Carbon Ion RT For Locally Advanced Pancreatic Cancer

Study Overview

Carbon Ion RT 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.

N/A

Pancreatic Cancer

RADIATION: carbon ion RT
DRUG: Chemotherapy drug

2020-11511

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-09-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-01-02
First Submitted that Met QC Criteria 2020-10-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-01-05
First Posted (ACTUAL) 2020-10-19	Results First Posted N/A	Last Verified 2024-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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 phys
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 phys

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 phys

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 phys

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

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:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Shanghai Proton and Heavy Ion Center

Investigators

PRINCIPAL_INVESTIGATOR: Nitin Ohri, MD, Associate Professor

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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