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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| National Cancer Institute (NCI) | NIH |
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A standard treatment for pancreatic cancer is radiation therapy plus chemotherapy after surgery. Radiation therapy and chemotherapy are commonly given for up to six weeks. Previous research has suggested that giving the radiation and chemotherapy for a shorter amount of time (accelerated schedule) before surgery may be better tolerated. In this research study, different schedules of proton radiation therapy will be used. Each schedule will give about the same total dose of radiation. However, the total dose will be spread out over different time periods and different numbers of sessions. The purpose is to find the shortest schedule of radiation therapy that can be given without unacceptable side effects. Proton beam radiation is being used because of its unique ability to deposit its energy directly in the tumor, resulting in less radiation to normal tissue. A new type of PET scan is also being studied to see if it can help predict the response to pre-surgery treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 10 Radiation Sessions over 2 weeks |
|
| Group 2 | Experimental | 5 Radiation sessions: 3 in week 1 and 2 in week 2 |
|
| Group 3 | Experimental | 5 Radiation sessions: 4 in week 1 and 1 in week 2 |
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| Group 4 | Experimental | 5 Radiation Sessions in one week |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Beam Radiation | Procedure | Given over different schedules and duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm | The number of participants that experienced a dose limiting toxicity in the arm where radiation was administered over 5 consecutive for a total dose of 25 Gray Equivalents (GyE) (Group 4). Participants were monitored for potential Dose Limiting Toxicities (DLT) for three weeks after the start of radiation. DLTs included:
| 3 Weeks |
| Number of Participants With Grade 3 or Greater Toxicity in Phase II | Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). The regimen was considered to be tolerated if less than 20% of participants experienced a grade 3 or greater toxicity. | 30 days after the end of treatment, up to approximately 6 months total |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Pathological Complete Response | All patients that received surgery underwent a full pathological review of their pancreaticoduodenectomy specimen according to the American Joint Committee on Cancer (AJCC) Staging Classification, 6th. Initial gross evaluation and identification of resection margins was performed jointly by the surgeon and the pathologist. Pathological complete response will be defined as the absence of any viable tumor cells within the pathologic specimen. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodore Hong, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24867540 | Derived | Hong TS, Ryan DP, Borger DR, Blaszkowsky LS, Yeap BY, Ancukiewicz M, Deshpande V, Shinagare S, Wo JY, Boucher Y, Wadlow RC, Kwak EL, Allen JN, Clark JW, Zhu AX, Ferrone CR, Mamon HJ, Adams J, Winrich B, Grillo T, Jain RK, DeLaney TF, Fernandez-del Castillo C, Duda DG. A phase 1/2 and biomarker study of preoperative short course chemoradiation with proton beam therapy and capecitabine followed by early surgery for resectable pancreatic ductal adenocarcinoma. Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):830-8. doi: 10.1016/j.ijrobp.2014.03.034. Epub 2014 May 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Beam Radiation/ Capecitabine Dose Level 1 | Procedure/Surgery: Proton Beam Radiation: Given over 10 Radiation Sessions over 2 weeks Drug: Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks |
| FG001 | Proton Beam Radiation/ Capecitabine Dose Level 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2010 |
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| Capecitabine | Drug | Given orally starting on day one of radiation therapy for 2 weeks |
|
| at the time of surgery (28-42 days after start of treatment) |
| Median Progression Free Survival | The median amount of time from the start of treatment until death or disease progression, whichever occurs first. Progressive Disease (PD): A 20% or greater increase in the sum of Longest Diameter (LD) of all target lesions, taking as reference the smallest sum LD recorded since baseline. | from the start of treatment until death or progression, median duration of 10.4 months |
| Number of Participants With Surgical Morbidity | Number of participants with pancreatic or any other anastomotic leakage within 30 days of surgery | 30 days post surgery (surgery was 28-42 days after the start of treatment) |
| 30-Day Post Operative Mortality | The number of participants that died within 30 days of undergoing a pancreaticoduodenectomy. | 30 days after the time of surgery (Surgery is 28-42 days after start of treatment) |
| Number of Participants With Treatment Related Serious Adverse Events | The number of participants that had treatment related serious adverse events. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). Adverse events were considered to be serious adverse events if they were grade 3 or greater and were considered to be possibly, probably, or definitely related to treatment. | From the start of treatment until 30 days after the end of treatment, up to approximately 5 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
Procedure/Surgery: Proton Beam Radiation: Given over 5 Radiation sessions: 3 in week 1 and 2 in week 2 Drug: Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks |
| FG002 | Proton Beam Radiation/ Capecitabine Dose Level 3 | Procedure/Surgery: Proton Beam Radiation: Given over 5 Radiation sessions: 4 in week 1 and 1 in week 2 Drug: Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks |
| FG003 | Proton Beam Radiation/ Capecitabine Dose Level 4 | Procedure/Surgery: Proton Beam Radiation: Given over 5 Radiation Sessions in one week Drug: Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks |
| Surgical Resection |
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| COMPLETED |
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| NOT COMPLETED |
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Phase 1 radiation schedule escalation arms were combined with the phase II dose arm to highlight overall trends of the regimen
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Beam Radiation/ Capecitabine | Procedure/Surgery: Proton Beam Radiation: Given over different schedules and duration Drug: Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| CA19-9 level at baseline | Carbohydrate antigen (CA) 19-9 is an antigen released by pancreatic cancer cells. | Median | Full Range | units per milliliter |
| ||||||||||||||||
| Tumor size on CT | Median | Full Range | Centimeters |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm | The number of participants that experienced a dose limiting toxicity in the arm where radiation was administered over 5 consecutive for a total dose of 25 Gray Equivalents (GyE) (Group 4). Participants were monitored for potential Dose Limiting Toxicities (DLT) for three weeks after the start of radiation. DLTs included:
| The participants treated with radiation therapy at the 5 fractions over 5 consecutive days | Posted | Count of Participants | Participants | 3 Weeks |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Grade 3 or Greater Toxicity in Phase II | Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). The regimen was considered to be tolerated if less than 20% of participants experienced a grade 3 or greater toxicity. | Participants in the Phase II portion of the trial | Posted | Count of Participants | Participants | 30 days after the end of treatment, up to approximately 6 months total |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With a Pathological Complete Response | All patients that received surgery underwent a full pathological review of their pancreaticoduodenectomy specimen according to the American Joint Committee on Cancer (AJCC) Staging Classification, 6th. Initial gross evaluation and identification of resection margins was performed jointly by the surgeon and the pathologist. Pathological complete response will be defined as the absence of any viable tumor cells within the pathologic specimen. | The eligible participants who underwent surgical resection. The phase I arms and Phase II group were combined together for analysis. | Posted | Count of Participants | Participants | at the time of surgery (28-42 days after start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Median Progression Free Survival | The median amount of time from the start of treatment until death or disease progression, whichever occurs first. Progressive Disease (PD): A 20% or greater increase in the sum of Longest Diameter (LD) of all target lesions, taking as reference the smallest sum LD recorded since baseline. | Two participants were excluded from the analysis because of ineligible final diagnoses (cholangiocarcinoma and autoimmune pancreatitis) | Posted | Median | 95% Confidence Interval | Months | from the start of treatment until death or progression, median duration of 10.4 months |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Surgical Morbidity | Number of participants with pancreatic or any other anastomotic leakage within 30 days of surgery | The eligible participants who underwent surgical resections. The phase I arms and Phase II group were combined together for analysis. | Posted | Count of Participants | Participants | 30 days post surgery (surgery was 28-42 days after the start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | 30-Day Post Operative Mortality | The number of participants that died within 30 days of undergoing a pancreaticoduodenectomy. | The eligible participants who underwent surgical resection. The phase I arms and Phase II group were combined together for analysis. | Posted | Count of Participants | Participants | 30 days after the time of surgery (Surgery is 28-42 days after start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Related Serious Adverse Events | The number of participants that had treatment related serious adverse events. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). Adverse events were considered to be serious adverse events if they were grade 3 or greater and were considered to be possibly, probably, or definitely related to treatment. | Posted | Count of Participants | Participants | From the start of treatment until 30 days after the end of treatment, up to approximately 5 months |
|
From the start of treatment until 30 days after the end of treatment, up to approximately approximately 5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proton Beam Radiation/ Capecitabine Dose Level 1 | Procedure/Surgery: Proton Beam Radiation: Given over 10 Radiation Sessions over 2 weeks Drug: Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Proton Beam Radiation/ Capecitabine Dose Level 2 | Procedure/Surgery: Proton Beam Radiation: Given over 5 Radiation sessions: 3 in week 1 and 2 in week 2 Drug: Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Proton Beam Radiation/ Capecitabine Dose Level 3 | Procedure/Surgery: Proton Beam Radiation: Given over 5 Radiation sessions: 4 in week 1 and 1 in week 2 Drug: Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Proton Beam Radiation/ Capecitabine Dose Level 4 | Procedure/Surgery: Proton Beam Radiation: Given over 5 Radiation Sessions in one week Drug: Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks | 0 | 41 | 2 | 41 | 41 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Chest Wall | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdomen- pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ALT- SGPT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST- SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Back- pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-limb- pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Fever w/o neutropenia | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theodore Hong, MD | Massachusetts General Hospital | 617-724-1159 | TSHONG1@mgh.harvard.edu |
| Oct 10, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| OG003 | Proton Beam Radiation/ Capecitabine Dose Level 4 | Procedure/Surgery: Proton Beam Radiation: Given over 5 Radiation Sessions in one week Drug: Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks |
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