Pancreatic CancerORCHESTRATENCT02416609
Low-dose Radiotherapy Plus Chemotherapy With Gem-based Doublets and Stereotactic Radiotherapy for Advanced Pancreatic Cancer
A study testing LDR, Gem-based doublets and SBRT in people with Pancreatic Cancer, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of a chemotherapy regimen with Gem-based doublets administered sequentially with stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined treatment on patients affected by locally advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- LDR, Gem-based doublets and SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Nov 2024
- Phase
- Interventional
- 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 adenocarcinoma of the pancreas
- Patients with unresectable disease based on institutional standardized criteria of unresectability or patients whose disease appeared potentially resectable on axial CT imaging but were found unresectable at surgery
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Age ≥ 18
- Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting treatment
- Patients with radiographically assessable disease
- Adequate bone marrow, hepatic and renal function: -Hemoglobin >10.0 g/dL, absolute neutrophil count > 1.5 x 10^9/L, platelet count > 100 x 10^9/L. -Aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) should be ≤ 3 x upper limit of normal (ULN). -Total bilirubin < 2 mg/dL. Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should decrease to < 2 mg/dL prior to study entry. - Creatinine < 3 mg/dL or Creatinine clearance > 40 mL/min (calculated according to Cockroft and Gault)
Who cannot join
- Evidence of metastatic disease in the major viscera or peritoneal seeding or ascites
- Gastric or duodenal obstruction
- Previous peripheral neuropathy
- Previous irradiation to the planned field; previous chemotherapy for pancreatic cancer
- Malignancy (within the past two years) except non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, MO, 41121
Bruno Meduri, MD, +393388878319, brunomeduri@gmail.com
Bruno Meduri, MD
About this study
Official title: Low-dose Radiotherapy as a Chemo-potentiator of a Induction Chemotherapy Regimen With Gem-based Doublets and Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of a chemotherapy regimen with Gem-based doublets administered sequentially with stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).
- Conditions
- Pancreatic Cancer
- Being tested
- LDR, Gem-based doublets, SBRT
- Keywords
- Locally advanced pancreatic cancer, Stereotactic Body Radiotherapy, Chemopotentiator, Low dose radiotherapy, Hyper-Radiosensitivity
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDRRadiation
Also called Low dose radiotherapy
LDR will be delivered during each cycle of Gem-based doublets
Gem-based doubletsDrug
4 cycles of Gem-based doublets
SBRTRadiation
Also called Steretactic body radiotherapy
SBRT will be administered after the fourth Gem-based doblet cycle, if no progression; three fractions will be administered
| Study group | Role | What they receive |
|---|---|---|
| Gem-based doublets with LDR & sequential SBRT | Experimental | Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered. Receives: Radiation: LDR; Drug: Gem-based doublets; Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
defined as the time from the initiation of therapy to the time of first event (local, regional or distant progression or death due to any cause). Patients without any such event at the time of data analysis will be censored at the last date they were known to be event-free. Patients with no tumor assessments after baseline will be censored at day 1
Measured: 1 year
Secondary outcomes (2)
Toxicity(scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0))
Acute gastrointestinal toxicity is defined as adverse events occurring <3 months after SBRT; long-term toxicity was defined as those occurring after 3 months. Toxicity is scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0)
Measured: every 3 months, up to 1 year
Overall survival
defined as the time from the date of initiation of therapy to date of death due to any cause. Patients who is alive on the date of last follow-up were censored on that date
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionNov 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Meduri, Azienda Ospedaliero-Universitaria di Modena
- Investigators
- Bruno Meduri, MD, Principal investigator, Azienda Ospedaliero-Universitaria Policlinico di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416609
- Sponsor's protocol ID
- BMed1
- Acronym
- ORCHESTRATE
- Status last verified
- Dec 2022
- First submitted
- 7 Apr 2015
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Mantini G, Valentini V, Meduri B, Margaritora S, Balducci M, Micciche F, Nardone L, De Rose F, Cesario A, Larici AR, Maggi F, Calcagni ML, Granone P. Low-dose radiotherapy as a chemo-potentiator of a chemotherapy regimen with pemetrexed for recurrent non-small-cell lung cancer: a prospective phase II study. Radiother Oncol. 2012 Nov;105(2):161-6. doi: 10.1016/j.radonc.2012.09.006. Epub 2012 Oct 12.
PubMed 23068709Regine WF, Hanna N, Garofalo MC, Doyle A, Arnold S, Kataria R, Sims J, Tan M, Mohiuddin M. Low-dose radiotherapy as a chemopotentiator of gemcitabine in tumors of the pancreas or small bowel: a phase I study exploring a new treatment paradigm. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):172-7. doi: 10.1016/j.ijrobp.2006.11.045. Epub 2007 Feb 2.
PubMed 17276612Mahadevan A, Jain S, Goldstein M, Miksad R, Pleskow D, Sawhney M, Brennan D, Callery M, Vollmer C. Stereotactic body radiotherapy and gemcitabine for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):735-42. doi: 10.1016/j.ijrobp.2009.08.046. Epub 2010 Feb 18.
PubMed 20171803Valentini V, Massaccesi M, Balducci M, Mantini G, Micciche F, Mattiucci GC, Dinapoli N, Meduri B, D'Agostino GR, Salvi G, Nardone L. Low-dose hyperradiosensitivity: is there a place for future investigation in clinical settings? Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):535-9. doi: 10.1016/j.ijrobp.2009.02.075. Epub 2009 Jun 18.
PubMed 19540061
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Radiotherapy as a Chemo-potentiator of a Induction Chemotherapy Regimen With Gem-based Doublets and Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02416609
- Acronym / sponsor ID
- ORCHESTRATE / BMed1
- Conditions
- Pancreatic Cancer
- Keywords
- Locally advanced pancreatic cancer, Stereotactic Body Radiotherapy, Chemopotentiator, Low dose radiotherapy, Hyper-Radiosensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 15 Apr 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.
Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of a chemotherapy regimen with Gem-based doublets administered sequentially with stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gem-based doublets with LDR & sequential SBRT | Experimental | Radiation: LDR, Drug: Gem-based doublets, Radiation: SBRTFour Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed adenocarcinoma of the pancreas
- Patients with unresectable disease based on institutional standardized criteria of unresectability or patients whose disease appeared potentially resectable on axial CT imaging but were found unresectable at surgery
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Age ≥ 18
- Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting treatment
- Patients with radiographically assessable disease
Key exclusion criteria (5 listed)
- Evidence of metastatic disease in the major viscera or peritoneal seeding or ascites
- Gastric or duodenal obstruction
- Previous peripheral neuropathy
- Previous irradiation to the planned field; previous chemotherapy for pancreatic cancer
- Malignancy (within the past two years) except non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder
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 |
|---|---|---|
| LDRAlso: Low dose radiotherapyLDR will be delivered during each cycle of Gem-based doublets | Radiation | Gem-based doublets with LDR & sequential SBRT |
| Gem-based doublets4 cycles of Gem-based doublets | Drug | Gem-based doublets with LDR & sequential SBRT |
| SBRTAlso: Steretactic body radiotherapySBRT will be administered after the fourth Gem-based doblet cycle, if no progression; three fractions will be administered | Radiation | Gem-based doublets with LDR & sequential SBRT |
Primary outcome
Progression-free survival
Time frame: 1 year
defined as the time from the initiation of therapy to the time of first event (local, regional or distant progression or death due to any cause). Patients without any such event at the time of data analysis will be censored at the last date they were known to be event-free. Patients with no tumor assessments after baseline will be censored at day 1
2 secondary outcomes
Toxicity(scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0))
Time frame: every 3 months, up to 1 year
Overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Background: PubMed 23068709Mantini G, Valentini V, Meduri B, Margaritora S, Balducci M, Micciche F, Nardone L, De Rose F, Cesario A, Larici AR, Maggi F, Calcagni ML, Granone P. Low-dose radiotherapy as a chemo-potentiator of a chemotherapy regimen with pemetrexed for recurrent non-small-cell lung cancer: a prospective phase II study. Radiother Oncol. 2012 Nov;105(2):161-6. doi: 10.1016/j.radonc.2012.09.006. Epub 2012 Oct 12.
- Background: PubMed 17276612Regine WF, Hanna N, Garofalo MC, Doyle A, Arnold S, Kataria R, Sims J, Tan M, Mohiuddin M. Low-dose radiotherapy as a chemopotentiator of gemcitabine in tumors of the pancreas or small bowel: a phase I study exploring a new treatment paradigm. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):172-7. doi: 10.1016/j.ijrobp.2006.11.045. Epub 2007 Feb 2.
- Background: PubMed 20171803Mahadevan A, Jain S, Goldstein M, Miksad R, Pleskow D, Sawhney M, Brennan D, Callery M, Vollmer C. Stereotactic body radiotherapy and gemcitabine for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):735-42. doi: 10.1016/j.ijrobp.2009.08.046. Epub 2010 Feb 18.
- Background: PubMed 19540061Valentini V, Massaccesi M, Balducci M, Mantini G, Micciche F, Mattiucci GC, Dinapoli N, Meduri B, D'Agostino GR, Salvi G, Nardone L. Low-dose hyperradiosensitivity: is there a place for future investigation in clinical settings? Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):535-9. doi: 10.1016/j.ijrobp.2009.02.075. Epub 2009 Jun 18.
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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.
Bruno Meduri, MD principal investigator
Azienda Ospedaliero-Universitaria Policlinico di Modena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LDR, Gem-based doublets and SBRT in people with Pancreatic Cancer, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
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 6 inclusion and 5 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 12 Dec 2022. 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 Italy. 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.
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 Bruno Meduri, MD (+393388878319, brunomeduri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 1 year). 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 NCT02416609, which also lists 4 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 12 Dec 2022.