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Trial record 65 of 2835 for:    Pancreatic Cancer

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 : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Zhang Huo Jun, Changhai Hospital

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Re-irradiation with SBRT Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : January 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. The toxicities following SBRT will be determined. [ Time Frame: 3 years ]
    The toxicities following SBRT will be assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
    The median survival time will be determined.

  2. Local recurrence-free survival [ Time Frame: 3 years ]
    The local recurrence-free survival will be determined.

  3. 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.

  4. The quality of life will be analyzed. [ Time Frame: 3 years ]
    The analysis of quality of life is based on QLQ-C30.

  5. The quality of life will be analyzed. [ Time Frame: 3 years ]
    The analysis of quality of life is based on QLQ-PAN26.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age≥18
  2. KPS≥70
  3. 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).
  4. Patients were previously treated with SBRT in Shanghai Changhai hospital
  5. The time from the end of prior SBRT to local recurrence is more than 6 months
  6. In-field recurrences of pancreatic cancer confirmed by Imaging examinations.
  7. 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
  8. 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
  9. INR < 2 (0.9-1.1), PPT <1.5 × ULN
  10. Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Age<18
  2. KPS<70
  3. Prior anti-tumor treatment (surgery, chemotherapy, radiation etc.) for the relapsed pancreatic cancer.
  4. Evidences of metastatic disease or invasion of the stomach or duodenum confirmed by Imaging examinations.
  5. The time from the end of prior SBRT to local recurrence is less than 6 months
  6. Patients with active inflammatory bowel diseases or peptic ulcer
  7. Gastrointestinal bleeding or perforation within 6 months
  8. Abnormal results of blood routine examinations and liver and kidney tests
  9. Female who is pregnant or nursing, or is of childbearing potential and not using a reliable method of contraception
  10. Patients with a history of any other malignancy (except basal cell carcinoma and carcinoma in situ of cervix)
  11. Contraindication to SBRT
  12. Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document

Information from the National Library of Medicine

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


Contacts
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Contact: Yu Xin Shen, M.D. +8615800523983 syx2005@gmail.com

Locations
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China, Shanghai
Huojun Zhang Recruiting
Shanghai, Shanghai, China
Contact: Yuxin Shen, Master    +8615800523983    syx2005@gmail.com   
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Huo Jun Zhang, MD., PH.D Changhai Hospital

Publications:
HUGUET F H P V D. Impact of chemoradiation on local control and time without treatment in patients with locally advanced pancreatic cancer included in the international phase III LAP 07 study. Journal of Clinical Oncology 5s(32): 4001, 2014.

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Responsible Party: Zhang Huo Jun, Director of Radiation Oncology Department, Changhai Hospital
ClinicalTrials.gov Identifier: NCT02745847     History of Changes
Other Study ID Numbers: ChangH Hosp
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases