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Stereotactic Radiotherapy vs Best Supportive Care in Unfit Pancreatic Cancer Patients

NCT05265663 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2022-03-03

No results posted yet for this study

Summary

SUMMARY Rationale: Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal cancers, its incidence increases with age. Many patients with localized (non-metastatic) PC have significant comorbidities, advanced age or a poor performance status which preclude chemotherapy and surgery. Because these patients are currently left untreated, it is desirable to find tolerable treatment options for these patients. A short course of high-dose precise radiation therapy i.e. stereotactic ablative body radiotherapy (SABR) may be feasible in these patients. Review of existing SABR literature for PDAC shows high local control rates, with relatively low toxicity and it was demonstrated to be feasible and well tolerated even in elderly patients. It is unknown whether SABR improves outcomes in this group. The main goal of the current study is to investigate if SABR may relieve tumor-related symptoms, postpone a decrease in global QoL and potentially prolong survival in this patient group compared to the current treatment of choice, best supportive care.

Objective: To investigate the potential benefit in survival and quality of life after SABR in patients with localised PDAC for whom no other treatment is available, as compared to controls managed with best supportive care.

Study design: A multicentre randomized controlled trial Study population: Patients with biopsy proven, localized PDAC, unfit for chemotherapy and surgery or those who refuse these treatments. They will be randomized between SABR versus best supportive care.

Intervention: consists of SABR to the primary tumour in 5 fractions of 8 Gy. Main study endpoints: Primary endpoint is the overall survival rate at six months (from randomization). Secondary endpoints include the evaluation of time to decreased global quality of life (QoL, using the QLQ- C30 and EORTC-PAN26), NRS pain response and Ca19.9 response, acute and subacute toxicity using CTCAEv5.0 and progression-free survival in the treated patients using imaging.

It is hypothesized that in frail patients with PDAC, SABR may relieve tumor-related symptoms, improve the quality of life and prolong survival compared to best supportive care. Its aim is to investigate the outcomes of SABR with respect to overall survival, pain response, toxicity and quality of life in patients with non-metastasized PDAC for whom standard radical treatment in the form of surgery or chemotherapy is either too toxic, not possible due to comorbidities, or is refused.

Conditions

  • Pancreatic Cancer Non-resectable

Interventions

RADIATION

stereotactic ablative radiotherapy

SABR will be delivered in an image-guided hypofractionated scheme of 5 fractions of 8 Gy (total 40 Gy), prescribed to 95% of the planning target volume (PTV). Treatment is delivered on alternate days within a maximum overall treatment duration of 14 days.

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Dutch Cancer Society

    collaborator OTHER

  • Viewray Inc.

    collaborator INDUSTRY

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Anna ME Bruynzeel, MD PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-13
Primary Completion
2024-03-01
Completion
2024-06-01

Countries

  • Netherlands

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05265663 on ClinicalTrials.gov