Stereotactic Radiotherapy vs Best Supportive Care in Unfit Pancreatic Cancer Patients

NCT05265663 | Unknown DMC

• 1 other identifier: NL72181.029.20
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

SABR, SBRT

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The primary endpoint is to compare survival at six months in both study arms, measured from the time of randomization.

  six months after randomization

Secondary Outcomes (9)

• Global quality of life

  prior to treatment, 3-6-12 months after randomization

• Pain score

  prior to treatment, 3-6-12 months after randomization

• Quality of Life related to symptoms caused by cancer

  prior to treatment, 3-6-12 months after randomization

• Quality of Life related to symptoms caused by pancreatic cancer

  prior to treatment, 3-6-12 months after randomization

• Level of CA19.9

  prior to treatment, 3, 6 and 12 months after treatment

Study Arms (2)

best supportive care

NO INTERVENTION

Standard of care or best supportive care (or palliative care) is care that focuses on relieving symptoms caused by serious illnesses like cancer, in this case PDAC. It can be given at any point during a person's illness to help them feel more comfortable. For instance, prescription of medicines to help control or prevent nausea and vomiting or to help relieve pain. All patients will be treated with pancreatic enzymes like Creon and a proton pomp inhibitor. Current guidelines for best supportive care include follow-up visits at three-monthly intervals in order to optimize symptom relief.

stereotactic ablative radiotherapy

EXPERIMENTAL

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.

Radiation: stereotactic ablative radiotherapy

Interventions

stereotactic ablative radiotherapy RADIATION

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.

stereotactic ablative radiotherapy

Eligibility Criteria

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

You may qualify if:

• Pathology proven localised (non-metastasized) PDAC
• Patients unfit for both surgery and systemic chemotherapy (i.e. KPS 50-70; WHO 2) • • Patients who choose to refrain from surgery or chemotherapy
• Written informed consent

You may not qualify if:

• Age \<18 years
• Distant metastasis
• Imminent bowel obstruction
• Active bleeding
• Uncontrolled infection
• Contra-indications for MRI (only for VUmc and UMCU)
• Pacemakers or implanted defibrillators, deep brain stimulators, cochlear implants.
• Patients who have a metallic foreign body in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
• Patients with severe claustrophobia not able to tolerate an MRI scan
• Patients with a non-MR-compatible (hip/knee/jaw) prosthesis

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• UMC Utrecht: collaborator
• Erasmus Medical Center: collaborator
• Dutch Cancer Society: collaborator
• Viewray Inc.: collaborator

Study Sites (2)

VUMedicalCenter

Amsterdam, North Holland, 1117 HV, Netherlands

RECRUITING

UMCU

Utrecht, 3584CX, Netherlands

RECRUITING

Related Publications (1)

• Doppenberg D, Besselink MG, van Eijck CHJ, Intven MPW, Koerkamp BG, Kazemier G, van Laarhoven HWM, Meijerink M, Molenaar IQ, Nuyttens JJME, van Os R, van Santvoort HC, van Tienhoven G, Verkooijen HM, Versteijne E, Wilmink JW, Lagerwaard FJ, Bruynzeel AME; Dutch Pancreatic Cancer Group. Stereotactic ablative radiotherapy or best supportive care in patients with localized pancreatic cancer not receiving chemotherapy and surgery (PANCOSAR): a nationwide multicenter randomized controlled trial according to a TwiCs design. BMC Cancer. 2022 Dec 29;22(1):1363. doi: 10.1186/s12885-022-10419-4.

  PMID: 36581914 DERIVED

Study Officials

• Anna ME Bruynzeel, MD PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna ME Bruynzeel, MD PhD

CONTACT

0031204440414; ame.bruynzeel@amsterdamumc.nl

Marc G Besselink, Prof MD PhD

CONTACT

0031204444444; m.g.besselink@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: This study is a prospective multicenter randomized controlled trial according to the 'cohort multiple randomized controlled trial (cmRCT)'-design.

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 3, 2022
• Study Start: October 13, 2020
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 3, 2022

Record last verified: 2022-02

Locations

NL (2)