Comparing adjuvant chemoradiotherapy and chemotherapy for pancreatic cancer
Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer
This study is testing whether a combination of chemotherapy and radiation works better than just chemotherapy for patients with pancreatic cancer who have had surgery and are at high risk of their cancer coming back.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 770 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06427447 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the effectiveness of adjuvant chemoradiotherapy versus chemotherapy in patients with resected pancreatic cancer who are at high risk for disease progression. The study focuses on patients with specific risk factors such as lymph node metastases, R1 or R2 resection, or lymphovascular invasion. By evaluating patient outcomes, the trial seeks to clarify which treatment may offer better survival benefits. The study is conducted at Changhai Hospital in Shanghai, China.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed pancreatic ductal adenocarcinoma and specific risk factors after surgical resection.
Not a fit: Patients with a history of cancer treatment after surgical resection or those with disease progression will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify a more effective treatment option for patients with high-risk pancreatic cancer, potentially improving survival rates.
How similar studies have performed: Previous meta-analyses have suggested that adjuvant chemoradiotherapy may provide survival benefits over chemotherapy for certain high-risk patients, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18-75 years * Pathologically confirmed pancreatic ductal adenocarcinoma * Pathologically confirmed lymph node metastasis, R1 or R2 resection or lymphovascular invasion (one of the risk factors) * No history of cancer treatment after surgical resection * No disease progression confirmed by imaging examinations * ECOG 0 to1 point * No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2) Exclusion Criteria: * History of cancer treatment after surgical resection * History of other cancers within 5 years * Disease progression, including local pprogression or metastasis, confirmed by imaging examinations * ECOG ≥2 points * Significant abnormality in blood routine test, liver and kidney function test and coagulation test * Active inflammatory bowel disease * Gastrointestinal bleeding or perforation within 6 months * Infections requiring antibiotics * Heart or respirotory insufficiency * Pregnant women or breastfeeding women
Where this trial is running
Shanghai, Shanghai Municipality
- Huojun Zhang — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Huojun Zhang, M.D. — Changhai Hospital
- Study coordinator: Xiaofei Zhu
- Email: zhuxiaofei_zxf@163.com
- Phone: 86-021-31162222
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.