Comparing target methods in radiation therapy for advanced pancreatic cancer
GTV Uniform Expansion to Form PTV vs. Non-uniform Expansion to Form PTV Based on Recurrence Pattern in SBRT of Locally Advanced Pancreatic Cancer: a Phase II Clinical Prospective Study
This study is testing whether a new way of targeting radiation therapy can help people with advanced pancreatic cancer live longer and respond better to treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04699539 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of two different target delineation methods in stereotactic body radiation therapy (SBRT) for patients with locally advanced pancreatic cancer (LAPC). By comparing these methods, the study seeks to determine if a target delineation approach based on recurrence patterns can lead to improved survival outcomes. Participants will receive SBRT in conjunction with chemotherapy, and their responses will be monitored to assess the effectiveness of the treatment. The study is designed for patients who have not undergone prior anti-tumor treatments related to the pancreas.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of locally advanced pancreatic cancer who have not received prior treatment.
Not a fit: Patients with severe liver or kidney dysfunction, or those who have previously received treatment for pancreatic cancer, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates for patients with locally advanced pancreatic cancer.
How similar studies have performed: While there have been studies on SBRT for pancreatic cancer, the specific comparison of target delineation methods based on recurrence patterns is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 * Patients with a pathological diagnosis of pancreatic ductal adenocarcinoma or clinical diagnosis of pancreatic cancer after clinical multiple disciplinary team * Patients with a clinical staging of locally advanced pancreatic cancer * No anti-tumor treatment related to pancreas before SBRT * Performance status is acceptable, ECOG score is 0 or 1 * Patients who voluntarily accepted the clinical trial program after informing the existing treatment plan Exclusion Criteria: * Patients who have previously received relevant treatments in the pancreas and its surrounding areas, such as radiotherapy, chemotherapy, and local treatment * Severe liver and kidney dysfunction * Obstructive jaundice * Moderate or mass ascites * Patients with other malignant tumors, acute infection or other severe infection * Patients with gastrointestinal ulcers and incomplete recovery, or patients with acute peptic ulcer * Gastroscopy or imaging examination indicates that the tumor invaded the duodenum or stomach * Patients who have participated in other clinical trials for less than three months * Patients who are judged by researchers as unsuitable for this clinical trial
Where this trial is running
Shanghai, Shanghai
- Changhai hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Huojun Zhang, M.D.
- Email: chyyzhj@163.com
- Phone: 021-31162207
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.