receive either treatment before undergoing radical gastrectomy and subsequent adjuvant chemotherapy. The primary focus is on disease-free survival, while secondary outcomes include overall survival, pathological complete response, and treatment safety. The study aims to clarify the potential benefits of neoadjuvant chemoradiotherapy in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed locally advanced gastric adenocarcinoma and adequate organ function.
Not a fit: Patients with a history of other malignancies or those who have previously received chemotherapy or radiation for gastric cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and treatment outcomes for patients with advanced gastric cancer.
How similar studies have performed: Previous studies have suggested potential benefits of neoadjuvant chemoradiotherapy in similar patient populations, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * informed consensus of the enrolled patients * being able to receive oral drug * from 18 to 75 years old * proven to be primary adenocarcinoma of gastric cancer and pre-operative staging cT3N2/N3M0, cT4aN+M0, cT4bNanyM0, * no prior other chemotherapy and/or radiation against the disease * normal function of all other vital organs including heart,liver ,kidney and so on * Eastern Cooperative Oncology Group performance status: 0\~2 Exclusion Criteria: * history of other malignancy * allergic reaction to capecitabine or oxaliplatin * enrolled in other clinical trials * abnormal GI tract function * dysfunction of other organs * pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy * other situations judged as not adaptive to the study by investigators
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Zhi-wei Zhou, M.D, Ph.D — Sun Yat-sen University
- Study coordinator: Zhi-wei Zhou, M.D, Ph.D
- Email: zhouzhw@sysucc.org.cn
- Phone: 0086-20-87343626
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.