Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer

NCT02745847 | Unknown

• 1 other identifier: ChangH Hosp
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• The toxicities following SBRT will be determined.

  The toxicities following SBRT will be assessed by CTCAE v4.0

  3 years

Secondary Outcomes (5)

• Overall survival

  3 years

• Local recurrence-free survival

  3 years

• Objective response rates

  3 years

• The quality of life will be analyzed.

  3 years

• The quality of life will be analyzed.

  3 years

Study Arms (1)

Re-irradiation with SBRT

EXPERIMENTAL

Patients with relapsed pancreatic cancer meeting all inclusion criteria will receive re-irradiation with SBRT.

Radiation: Re-irradiation with SBRT

Interventions

Re-irradiation with SBRT RADIATION

Patients previously treated with SBRT with relapsed pancreatic cancer will be re-irradiated with SBRT.

Re-irradiation with SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Huojun Zhang

Shanghai, Shanghai Municipality, China

Location

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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Re-Irradiation; Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Retreatment; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Huo Jun Zhang, MD., PH.D

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Radiation Oncology Department

Model Details: Re-irradiation with SBRT

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 20, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

CN (1)