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| ID | Type | Description | Link |
|---|---|---|---|
| 261201500022C-0-0-1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Shanghai Proton and Heavy Ion Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon Ion | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0 | 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) |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Chandan Guha, M.B.B.S., Ph.D. | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States | ||
| Shanghai Proton and Heavy Ion Center |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| D000069347 | Erlotinib Hydrochloride |
| D017785 | Photons |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine + Cisplatin | Drug | 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. |
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| Gemcitabine + Capecitabine | Drug | 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. |
|
| Gemcitabine + Erlotinib | Drug | 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. |
|
| Gemcitabine | Drug | 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. |
|
| Photon | Radiation | 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. |
|
Radiographic changes following completion of study therapy (RECIST v. 1.1) |
| through study completion, an average of 1 year |
| Overall survival duration | The length of time from study inclusion until death from any cause | through study completion, an average of 1 year |
| Progression-free survival duration | 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 | 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 |
| Shanghai |
| Shanghai Municipality |
| China |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011840 | Radiation, Nonionizing |