Carbon Ion RT for Locally Advanced Pancreatic Cancer

A Prospective, Randomized, Phase 3 Trial of Carbon Ion Radiation Therapy Versus Standard Care for Locally Advanced Pancreatic Cancer

This is an open-label randomized trial. Subjects will be randomized in a 2:1 ratio to receive carbon ion radiotherapy versus standard care for locally advanced pancreatic cancer. Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians. Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Radiation: carbon ion RT; Drug: Chemotherapy drug

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201315
      • Shanghai Proton and Heavy Ion Center (SPHIC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas
• Sum of maximum diameters of tumor and involved lymph nodes ≤6 cm T1-4N0-1M0,
• Unresectable disease by radiographic criteria (pancreas protocol CT or MRI) or surgical exploration within 30 days prior to registration, defined based on at least one of the following:

major venous thrombosis of the portal vein or SMV extending for several centimeters (precluding vein resection and reconstruction) encasement (>180°) of the SMA or proximal hepatic artery abutment of the celiac trunk

• No evidence of distant metastases, based upon axial (PET, CT, or MRI) imaging of the chest, abdomen, and pelvis within 30 days prior to registration
• ECOG Performance Status 0-1 within 30 days prior to registration
• Age ≥ 18
• CBC/differential obtained within 14 days prior to step 1 registration, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• Platelets ≥ 100,000 cells/mm3
• Hemoglobin ≥ 9.0 g/dl (NOTE: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable)
• Additional laboratory studies within 14 days prior to registration demonstrating:

Creatinine < 2 mg/dl; GFR > 50 mL/min (Cockroft and Gault formula)

• Bilirubin < 1.5 x ULN
• ALT and AST ≤ 2.5 x ULN
• aPTT, PT ≤ 1.5 x ULN
• Patients must provide study specific informed consent prior to study entry.
• Women of childbearing potential and male participants must practice adequate contraception during protocol treatment and for at least 6 months following treatment For females of child-bearing potential, negative serum pregnancy test within 30 days prior to registration

Exclusion Criteria:

• More than one primary lesion
• Tumor invasion of the duodenum or stomach, confirmed by upper endoscopy
• Active malignancy, other than pancreatic cancer, for which systemic therapy is indicated. -History of adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy asides from hormonal therapy, adequately treated stage 1or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years is permitted.
• Prior treatment for pancreatic cancer with surgical resection, external radiotherapy, or interstitial isotope implantation.
• Prior treatment for pancreatic cancer with a systemic therapy regimen/agent not included in the list below. Systemic therapy must be discontinued at least 14 days before study enrollment.
• FOLFIRINOX
• Gemcitabine/nab-paclitaxel
• Gemcitabine
• S-1
• Prior radiation therapy to the abdomen that would result in overlap of radiation therapy fields

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbon ion radiotherapy; Carbon ion radiotherapy will be administered 5 days each week (Monday-Friday). The prescription dose will be 60 GyE in 20 fractions, to be delivered over four weeks.	Radiation: carbon ion RT; daily carbon ion radiotherapy; Drug: Chemotherapy drug; Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians.
Active Comparator: Routine standard of care; Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs.	Drug: Chemotherapy drug; Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival duration	The length of time from randomization of treatment for cancer, that patients diagnosed with the disease are still alive.	The length of time from randomization until death from any cause for up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival duration	The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.	he length of time from study registration until disease progression at any site or death from any cause, up to 24 months
Local disease progression scored using RECIST 1.1 criteria	A set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment	Up to 24 months
Adverse events as defined by CTCAE v5.0	A set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.	Up to 24 months
Quality-of-life, measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 questionnaire	Questionnaire developed to measure the quality of life of cancer patients. Composite scores range from 0 to 100, with higher scores being more favorable.	up to 24 months

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: Shanghai Proton and Heavy Ion Center
• Investigators: Principal Investigator: Nitin Ohri, MD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): August 24, 2022
• Study Completion (Actual): August 24, 2022

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: pancreatic cancer; carbon ion
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 2020-11511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes