Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer

Study Overview
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Brief Summary
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The safety and efficacy of re-irradiation with stereotactic body radiotherapy for relapsed pancreatic cancer will be evaluated.

Detailed Description
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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.

Official Title
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The Safety and Efficacy of Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Radiation: Re-irradiation with SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 KPS≥70 Pancreatic malignancy need to be confirmed by histological or cytological valuation or clinical diagnosis (MDT with typical clinical manifestations, radiological features of pancreatic cancer via MRI and PET-CT). Patients were previously treated with SBRT in Shanghai Changhai hospital The time from the end of prior SBRT to local recurrence is more than 6 months In-field recurrences of pancreatic cancer confirmed by Imaging examinations. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×10^9/L, leukocyte count≥ 3.5 ×10^9/L, platelets ≥ 70×10^9/L, hemoglobin ≥ 80 g/L Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×10^9/L, leukocyte count≥ 3.5 ×10^9/L, platelets ≥ 70×10^9/L, hemoglobin ≥ 80 g/L INR < 2 (0.9-1.1), PPT <1.5 × ULN Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Age<18 KPS<70 Prior anti-tumor treatment (surgery, chemotherapy, radiation etc.) for the relapsed pancreatic cancer. Evidences of metastatic disease or invasion of the stomach or duodenum confirmed by Imaging examinations. The time from the end of prior SBRT to local recurrence is less than 6 months Patients with active inflammatory bowel diseases or peptic ulcer Gastrointestinal bleeding or perforation within 6 months Abnormal results of blood routine examinations and liver and kidney tests Female who is pregnant or nursing, or is of childbearing potential and not using a reliable method of contraception Patients with a history of any other malignancy (except basal cell carcinoma and carcinoma in situ of cervix) Contraindication to SBRT Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Re-irradiation with SBRT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Re-irradiation with SBRT<br>Patients with relapsed pancreatic cancer meeting all inclusion criteria will receive re-irradiation with SBRT. | Radiation: Re-irradiation with SBRT<br>* Patients previously treated with SBRT with relapsed pancreatic cancer will be re-irradiated with SBRT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The toxicities following SBRT will be determined. | The toxicities following SBRT will be assessed by CTCAE v4.0 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The median survival time will be determined. | 3 years | 
| Local recurrence-free survival | The local recurrence-free survival will be determined. | 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. | 3 years | 
| The quality of life will be analyzed. | The analysis of quality of life is based on QLQ-C30. | 3 years | 
| The quality of life will be analyzed. | The analysis of quality of life is based on QLQ-PAN26. | 3 years |