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Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

A Prospective Phase I Clinical Trial of Carbon Ion Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer

NCT03403049•Albert Einstein College of Medicine

View on ClinicalTrials.gov

Summary

This is a phase I trial to determine the maximum tolerated dose of carbon ion radiotherapy for the treatment of locally advanced, unresectable, pancreatic cancer.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed the informed consent form;
•2. Age ≥ 18;
•3. Capable of following the protocol
•4. Cytologically or histologically proven diagnosis of adenocarcinoma of the pancreas;
•5. Unresectable adenocarcinoma of the pancreas by radiographic criteria according to the criteria of the NCCN Guidelines and based on post-chemotherapy imaging or due to medical contraindications to radical resection;
•6. No evidence of distant metastases based on imaging evaluation;
•7. Maximum tumor and positive lymph node diameter ≤ 6 cm;
•8. ECOG Performance Status 0-1;
•9. Life expectancy ≥ 12 weeks;
•10. Adequate blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥100 x 109/L, and hemoglobin ≥9 g/dL (use of transfusion to achieve said levels or greater is acceptable);
+4 more criteria

Exclusion Criteria

•1. Lack of pathologic confirmation of pancreatic malignancy prior to treatment initiation;
•2. ECOG Performance Status \>=2;
•3. Poor liver, kidney and bone marrow function that do not meet the requirements for treatment;
•4. Persistent grade ≥ 2 toxicity due to previous cancer treatment;
•5. Patient has previously received abdominal radiation therapy or abdominal radioactive seed implantation;
•6. Those wearing a cardiac pacemaker or another type of metal prosthetic implant whose normal functions may suffer interference from high energy radiation or that could affect the radiation target area;
•7. Where it is not possible to achieve the predetermined safety dose limit with the dose equivalent limit of the organ at risk such as the liver or digestive tract, etc.;
•8. If the doctor determines that the heavy proton or carbon ion dosage radiotherapy will not bring any benefit to the patient;
•9. Patients suffering from another illness or other factors that could affect the proton or carbon ion therapy;
•10. Pregnant (verified by serum or urine β-HCG test) or breastfeeding females;
+13 more criteria

Locations (2)

Albert Einstein College of Medicine

The Bronx, New York, United States

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 1, 2016

Primary Completion Date

July 9, 2019

Completion Date

July 9, 2019

Last Updated

April 22, 2020

Enrollment

ACTUAL participants

Conditions

Pancreatic CancerCancer

Interventions

Carbon Ion

RADIATION

Gemcitabine + Cisplatin

DRUG

Gemcitabine + Capecitabine

DRUG

Gemcitabine + Erlotinib

DRUG

Gemcitabine

DRUG

Photon

RADIATION

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

NCT06980038

Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell Carcinoma+20 more

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RECRUITINGPHASE2

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

NCT03375307

Advanced Bladder CarcinomaAdvanced Genitourinary System Carcinoma+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Early Detection of Liver Cancer by QUS

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device