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Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer

ConditionPancreatic Cancer Non-resectable
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShandong Cancer Hospital and Institute

About this trial

This is a Phase II, multicenter, randomized controlled trial to assess the efficacy of Stereotactic Body Radiotherapy (SBRT) in combination with maintenance therapy in patients with advanced pancreatic cancer. The aim is to compare the efficacy of SBRT combined with maintenance therapy versus maintenance therapy alone. The primary outcome is the overall survival (OS) of patients, with secondary endpoints including progression-free survival (PFS), response rates, and quality of life assessments. The study will involve patients with unresectable pancreatic adenocarcinoma who are receiving chemotherapy and have stable disease. The hypothesis is that SBRT, by improving local control, can enhance the benefit of ongoing maintenance therapy and lead to better overall survival outcomes in this patient group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 70 years old.

Histologically or cytologically confirmed diagnosis of pancreatic - adenocarcinoma.

No prior radiation therapy for pancreatic cancer.

At least one measurable lesion of the primary pancreatic tumor as per RECIST 1.1 criteria, eligible for SBRT.

Disqualifiers

Currently participating in any interventional clinical trial or having received other investigational drugs or devices within 4 weeks prior to enrollment.

Peritoneal metastasis.

Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis.

Receiving systemic corticosteroid treatment within 7 days prior to enrollment (except for physiological doses).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic Body Radiotherapy (SBRT) with maintenance therapy

    Radiation

    Patients eligible for this trial will have completed at least four months of first-line chemotherapy, achieving stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria. After completion of the chemotherapy, they will be randomized into two groups: the experimental group will receive SBRT in addition to maintenance chemotherapy. The chemotherapy regimen will be based on the patient's first-line treatment.

  • Maintenance therapy

    Drug

    Patients eligible for this trial will have completed at least four months of first-line chemotherapy, achieving stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria. After completion of the chemotherapy, they will be randomized into two groups: the control group will receive maintenance chemotherapy alone. The chemotherapy regimen will be based on the patient's first-line treatment.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Stereotactic Body Radiotherapy (SBRT) with maintenance therapyExperimental treatment 1 intervention
Group B: maintenance therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1-Year Overall Survival (OS) Rate

The proportion of patients who are alive at 12 months from the start of the study.

Time frame
12 months

Secondary outcomes

1

Overall Survival (OS)

The time from diagnosis to death from any cause.

Time frame
From the date of diagnosis until the date of death from any cause, whichever occurs first, assessed up to 24 months.
2

Progression-Free Survival (PFS)

The time from the start of treatment to disease progression or death.

Time frame
From the start of treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
3

Local Control Rate (LCR)

The proportion of patients whose tumors are controlled at the primary site after treatment.

Time frame
Assessed at the end of treatment and at follow-up visits, up to 24 months.
4

Adverse Event (AE) Rate

The frequency of all adverse events occurring during the treatment period.

Time frame
Monitored throughout the treatment period, and safety follow-up will continue 30 days after the last dose or until the start of a new anti-cancer treatment, whichever occurs first

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Cancer Hospital and Institute

Lead sponsor

Source ClinicalTrials.gov
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