Ablative radiation therapy for large pancreatic tumors
Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk
This study is testing a new type of radiation therapy for people with large pancreatic tumors to see if it can help treat them better while protecting nearby organs.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | radiation, chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06427460 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel approach called central-boost ablative radiation therapy (CBART) for patients with large pancreatic tumors or those located near sensitive organs. The method utilizes stereotactic body radiation therapy (SBRT) to deliver high doses of radiation specifically to the tumor while minimizing risks to surrounding tissues. By creating targeted high-radiation-dose areas within the tumor, the study aims to improve treatment outcomes for patients who are not candidates for surgical resection. The efficacy and safety of this technique will be evaluated in a Phase 2 clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with pathologically confirmed pancreatic tumors that are large or located near organs at risk.
Not a fit: Patients with a history of radiotherapy for the lesion or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced pancreatic cancer, potentially improving their quality of life and survival rates.
How similar studies have performed: While similar approaches using spatially fractionated radiation therapy have been explored, the specific technique of CBART is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18-75 years. * Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor. * Oligometastasis in the case of metastatic tumor * the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm * ECOG of 0 to 1 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 radiotherapy for the lesion * History of tumor within 5 years * ECOG ≥2 points * Significant abnormality in blood routine test, liver and kidney function test and coagulation test * Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor * Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor * Infections required antibiotics * Heart or respiratory insufficiency * Pregnant 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.