Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer

May 24, 2023 updated by: Zhang Huo Jun, Changhai Hospital

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Huojun Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Huo Jun Zhang, MD., PH.D, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimated)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChangH Hosp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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