Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02745847|
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: Re-irradiation with SBRT||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Re-irradiation with SBRT|
|Masking:||None (Open Label)|
|Official Title:||The Safety and Efficacy of Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Re-irradiation with SBRT
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. [ Time Frame: 3 years ]The toxicities following SBRT will be assessed by CTCAE v4.0
- Overall survival [ Time Frame: 3 years ]The median survival time will be determined.
- Local recurrence-free survival [ Time Frame: 3 years ]The local recurrence-free survival will be determined.
- Objective response rates [ Time Frame: 3 years ]The rate is the ratio of the number of patients with complete remission and partial remission to the total number of enrolled patients.
- The quality of life will be analyzed. [ Time Frame: 3 years ]The analysis of quality of life is based on QLQ-C30.
- The quality of life will be analyzed. [ Time Frame: 3 years ]The analysis of quality of life is based on QLQ-PAN26.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745847
|Contact: Yu Xin Shen, M.D.||+firstname.lastname@example.org|
|Shanghai, Shanghai, China|
|Contact: Yuxin Shen, Master +8615800523983 email@example.com|
|Principal Investigator:||Huo Jun Zhang, MD., PH.D||Changhai Hospital|