- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03403049
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Shanghai Proton and Heavy Ion Center
-
-
-
-
New York
-
Bronx, New York, United States, 10461
- Albert Einstein College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed the informed consent form;
- Age ≥ 18;
- Capable of following the protocol
- Cytologically or histologically proven diagnosis of adenocarcinoma of the pancreas;
- 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;
- No evidence of distant metastases based on imaging evaluation;
- Maximum tumor and positive lymph node diameter ≤ 6 cm;
- ECOG Performance Status 0-1;
- Life expectancy ≥ 12 weeks;
- 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);
- Adequate liver function: total bilirubin <1.5 x ULN, and AST and ALT <2.5 x ULN;
- 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;
- 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.
- Prior receipt of 2-4 cycles of Gemcitabine-based systemic chemotherapy.
Exclusion Criteria:
- Lack of pathologic confirmation of pancreatic malignancy prior to treatment initiation;
- ECOG Performance Status >=2;
- Poor liver, kidney and bone marrow function that do not meet the requirements for treatment;
- Persistent grade ≥ 2 toxicity due to previous cancer treatment;
- Patient has previously received abdominal radiation therapy or abdominal radioactive seed implantation;
- 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;
- 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.;
- If the doctor determines that the heavy proton or carbon ion dosage radiotherapy will not bring any benefit to the patient;
- Patients suffering from another illness or other factors that could affect the proton or carbon ion therapy;
- Pregnant (verified by serum or urine β-HCG test) or breastfeeding females;
- Drug-abuse or alcohol dependency;
- 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;
- HBV positive patients suffering from replicative stage of hepatitis virus, requiring antiretroviral therapy but cannot due to a concomitant disease;
- Patients with a history of mental illness that may prevent their completion of treatment;
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;
- Patients with contraindications to receiving radiotherapy, such as a serious connective tissue disease (eg: scleroderma)
- Patients that are unable to understand the objective of the treatment/cannot sign the informed consent form;
- Patients that lack civil capacity to act or whose civil capacity to act is limited.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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.
|
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.
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 locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy. 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 locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy. 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 locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy. 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 locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy.
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 administering a full dose of 56 GyE/14 Fx carbon ions (fractional dose of 4 GyE).
Dose escalation will be performed in parallel for two patient groups: patients whose pancreatic tumors are greater than 5 mm from the duodenum (Group A) and those whose tumors are within 5 mm of the duodenum (Group B).
Enrolled patients will be monitored for 90 days after radiotherapy starts for any acute toxic reaction and to explore the maximum tolerated dose, in addition to being observed for any related long-term toxic reactions in accordance with the protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicity
Time Frame: 90 days
|
Any 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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0
Time Frame: through study completion, an average of 1 year
|
Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0
|
through study completion, an average of 1 year
|
Radiographic changes following completion of study therapy (RECIST v. 1.1)
Time Frame: through study completion, an average of 1 year
|
Radiographic changes following completion of study therapy (RECIST v. 1.1)
|
through study completion, an average of 1 year
|
Overall survival duration
Time Frame: through study completion, an average of 1 year
|
The length of time from study inclusion until death from any cause
|
through study completion, an average of 1 year
|
Progression-free survival duration
Time Frame: through study completion, an average of 1 year
|
The length of time from study inclusion until death from any cause or disease progression at any site
|
through 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 questionnaire
Time Frame: through study completion, an average of 1 year
|
Quality 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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chandan Guha, M.B.B.S., Ph.D., Albert Einstein College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protein Kinase Inhibitors
- Gemcitabine
- Erlotinib Hydrochloride
- Capecitabine
Other Study ID Numbers
- 2015-5026
- 261201500022C-0-0-1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Palleon Pharmaceuticals, Inc.RecruitingMelanoma | Cancer | Breast Cancer | Head and Neck Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Ovarian Cancer | NSCLC | Non Small Cell Lung Cancer | Bladder Cancer | Colon Cancer | Urothelial Cancer | Oncology | CRC | Esophagogastric Junction Cancer | EGJUnited States
Clinical Trials on Carbon Ion
-
Shanghai Proton and Heavy Ion CenterRecruitingLocalized Prostate CancerChina
-
University Hospital HeidelbergRecruiting
-
Heidelberg UniversityRecruitingChordoma | Tumor | TreatmentGermany
-
University Hospital HeidelbergActive, not recruiting
-
University Hospital HeidelbergCompletedRecurrent Rectal CancerGermany
-
University Hospital HeidelbergWithdrawnLocally Advanced Pancreatic CancerGermany
-
Shanghai Proton and Heavy Ion CenterRecruiting
-
Shanghai Proton and Heavy Ion CenterRecruitingPancreatic Cancer Non-resectableChina
-
Shanghai Proton and Heavy Ion CenterRecruitingProstate Cancer | RadiotherapyChina
-
Shanghai Proton and Heavy Ion CenterRecruiting