An interventional study of Re-irradiation with SBRT in Pancreatic Cancer, sponsored by Changhai Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment
The safety and efficacy of re-irradiation with stereotactic body radiotherapy for relapsed pancreatic cancer will be evaluated.
Pancreatic cancer is one of the most lethal malignant tumors, probably attributable to local recurrence deemed as a predominant factor influencing patients' prognosis and quality of life. Only 15%-20% patients are suitable for surgeries among those first diagnosed with pancreatic cancer and the 5-year survival rate of those patients with R0 resection is still less than 20%. Therefore, radiotherapy is becoming a promising method to improve survival. However, due to adjacent organs at risk, conventional external beam radiotherapy, besides long courses, sometimes results in severe radiation-induced toxicity, delaying the initial of thereafter treatment, such as chemotherapy, which reduces clinical benefits.
A single-fraction dose in the gross tumor volume could be increased stereotactic body radiotherapy (SBRT). Furthermore, doses of organs at risk could also be reduced, thus effectively improving local control rates and reducing radiation related toxicity. Compared with conventional external beam radiotherapy, SBRT is proved to provide longer progression free survival and safe with combination of chemotherapy. Moreover, owing to short courses and low toxicity of SBRT, quality of life is largely improved.
However, it was reported that progression usually occurred 2 years after the initial treatment. The most common failure pattern was local recurrence. Chemotherapy and supportive treatment were commonly used in relapsed pancreatic cancer but with unfavored outcomes. Palliative surgeries are performed in patients with recurrent pancreatic cancer in some studies. Nevertheless, because of bad medical conditions and high complication rates, many patients could not endure surgeries. Therefore, whether patients previously treated with SBRT could be re-irradiated is another challenge in the treatment of pancreatic cancer.
Some studies have confirmed that improved quality of life and longer survival could be available with re-irradiation via SBRT in patients with relapsed pancreatic cancer. Real-time guiding and synchronous tracing of SBRT increase the doses of tumor volumes but decrease doses of organs at risk and toxicity, rendering SBRT as an alternative treatment for relapsed pancreatic cancer. Chris et al. demonstrated that 1-year local control rate was 70% after re-irradiation with SBRT in 14 patients and the toxicity was mild. Nergiz Dagoglu et al. showed that the median overall survival was 14 months and no grade 3, 4 and 5 toxicities occurred.
From 2013-2015, we retrospectively reviewed medical records of 14 patients with relapsed pancreatic cancer re-irradiated with SBRT. All of their tumor markers and pain scores decreased and quality of life improved 3 months after re-irradiation. Hence, based on our experience, we attempt to prospectively evaluate the safety and efficacy of re-irradiation with SBRT for relapsed pancreatic cancer.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's planned enrollment of 30 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
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Exclusion Criteria:
Patients with relapsed pancreatic cancer meeting all inclusion criteria will receive re-irradiation with SBRT.
Radiation: Re-irradiation with SBRT
Patients previously treated with SBRT with relapsed pancreatic cancer will be re-irradiated with SBRT.
The toxicities following SBRT will be determined.
The toxicities following SBRT will be assessed by CTCAE v4.0
Time frame: 3 years
Overall survival
The median survival time will be determined.
Time frame: 3 years
Local recurrence-free survival
The local recurrence-free survival will be determined.
Time frame: 3 years
Objective response rates
The rate is the ratio of the number of patients with complete remission and partial remission to the total number of enrolled patients.
Time frame: 3 years
The quality of life will be analyzed.
The analysis of quality of life is based on QLQ-C30.
Time frame: 3 years
The quality of life will be analyzed.
The analysis of quality of life is based on QLQ-PAN26.
Time frame: 3 years
Plan to share: Undecided
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Changhai Hospital