Split-course SBRT for Borderline Resectable and Locally Advanced Pancreatic Cancer

Pancreatic Neoplasms Clinical Trial

Official title:

Chemotherapy-based Split Stereotactic Body Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer: Study Protocol of a Prospective, Single-arm Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04289792
• Other study ID #: splitPC
• Status: Recruiting
• Phase: Phase 2
• Start date: May 9, 2020
• Est. completion date: May 9, 2025

Study information

• Verified date: February 2023
• Source: Fujian Medical University Union Hospital
• Contact: Benhua Xu, PHD
• Phone: +86-13696884375
• Email: benhuaxu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Exploratory assessment of the efficacy and safety of gemcitabine-albumin-based paclitaxel chemotherapy combined with SBRT in the treatment of newly diagnosed borderline resectable and locally advanced unresectable pancreatic cancer patients with sequential investigator selection (IC).

Description:

The question of how to administer adequate chemotherapy to synchronize SBRT treatment strategy to maximize the benefits of neoadjuvant therapy for improved prognosis of patients with borderline resectable (BRPC) and locally advanced (LAPC) pancreatic cancer is a challenging and debatable issue. No studies have yet evaluated the efficacy of split-course SBRT as the neoadjuvant chemoradiotherapy regimen. The investigators aimed to study whether neoadjuvant chemotherapy plus split-course SBRT results in better outcomes in BRPC and LAPC patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: May 9, 2025
• Est. primary completion date: May 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age = 18 years old and = 70 years old.

• Histologically or cytologically confirmed adenocarcinoma of the pancreas.

• Borderline resectable or locally advanced pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines

• No prior chemotherapy or radiotherapy

• ECOG performance status of 0 or 1.

• Without distant metastasis

• The maximum diameter of the tumor must not exceed 5 cm

• Acceptable hematology parameters: a. Absolute neutrophil count (ANC) =1500 cell/mm3 b. Platelet count =100,000/mm3 c. Hemoglobin (Hgb)=9 g/dL

• Acceptable blood chemistry levels: a. AST/SGOT and ALT/SGPT=2.5× upper limit of normal range (ULN) b. Total bilirubin=1.5 ULN c. Alkaline phosphatase=2.5× ULN d. Serum albumin>3 g/dL e. Serum creatinine=1.5 ULN

• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.

Exclusion Criteria:

• Age < 18 years old and > 70 years old. Prior anticancer therapy for pancreatic carcinoma.

• Presence of or history of metastatic pancreatic adenocarcinoma.

• Patients who had surgeries, chemotherapy, or other treatments before inclusion.

• Any other malignancy within 5 years prior to enrollment

• History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients.

• Peripheral sensory neuropathy Grade > 1

• Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders.

• Pregnant or breast feeding.

• Patients enrolled in other clinical trials or incompliant with regular follow-up

• Unwillingness or inability to comply with study procedures.

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• nab-Paclitaxel+Gemcitabine
Drug: nab-Paclitaxel 125 mg/m2 IV over approximately 30-45 min on Days 1 and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 min on Days 1 and 15 of each 28-day cycle for 6 cycles.

Radiation:
• split-course SBRT
Radiation: During the first 1 and 2 cycles of chemotherapy, SBRT was given as a single irradiation of 10 Gy ? 4 times (Days 2 and 16 of each 28-day cycle).

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier Estimate of Progression-Free Survival (PFS)	Progression-free Survival (PFS) was defined as the time from the date of the first dose to the date of disease progression or death (by any cause), whichever is earlier. The analysis day was calculated from enrollment date for one participant who was not treated. Participants who have no disease progression or have not died were censored to last tumor assessment date with progression-free.	From enrollment to 2 years after the end of treatment
Secondary	Kaplan-Meier Estimates for Time to Treatment Failure (TTF)	TTF was defined as the time after the first dose of study therapy to discontinuation of study therapy due to disease progression, death by any cause, or the start of a new non-protocol-defined anticancer therapy/surgery.	From enrollment to 2 years after the end of treatment
Secondary	Disease Control Rate (DCR)	DCR was defined as the percentage of participants with a CR or PR or SD from of date of first treatment to 16 weeks. Tumor assessments after start of non-protocol-defined anticancer therapy were excluded.	From enrollment to 2 years after the end of treatment
Secondary	Overall Response Rate (ORR)	ORR was defined as the percentage of participants that achieved a combined incidence of complete (CR) and partial response (PR) using RECIST 1.1 guidelines as assessed by the investigator.	From enrollment to 2 years after the end of treatment
Secondary	Kaplan-Meier Estimates for Overall Survival (OS)	Overall survival was defined as the time from the date of first dose of study therapy to the date of death (by any cause).	From enrollment to 2 years after the end of treatment
Secondary	Participants With Treatment Emergent Adverse Events (TEAEs)	TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days.	From enrollment to 2 years after the end of treatment