Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectable Pancreatic Cancer

NCT05424159 | Recruiting DMC

• 1 other identifier: SPHIC-TR-PaCa2022-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer with pencil beam scanning and simultaneous integrated boost (SIB) technology.

Conditions

Pancreatic Cancer Non-resectable

Keywords

Locally advanced unresectable pancreatic cancer; Carbon ion radiotherapy; Phase II clinical trial; Ablative dose; Optimized linear energy transfer

Outcome Measures

Primary Outcomes (1)

• 2-year cumulative local regional progression rate (LRP)

  LRP was defined as the percentage of patients with local disease progression (within irradiated area) in the intentional population.

  From the date of the initiation of radiotherapy until the date of first documented occurrence of local regional progression, assessed up to 24 months.

Secondary Outcomes (3)

• 2-year Overall survival (OS)

  From the date of diagnosis until the date of death from any cause, assessed up to 24 months.

• Acute toxicity

  From the date of the initiation of radiotherapy until the date of 3 months after radiotherapy.

• Late toxicity

  3 months after radiotherapy.

Study Arms (1)

Patients with locally advanced unresectable pancreatic cancer

EXPERIMENTAL

Patients with locally advanced unresectable pancreatic cancer without invasion of the gastrointestinal tract, cT4N0-2M0 Stage III (AJCC/UICC Version 8).

Radiation: Carbon ion radiotherapy

Interventions

Carbon ion radiotherapy RADIATION

Patients with locally advanced unresectable pancreatic cancer without invasion of gastrointestinal tract will received ablative carbon ion radiotherapy. The prescription dose for primary pancreatic lesion, positive lymph node, and retroperitoneal high-risk recurrence area is 67.5 Gy (RBE weighted dose) in 15 fractions for 3 weeks; Pancreatic primary lesion and positive lymph node SIB to 75 Gy (RBE weighted dose) in 15 fractions for 3 weeks.

Patients with locally advanced unresectable pancreatic cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have the ability to sign the written informed consent;
• Ductal adenocarcinoma of the pancreas confirmed by histopathology or cytopathology;
• Distant metastasis was excluded by imaging assessment (PET-CT, cranial MRI), and was defined as locally advanced unresectable according to NCCN Guidelines Version 2022.1, that is, T4N0-2M0, Stage III (AJCC/UICC Version 8);
• The maximum diameter of pancreatic primary lesion and positive lymph node ≤7cm;
• Pancreas primary lesion or positive lymph node did not invade digestive tract (stomach, duodenum and small intestine);
• Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
• Adequate bone marrow function (neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥10.0g/dL);
• Adequate liver function (total bilirubin \<1.5 times the upper limit of normal value, aminotransferase \<2.5 times the upper limit of normal value);
• Adequate renal function (serum creatinine \<2mg/dL, or creatinine clearance \>50mL/min).

You may not qualify if:

• Multiple primary pancreatic lesions (\>1);
• Tumor invaded the adjacent digestive tract;
• Radiation therapy history;
• Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation;
• The irradiation dose of organs at risk cannot reach the dose constraint;
• Other malignant tumors history;
• Inability to understand the purpose of treatment or unwillingness/inability to sign informed consent.

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, 201315, China

RECRUITING

MeSH Terms

Interventions

Heavy Ion Radiotherapy

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Zheng Wang, MD, PhD

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

• Xin Cai, MD

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Wang, MD, PhD

CONTACT

+86-02138296666; zheng.wang@sphic.org.cn

Guo-Liang Jiang, MD

CONTACT

+86-02138296606; guoliang.jiang@sphic.org.cn

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: Principal Investigator

Model Details: Radiation: carbon ion radiotherapy for tumors without invasion of GI

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)