Pancreas CancerPhase 1IORTNCT02599662
Intraoperative Radiation Therapy for Resectable Pancreas Cancer
A Phase 1 study testing 10 Gy Low-KV IORT, 15 Gy Low-KV IORT and 20 GY Low-KV IORT in people with Pancreas Cancer, run by Loyola University at 1 site in United States.
Trial summary
Currently, for patients with pancreatic cancer the standard treatment is surgery followed by chemotherapy and/or radiation therapy. An investigational approach is to perform the surgery and treat the area of the tumor with intraoperative radiotherapy in one procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- 10 Gy Low-KV IORT, 15 Gy Low-KV IORT and 20 GY Low-KV IORT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed pancreatic adenocarcinoma.
- Age ≥ 18 years.
- Performance status ECOG 0-1.
- Patient must have resectable disease. In order to be resectable the following criteria must be met:
- Absence of distant metastases.
- Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery .
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- Absence of direct involvement of inferior vena cava or aorta.
- Stage I and stage II disease per AJCC 7th edition.
- Complete history and physical examination including weight and ECOG performance status within 31 days of entry.
- Laboratory data obtained ≤ 14 days prior to registration on study, with adequate bone marrow and organ function defined as follows:
- Laboratory Test Result Leukocytes ≥3000/mm3 Absolute Neutrophil Count (ANC) ≥1500/mm3 Platelets ≥100,000/mm3 Total Bilirubin ≤1.4 mg/dL AST(SGOT),ALT(SPGT) ≤2.5 x institutional upper limit of normal Serum creatinine ≤1.4 mg/dL INR ≤1.5 BUN < 20 mg/dL Albumin ≥3.5 g/dL
- Negative serum pregnancy test for females of childbearing potential within 14 days of study registration. Should a female participant become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months.
- Abdominal CT scan with contrast prior to performance of surgery. If patient is allergic to contrast an abdominal MRI may substitute. Other imaging may be added or substituted as deemed appropriate by the treatment team (surgeon, radiation oncologist, medical oncologist).
- Ability to understand and the willingness to sign a written informed consent.
- Signed study specific informed consent.
- Patients with prior history of malignancy are permitted to register in the study as long as they are not actively taking cytotoxic or biologic medication for treatment of the prior malignancy. Patient must be disease-free from any malignancy for at least the previous 6 months and must have no history of brain metastases.
- Consultation, agreement, and documentation by a radiation oncologist that the patient is suitable to receive radiotherapy per this protocol.
- Consultation, agreement, and documentation by surgeon that the patient is a suitable surgical candidate.
- Consultation, agreement, and documentation by an anesthesiologist that patient is suitable to receive general anesthesia.
Who cannot join
- Defined treatment area which cannot be adequately covered by the radiation field as defined by the radiation oncology treatment team.
- Patients who have received neoadjuvant chemotherapy are ineligible.
- Patients with Stage III-Stage IV disease.
- Patients who have been on an immunosuppressive agent (excluding corticosteroids) within 4 weeks of the proposed operation.
- Patients receiving any other investigational agents.
- Current pregnancy or currently nursing.
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- History of brain metastases.
- Severe, active comorbidity defined as follows
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months. [23]
- Myocardial infarction within 3 months of study registration [23].
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
- Chronic Obstructive Pulmonary Disease or other respiratory illness hospitalization or precluding study therapy at time of registration [23].
- Uncontrolled diabetes which in the opinion of any of the patient's physicians requires an immediate change in management. A patient may be considered eligible if the patient's physician managing the diabetes deems the appropriate changes in management have resulted in adequate control. [23].
- BMI >30.
- Patient with active diagnosis of a bleeding disorder. [23]
- Patients enrolled in another interventional clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Beth Chiappetta, BSN, 708-216-2568, bchiappetta@lumc.edu
Tarita Thomas, MD,PhD, 708-216- 2571, tathomas@lumc.edu
About this study
Official title: Phase I Study of Low Kilovoltage Intraoperative Radiation for Patients With Resectable Pancreatic Adenocarcinoma
Currently, for patients with pancreatic cancer the standard treatment is surgery followed by chemotherapy and/or radiation therapy. An investigational approach is to perform the surgery and treat the area of the tumor with intraoperative radiotherapy in one procedure. Intraoperative radiation delivers low energy x-rays to a targeted area during the time of tumor removal.
The purpose of this study is to learn about both the good and bad effects of adding intraoperative radiation therapy. Another goal is to determine and compare the quality of life before and after the procedure. We will also monitor the effect of the therapy on the cancer lesion and any complications that may result.
Read the detailed description
The purpose of this study is to determine safety of low kilovoltage radiotherapy delivery of a focused dose of radiation to the areas at high risk for locoregional recurrence following pancreaticoduodenectomy. This surgery is currently the only potentially curative approach for patients with pancreatic cancer. Unfortunately, following surgery alone >50% of patients will have a local recurrence of disease [5]. Local control will become increasingly important as chemotherapy regimens continue to improve the distant metastases-free survival. Intraoperative radiation therapy allows direct access to the tumor bed and areas of concern while allowing displacement and shielding of normal tissue and organs at risk of radiation toxicity.
Study Objectives The primary objective is to determine the maximum tolerated dose (MTD) for low kilovoltage (kV) intraoperative radiotherapy (IORT)
The secondary objectives are:
To develop acute and chronic toxicity profiles for this treatment modality
To determine the feasibility of including low-kV IORT in the treatment of pancreatic cancer
To evaluate the following physics and delivery parameters: treatment prescription dose, depth of treatment, applicator type, and treatment time.
To measure patient's quality of life (QOL) before and after treatment, including change in pain level and fatigue level.
To describe the disease specific outcomes of local regional control, progression free-survival, distant metastasis free-survival, disease free-survival and overall survival associated with low-kV IORT following pancreaticoduodenectomy.
- Conditions
- Pancreas Cancer
- Being tested
- 10 Gy Low-KV IORT, 15 Gy Low-KV IORT, 20 GY Low-KV IORT
- Keywords
- Cancer, Intraoperative Radiation Therapy - IORT
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 Gy Low-KV IORTRadiation
: intraoperative low-kV IORT will be delivered as a single dose of 10 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.
15 Gy Low-KV IORTRadiation
intraoperative low-kV IORT will be delivered as a single dose of 15 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.
20 GY Low-KV IORTRadiation
intraoperative low-kV IORT will be delivered as a single dose of 20 Gy at 2 millimeter depth. Patients will be accrued to this group until the DLT is reached and MTD is realized.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 10 Gy Low-KV IORT | Other | 10 Gy Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 10 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized. Receives: Radiation: 10 Gy Low-KV IORT |
| Group 2: 15 Gy Low-KV IORT | Other | 15 Gy Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 15 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized. Receives: Radiation: 15 Gy Low-KV IORT |
| Group 3: 20 GY Low-KV IORT | Other | 20 GY Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 20 Gy at 2 millimeter depth. Patients will be accrued to this group until the DLT is reached and MTD is realized. Receives: Radiation: 20 GY Low-KV IORT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Maximum Tolerated Dose as defined by Radiation-related acute Grade 3-5 toxicity in greater than or equal to 2 patients out of 6 patients at any dose level
Measured: 52 weeks
Secondary outcomes (1)
QOL surveys
. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQC30) 30 item questionnaire to evaluate cancer patients' physical, psychological, and social functioning. Patients are asked to rate symptoms on a YES or NO scale; a 4 point scale ranging from 1 (Not at all) to 4 (Very much); and a 7 point scale ranging 1 (Very poor) to 7 (Excellent)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarita Thomas, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599662
- Sponsor's protocol ID
- 207194
- Other IDs
- 20719412115
- Acronym
- IORT
- Status last verified
- Jun 2020
- First submitted
- 5 Nov 2015
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
PubMed 23335087Kalser MH, Ellenberg SS. Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg. 1985 Aug;120(8):899-903. doi: 10.1001/archsurg.1985.01390320023003.
PubMed 4015380Mohammed S, Van Buren G 2nd, Fisher WE. Pancreatic cancer: advances in treatment. World J Gastroenterol. 2014 Jul 28;20(28):9354-60. doi: 10.3748/wjg.v20.i28.9354.
PubMed 25071330Nagakawa T, Kayahara M, Ohta T, Ueno K, Konishi I, Miyazaki I. Patterns of neural and plexus invasion of human pancreatic cancer and experimental cancer. Int J Pancreatol. 1991 Oct;10(2):113-9. doi: 10.1007/BF02924114.
PubMed 1660909Gnerlich JL, Luka SR, Deshpande AD, Dubray BJ, Weir JS, Carpenter DH, Brunt EM, Strasberg SM, Hawkins WG, Linehan DC. Microscopic margins and patterns of treatment failure in resected pancreatic adenocarcinoma. Arch Surg. 2012 Aug;147(8):753-60. doi: 10.1001/archsurg.2012.1126.
PubMed 22911074Iqbal N, Lovegrove RE, Tilney HS, Abraham AT, Bhattacharya S, Tekkis PP, Kocher HM. A comparison of pancreaticoduodenectomy with extended pancreaticoduodenectomy: a meta-analysis of 1909 patients. Eur J Surg Oncol. 2009 Jan;35(1):79-86. doi: 10.1016/j.ejso.2008.01.002. Epub 2008 Mar 19.
PubMed 18356005Hiraoka T. Extended radical resection of cancer of the pancreas with intraoperative radiotherapy. Baillieres Clin Gastroenterol. 1990 Dec;4(4):985-93. doi: 10.1016/0950-3528(90)90031-b. No abstract available.
PubMed 2078795Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
PubMed 21561347Wood WC, Shipley WU, Gunderson LL, Cohen AM, Nardi GL. Intraoperative irradiation for unresectable pancreatic carcinoma. Cancer. 1982 Mar 15;49(6):1272-5. doi: 10.1002/1097-0142(19820315)49:63.0.co;2-e.
PubMed 6800633Shipley WU, Wood WC, Tepper JE, Warshaw AL, Orlow EL, Kaufman SD, Battit GE, Nardi GL. Intraoperative electron beam irradiation for patients with unresectable pancreatic carcinoma. Ann Surg. 1984 Sep;200(3):289-96. doi: 10.1097/00000658-198409000-00006.
PubMed 6205632Kawai M, Yamaue H. Analysis of clinical trials evaluating complications after pancreaticoduodenectomy: a new era of pancreatic surgery. Surg Today. 2010 Nov;40(11):1011-7. doi: 10.1007/s00595-009-4245-9. Epub 2010 Nov 3.
PubMed 21046497Parikh P, Shiloach M, Cohen ME, Bilimoria KY, Ko CY, Hall BL, Pitt HA. Pancreatectomy risk calculator: an ACS-NSQIP resource. HPB (Oxford). 2010 Sep;12(7):488-97. doi: 10.1111/j.1477-2574.2010.00216.x.
PubMed 20815858Lermite E, Sommacale D, Piardi T, Arnaud JP, Sauvanet A, Dejong CH, Pessaux P. Complications after pancreatic resection: diagnosis, prevention and management. Clin Res Hepatol Gastroenterol. 2013 Jun;37(3):230-9. doi: 10.1016/j.clinre.2013.01.003. Epub 2013 Feb 14.
PubMed 23415988
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Low Kilovoltage Intraoperative Radiation for Patients With Resectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02599662
- Acronym / sponsor ID
- IORT / 207194
- Conditions
- Pancreas Cancer
- Keywords
- Cancer, Intraoperative Radiation Therapy - IORT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, for patients with pancreatic cancer the standard treatment is surgery followed by chemotherapy and/or radiation therapy. An investigational approach is to perform the surgery and treat the area of the tumor with intraoperative radiotherapy in one procedure. Intraoperative radiation delivers low energy x-rays to a targeted area during the time of tumor removal.
The purpose of this study is to learn about both the good and bad effects of adding intraoperative radiation therapy. Another goal is to determine and compare the quality of life before and after the procedure. We will also monitor the effect of the therapy on the cancer lesion and any complications that may result.
Detailed description
The purpose of this study is to determine safety of low kilovoltage radiotherapy delivery of a focused dose of radiation to the areas at high risk for locoregional recurrence following pancreaticoduodenectomy. This surgery is currently the only potentially curative approach for patients with pancreatic cancer. Unfortunately, following surgery alone >50% of patients will have a local recurrence of disease [5]. Local control will become increasingly important as chemotherapy regimens continue to improve the distant metastases-free survival. Intraoperative radiation therapy allows direct access to the tumor bed and areas of concern while allowing displacement and shielding of normal tissue and organs at risk of radiation toxicity.
Study Objectives The primary objective is to determine the maximum tolerated dose (MTD) for low kilovoltage (kV) intraoperative radiotherapy (IORT)
The secondary objectives are:
To develop acute and chronic toxicity profiles for this treatment modality
To determine the feasibility of including low-kV IORT in the treatment of pancreatic cancer
To evaluate the following physics and delivery parameters: treatment prescription dose, depth of treatment, applicator type, and treatment time.
To measure patient's quality of life (QOL) before and after treatment, including change in pain level and fatigue level.
To describe the disease specific outcomes of local regional control, progression free-survival, distant metastasis free-survival, disease free-survival and overall survival associated with low-kV IORT following pancreaticoduodenectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: 10 Gy Low-KV IORT | Other | Radiation: 10 Gy Low-KV IORT10 Gy Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 10 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized. |
| Group 2: 15 Gy Low-KV IORT | Other | Radiation: 15 Gy Low-KV IORT15 Gy Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 15 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized. |
| Group 3: 20 GY Low-KV IORT | Other | Radiation: 20 GY Low-KV IORT20 GY Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 20 Gy at 2 millimeter depth. Patients will be accrued to this group until the DLT is reached and MTD is realized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Pathologically confirmed pancreatic adenocarcinoma.
- Age ≥ 18 years.
- Performance status ECOG 0-1.
- Patient must have resectable disease. In order to be resectable the following criteria must be met:
- Absence of distant metastases.
Key exclusion criteria (16 listed)
- Defined treatment area which cannot be adequately covered by the radiation field as defined by the radiation oncology treatment team.
- Patients who have received neoadjuvant chemotherapy are ineligible.
- Patients with Stage III-Stage IV disease.
- Patients who have been on an immunosuppressive agent (excluding corticosteroids) within 4 weeks of the proposed operation.
- Patients receiving any other investigational agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 Gy Low-KV IORT: intraoperative low-kV IORT will be delivered as a single dose of 10 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized. | Radiation | Group 1: 10 Gy Low-KV IORT |
| 15 Gy Low-KV IORTintraoperative low-kV IORT will be delivered as a single dose of 15 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized. | Radiation | Group 2: 15 Gy Low-KV IORT |
| 20 GY Low-KV IORTintraoperative low-kV IORT will be delivered as a single dose of 20 Gy at 2 millimeter depth. Patients will be accrued to this group until the DLT is reached and MTD is realized. | Radiation | Group 3: 20 GY Low-KV IORT |
Primary outcome
Maximum Tolerated Dose
Time frame: 52 weeks
Maximum Tolerated Dose as defined by Radiation-related acute Grade 3-5 toxicity in greater than or equal to 2 patients out of 6 patients at any dose level
1 secondary outcome
QOL surveys
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 23335087Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
- Background: PubMed 4015380Kalser MH, Ellenberg SS. Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg. 1985 Aug;120(8):899-903. doi: 10.1001/archsurg.1985.01390320023003.
- Background: PubMed 25071330Mohammed S, Van Buren G 2nd, Fisher WE. Pancreatic cancer: advances in treatment. World J Gastroenterol. 2014 Jul 28;20(28):9354-60. doi: 10.3748/wjg.v20.i28.9354.
- Background: PubMed 1660909Nagakawa T, Kayahara M, Ohta T, Ueno K, Konishi I, Miyazaki I. Patterns of neural and plexus invasion of human pancreatic cancer and experimental cancer. Int J Pancreatol. 1991 Oct;10(2):113-9. doi: 10.1007/BF02924114.
- Background: PubMed 22911074Gnerlich JL, Luka SR, Deshpande AD, Dubray BJ, Weir JS, Carpenter DH, Brunt EM, Strasberg SM, Hawkins WG, Linehan DC. Microscopic margins and patterns of treatment failure in resected pancreatic adenocarcinoma. Arch Surg. 2012 Aug;147(8):753-60. doi: 10.1001/archsurg.2012.1126.
- Background: PubMed 18356005Iqbal N, Lovegrove RE, Tilney HS, Abraham AT, Bhattacharya S, Tekkis PP, Kocher HM. A comparison of pancreaticoduodenectomy with extended pancreaticoduodenectomy: a meta-analysis of 1909 patients. Eur J Surg Oncol. 2009 Jan;35(1):79-86. doi: 10.1016/j.ejso.2008.01.002. Epub 2008 Mar 19.
- Background: PubMed 2078795Hiraoka T. Extended radical resection of cancer of the pancreas with intraoperative radiotherapy. Baillieres Clin Gastroenterol. 1990 Dec;4(4):985-93. doi: 10.1016/0950-3528(90)90031-b. No abstract available.
- Background: PubMed 21561347Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
- Background: PubMed 6800633Wood WC, Shipley WU, Gunderson LL, Cohen AM, Nardi GL. Intraoperative irradiation for unresectable pancreatic carcinoma. Cancer. 1982 Mar 15;49(6):1272-5. doi: 10.1002/1097-0142(19820315)49:63.0.co;2-e.
- Background: PubMed 6205632Shipley WU, Wood WC, Tepper JE, Warshaw AL, Orlow EL, Kaufman SD, Battit GE, Nardi GL. Intraoperative electron beam irradiation for patients with unresectable pancreatic carcinoma. Ann Surg. 1984 Sep;200(3):289-96. doi: 10.1097/00000658-198409000-00006.
- Background: PubMed 21046497Kawai M, Yamaue H. Analysis of clinical trials evaluating complications after pancreaticoduodenectomy: a new era of pancreatic surgery. Surg Today. 2010 Nov;40(11):1011-7. doi: 10.1007/s00595-009-4245-9. Epub 2010 Nov 3.
- Background: PubMed 20815858Parikh P, Shiloach M, Cohen ME, Bilimoria KY, Ko CY, Hall BL, Pitt HA. Pancreatectomy risk calculator: an ACS-NSQIP resource. HPB (Oxford). 2010 Sep;12(7):488-97. doi: 10.1111/j.1477-2574.2010.00216.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 10 Gy Low-KV IORT, 15 Gy Low-KV IORT and 20 GY Low-KV IORT in people with Pancreas Cancer, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beth Chiappetta, BSN (708-216-2568, bchiappetta@lumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02599662, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.