Pancreatic CancerPhase 2NCT02984501
Study of Induction Chemotherapy Followed by Radiochemotherapy in Locally Advanced Pancreatic Cancer
A Phase 2 study testing Radiation and Chemotherapy in people with Pancreatic Cancer, run by Campus Bio-Medico University.
Trial summary
There is no a clear consensus regarding the optimal treatment of locally advanced pancreatic disease. There is a potential role for neoadjuvant therapy to treat micrometastatic disease with chemotherapy, as well as for the treatment of local disease with radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Radiation and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Aug 2016
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- proven cytological or histological diagnosis of pancreatic ductal adenocarcinoma;
- borderline resectable or unresectable pancreatic tumours;
- age between 18 and 75 years;
- no previous radiochemotherapy to abdomen;
- 0-I ECOG (Eastern Cooperative Oncology Group) performance status;
- adequate cardiac, liver and kidney function and a good bone marrow reserve.
Who cannot join
- resectable and metastatic disease;
- previous or concomitant malignant disease;
- one or more of the following clinical conditions: infection, pregnancy or breast-feeding, liver failure, kidney failure, Pa O2 < 65 mmHg, Pa CO2 > 40 mmHg, mental disability.
About this study
Official title: Phase II Study of Induction Chemotherapy Followed by Chemoradiotherapy in Patients With Borderline Resectable and Unresectable Locally Advanced Pancreatic Cancer
There is no a clear consensus regarding the optimal treatment of locally advanced pancreatic disease. There is a potential role for neoadjuvant therapy to treat micrometastatic disease with chemotherapy, as well as for the treatment of local disease with radiotherapy. The investigators evaluated the safety and efficacy of induction chemotherapy with oxaliplatin and gemcitabine followed by a high weekly dose of gemcitabine concurrent to radiation therapy in patients with borderline resectable and unresectable locally advanced pancreatic cancer
Read the detailed description
Continued optimization in multimodality therapy and an accurate patient selection remain crucial points for the appropriate treatment of patients with pancreatic cancer.
In all patients an accurate pre-treatment staging was performed, including: physical examination, complete blood tests and tumor markers, endoscopic ultrasonography (EUS) with fine needle aspiration biopsy, multilayer CT scan, PET-CT (positron emission computed tomography) with 18F-2-fluoro-2-deoxy-D-glucose (FDG) and laparoscopy with peritoneal washing. Jaundiced patients before or during treatment underwent endoscopic biliary stenting.
Patients with the evidence of metastatic disease were excluded, and thus only a small number of patients was consequently enrolled with this neoadjuvant approach.
The induction phase of the treatment plan was designed to administer gemcitabine 1000 mg/mq and oxaliplatin 100 mg/mq every 14 days for four doses.
In the combined phase of the treatment all patients underwent simulation by using a Siemens 16-CT simulator (Siemens Medical System). Radiotherapy target volumes were established by CT scan and PET-CT scan.
Four weeks after the completion of radiochemotherapy, restaging, consisting of clinical examination, laboratory test, tumor markers, CT scan and PET-CT scan, was performed. Tumor response was defined in accordance with the World Health Organization (WHO) definition through CT scan and PET-CT scan. Surgery was considered in patients whose tumors were technically resectable.
After resection, patients were evaluated every three months by means of a standard surveillance protocol that included history and physical examination, cross-sectional imaging and measurement of serum markers, and the intervals were extended to six months after two years
- Conditions
- Pancreatic Cancer
- Being tested
- Radiation, Chemotherapy
- Keywords
- radiochemotherapy, neoadjuvant therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Also called Neoadjuvant therapy
Radiotherapy target volumes are established by CT scan and PET-CT scan. Radiotherapy is delivered with a total dose of 54-59 Gy with fractionation of 1.8 Gy daily for 5 days a week. The Planning Target Volume (PTV) is defined by CTV with a safety margin of 1cm in all directions to include organ motion and set-up errors. Organs at risk for radiation-induced side effects are contoured on the dose planning CT and dose volume histograms (DVH) are calculated. All treatments are delivered with a 15-MV linear accelerator (Varian Medical System) with a multifield isocentric technique using a multileaf collimator. A quality-control protocol are applied for all patients with periodical digital portal images to evaluate the precision of the set-up.
ChemotherapyDrug
Also called Induction therapy
The induction phase of the treatment plan is designed to administer gemcitabine 1000 mg/mq and oxaliplatin 100 mg/mq every 14 days for four doses. Chemotherapy concurrent to conformal radiation therapy is gemcitabine at the dose of 600 mg/mq weekly.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Patients treated with induction chemotherapy with gemcitabine and oxaliplatin; for patients without disease progression as detected through restaging exams, chemotherapy was followed by radiochemotherapy which consisted of conformal radiation therapy and concurrent gemcitabine at the dose of 600 mg/mq weekly. Receives: Radiation: Radiation; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
During treatment, patients are evaluated through a directed history, weekly physical examination and blood exams. The occurrence and nature of any adverse events are recorded in accordance with the National Cancer Institute Common Toxicity Criteria (version 4.0) scale. When multiple treatment-related adverse events of the same type occurred in the same patient, only the most severe ones are reported. Subsequently, the dose of chemotherapy is adjusted according to the number of occurrences of grade 2 or greater events.
Measured: four months
Secondary outcomes (4)
Overall Survival
Measured: 3 years
Progression-free survival
Measured: 3 years
metastases-free survival
Measured: 3 years
Incidence of Local-regional Tumor Control
Patients are not considered to have local-regional control unless they achieve at least a partial response of their primary tumor or stable disease by imaging. Patients who do not achieve objective response are considered to have local-regional failure. Local-regional control rates are analyzed using the Kaplan-Meier method.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startMar 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Fiore, Campus Bio-Medico University
- Investigators
- Lucio Trodella, MD, Study director, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984501
- Sponsor's protocol ID
- 20/13 PAR ComEt CBM
- Status last verified
- Dec 2016
- First submitted
- 28 Nov 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Induction Chemotherapy Followed by Chemoradiotherapy in Patients With Borderline Resectable and Unresectable Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02984501
- Acronym / sponsor ID
- 20/13 PAR ComEt CBM
- Conditions
- Pancreatic Cancer
- Keywords
- radiochemotherapy, neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Dec 2016 (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.
There is no a clear consensus regarding the optimal treatment of locally advanced pancreatic disease. There is a potential role for neoadjuvant therapy to treat micrometastatic disease with chemotherapy, as well as for the treatment of local disease with radiotherapy. The investigators evaluated the safety and efficacy of induction chemotherapy with oxaliplatin and gemcitabine followed by a high weekly dose of gemcitabine concurrent to radiation therapy in patients with borderline resectable and unresectable locally advanced pancreatic cancer
Detailed description
Continued optimization in multimodality therapy and an accurate patient selection remain crucial points for the appropriate treatment of patients with pancreatic cancer.
In all patients an accurate pre-treatment staging was performed, including: physical examination, complete blood tests and tumor markers, endoscopic ultrasonography (EUS) with fine needle aspiration biopsy, multilayer CT scan, PET-CT (positron emission computed tomography) with 18F-2-fluoro-2-deoxy-D-glucose (FDG) and laparoscopy with peritoneal washing. Jaundiced patients before or during treatment underwent endoscopic biliary stenting.
Patients with the evidence of metastatic disease were excluded, and thus only a small number of patients was consequently enrolled with this neoadjuvant approach.
The induction phase of the treatment plan was designed to administer gemcitabine 1000 mg/mq and oxaliplatin 100 mg/mq every 14 days for four doses.
In the combined phase of the treatment all patients underwent simulation by using a Siemens 16-CT simulator (Siemens Medical System). Radiotherapy target volumes were established by CT scan and PET-CT scan.
Four weeks after the completion of radiochemotherapy, restaging, consisting of clinical examination, laboratory test, tumor markers, CT scan and PET-CT scan, was performed. Tumor response was defined in accordance with the World Health Organization (WHO) definition through CT scan and PET-CT scan. Surgery was considered in patients whose tumors were technically resectable.
After resection, patients were evaluated every three months by means of a standard surveillance protocol that included history and physical examination, cross-sectional imaging and measurement of serum markers, and the intervals were extended to six months after two years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Radiation: Radiation, Drug: ChemotherapyPatients treated with induction chemotherapy with gemcitabine and oxaliplatin; for patients without disease progression as detected through restaging exams, chemotherapy was followed by radiochemotherapy which consisted of conformal radiation therapy and concurrent gemcitabine at the dose of 600 mg/mq weekly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- proven cytological or histological diagnosis of pancreatic ductal adenocarcinoma;
- borderline resectable or unresectable pancreatic tumours;
- age between 18 and 75 years;
- no previous radiochemotherapy to abdomen;
- 0-I ECOG (Eastern Cooperative Oncology Group) performance status;
Key exclusion criteria (3 listed)
- resectable and metastatic disease;
- previous or concomitant malignant disease;
- one or more of the following clinical conditions: infection, pregnancy or breast-feeding, liver failure, kidney failure, Pa O2 < 65 mmHg, Pa CO2 > 40 mmHg, mental disability.
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 |
|---|---|---|
| RadiationAlso: Neoadjuvant therapyRadiotherapy target volumes are established by CT scan and PET-CT scan. Radiotherapy is delivered with a total dose of 54-59 Gy with fractionation of 1.8 Gy daily for 5 days a week. The Planning Target Volume (PTV) is defined by CTV with a safety margin of 1cm in all directions to include organ motion and set-up errors. Organs at risk for radiation-induced side effects are contoured on the dose planning CT and dose volume histograms (DVH) are calculated. All treatments are delivered with a 15-MV linear accelerator (Varian Medical System) with a multifield isocentric technique using a multileaf collimator. A quality-control protocol are applied for all patients with periodical digital portal images to evaluate the precision of the set-up. | Radiation | Single Arm |
| ChemotherapyAlso: Induction therapyThe induction phase of the treatment plan is designed to administer gemcitabine 1000 mg/mq and oxaliplatin 100 mg/mq every 14 days for four doses. Chemotherapy concurrent to conformal radiation therapy is gemcitabine at the dose of 600 mg/mq weekly. | Drug | Single Arm |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: four months
During treatment, patients are evaluated through a directed history, weekly physical examination and blood exams. The occurrence and nature of any adverse events are recorded in accordance with the National Cancer Institute Common Toxicity Criteria (version 4.0) scale. When multiple treatment-related adverse events of the same type occurred in the same patient, only the most severe ones are reported. Subsequently, the dose of chemotherapy is adjusted according to the number of occurrences of grade 2 or greater events.
4 secondary outcomes
Overall Survival
Time frame: 3 years
Progression-free survival
Time frame: 3 years
metastases-free survival
Time frame: 3 years
Incidence of Local-regional Tumor Control
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Lucio Trodella, MD study director
Campus Bio-Medico University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation and Chemotherapy in people with Pancreatic Cancer, run by Campus Bio-Medico University.
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 3 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: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2016.