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Clinical Trial Record

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Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

2016-04-01

2019-07-09

2019-07-09

14

Study Overview

Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

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.

N/A

  • Pancreatic Cancer
  • Cancer
  • RADIATION: Carbon Ion
  • DRUG: Gemcitabine + Cisplatin
  • DRUG: Gemcitabine + Capecitabine
  • DRUG: Gemcitabine + Erlotinib
  • DRUG: Gemcitabine
  • RADIATION: Photon
  • 2015-5026
  • 261201500022C-0-0-1 (U.S. NIH Grant/Contract)

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

2016-03-08  

N/A  

2020-04-21  

2018-01-10  

N/A  

2020-04-22  

2018-01-18  

N/A  

2020-04  

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:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Arm 1

Dose-escalation phase I clinical study. In the initial dose levels, 'dose-escalation' refers to an increase in the radiotherapy dose delivered using carbon ion radiotherapy along with a corresponding decrease in the dose delivered using photons.

RADIATION: Carbon Ion

  • Study subjects will receive carbon ion radiotherapy (CIRT), with daily fraction sizes of 3 GyE. The total CIRT dose will increase with each dose level. Subjects in dose level 1 and 2 will receive photon radiotherapy as well.

DRUG: Gemcitabine + Cisplatin

  • Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen. All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locall

DRUG: Gemcitabine + Capecitabine

  • Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen. All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locall

DRUG: Gemcitabine + Erlotinib

  • Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen. All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locall

DRUG: Gemcitabine

  • Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen. All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locall

RADIATION: Photon

  • During this study, the prescribed dose shall be administered according to the dose escalation shown in the table, starting with dose level 1. The carbon ion dose shall be gradually escalated while gradually reducing the dose of photons until eventually ad
Primary Outcome MeasuresMeasure DescriptionTime Frame
Dose-limiting toxicityAny CTCAE v. 4.03 non-hematologic adverse event of grade 3 or higher or any hematologic adverse event of grade 4 or higher, occurring within 90 days of the start of radiotherapy and deemed to be related to carbon ion radiotherapy.90 days
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0through study completion, an average of 1 year
Radiographic changes following completion of study therapy (RECIST v. 1.1)Radiographic changes following completion of study therapy (RECIST v. 1.1)through study completion, an average of 1 year
Overall survival durationThe length of time from study inclusion until death from any causethrough study completion, an average of 1 year
Progression-free survival durationThe length of time from study inclusion until death from any cause or disease progression at any sitethrough study completion, an average of 1 year
The impact in terms of overall quality of life of radiation therapy as assessed by the QLQ-C30 questionnaireQuality of life will be assessed at various time points using the European Organisation for Research and Treatment of Cancer 30 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many cancer related clinical trials.through study completion, an average of 1 year

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:

    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); 11. Adequate liver function: total bilirubin <1.5 x ULN, and AST and ALT <2.5 x ULN; 12. Adequate kidney function: serum creatinine ≤1.25 x ULN or calculated creatinine clearance rate ≥50mL/min and urine protein <2+.If the patient's baseline urine protein is at ≥2+, urine samples must be taken for 24 hours to verify that urine protein is ≤1g; 13. Laboratory studies within 14 days prior to registration demonstrating that the internationalization standard ratio (INR) ≤1.5 and prothrombin time (PPT) ≤1.5 x ULN. 14. Prior receipt of 2-4 cycles of Gemcitabine-based systemic chemotherapy.
    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; 11. Drug-abuse or alcohol dependency; 12. HIV positive, including those that have received antiretroviral therapy; replicative stage of chronic Hepatitis B virus; active stage of Hepatitis C; and active stage of syphilis; 13. HBV positive patients suffering from replicative stage of hepatitis virus, requiring antiretroviral therapy but cannot due to a concomitant disease; 14. Patients with a history of mental illness that may prevent their completion of treatment; 15. Patients with serious complications that could affect the course of treatment, including:

  • Unstable angina, congestive heart failure, or myocardial infarction requiring hospital admittance over the last 6 months;
  • Acute or systemic bacterial infection;
  • Chronic exacerbated obstructive pulmonary disease or other respiratory system disease requiring inpatient treatment;
  • Impaired liver function or impaired kidney function;
  • Patients suffering from immunosuppression; 16. Patients with contraindications to receiving radiotherapy, such as a serious connective tissue disease (eg: scleroderma) 17. Patients that are unable to understand the objective of the treatment/cannot sign the informed consent form; 18. Patients that lack civil capacity to act or whose civil capacity to act is limited.

Collaborators and Investigators

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

  • Shanghai Proton and Heavy Ion Center
  • PRINCIPAL_INVESTIGATOR: Chandan Guha, M.B.B.S., Ph.D., Albert Einstein College of Medicine

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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