Pancreatic CancerPhase 2NCT01531712
Study of Neoadjuvant Treatment in Patients With Pancreatic Cancer That is Potentially Resectable
A Phase 2 study testing Gemcitabine, Radiotherapy and Tarceva in people with Pancreatic Cancer, run by Institut Català d'Oncologia at 1 site in Spain.
Trial summary
Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed by chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with borderline resectability. 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?
- Gemcitabine, Radiotherapy and Tarceva
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2011to Dec 2012
- 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
- Before the beginning of the specific protocol procedures must be obtained and documented a written consent form. Patients must have sufficient capacity to understand and sign the consent form.
- Exocrine pancreatic potentially resectable carcinoma, histologically confirmed.
- Aged 18-75 years.
- OMS functional state (FE) from 0-2 and Karnofsky functional state 70%.
- Radiologically or measurable disease, defined as borderline resectability disease.
- Appropriate biological parameters: neutrophils > 1.500/mL; platelets > 100.000/mL; hemoglobin > 10 g/dl.Serum creatinine < 1,5 x upper limit of normal (LSN); alkaline phosphatase < 3 x LSN and bilirubin < 1,5 x LSN; AST and ALT 2,5 x LSN.
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- Controlled biliary obstruction in all the patients before their inclusion in the study.
- Absence of peripheral neuropathy grade 2.
- Life expectancy of at least 3 months.
Who cannot join
- Previous administration of chemotherapy, radiotherapy or any investigational agents for pancreatic cancer treatment.
- Administration of other experimental treatment during this study or in the previous 6 months.
- Pregnancy, inappropriate or unsafe use of contraceptive methods or women who are breast-feeding.
- Clinically significant heart disease(for example: congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not properly controlled with medication or myocardial infarction in the last 12 months).
- Presence of significant ophthalmologic anomaly, included: severe dry eye syndrome, Sjogren syndrome, dry keratoconjunctivitis, severe exposure keratopathy, conditions that might increase the risk of epithelium complications.
- Patients with lack of physical integrity of the upper gastrointestinal tract or bad absorption syndromes or unable to ingest the tablets.
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- Other previous bad or concurrent diseases, with the exception of nonmelanoma skin cancer.
- Medical or psychiatric pathologies that are severe or uncontrolled.
- Distant metastases.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Phase II Study of Neoadjuvant Treatment With Gemcitabine, Tarceva and Oxaliplatin Followed by Chemotherapy With Tarceva and Gemcitabine in Patients With Pancreas Adenocarcinoma With Borderline Resectability.
Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed by chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with borderline resectability. The primary objective is to determine the resectability rate of patients with pancreas adenocarcinoma with borderline resectability determined radiologically, treated with Gemcitabine, Tarceva and Oxaliplatin followed by radiotherapy with Gemcitabine and Tarceva.
Read the detailed description
Patients with borderline resectable pancreatic adenocarcinoma are more likely to develop perioperative complications due to the complexity of surgery. In these patients there is also an increased risk of systemic relapse due to the advanced stage of the tumor as well as a higher possibility of having positive margins. Therefore, the treatment of these patients need to be decided based on a multidisciplinary strategy. Besides of that the use of systemic neoadjuvant chemotherapy as induction therapy, followed by sequential chemoradiotherapy is a very attractive therapeutic modality.
The neoadjuvant treatment offers the potential advantages of reducing the tumor stage, increasing resectability and decreasing postoperative complications.
The administration of chemotherapy and radiotherapy before surgery represent an strategy for early treatment of micrometastatic disease, present in most of these patients, and to identify patients with rapid progression of the disease.
For all the reasons above, the investigators consider it's of great interest to design new studies that combine systemic neoadjuvant chemotherapy followed by chemoradiotherapy with neoadjuvant intention in patients with pancreas cancer locally advanced.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, Radiotherapy, Tarceva, Oxaliplatin
- Keywords
- neoadjuvant treatment, borderline resectability
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called gemzar
1000mg/m2 / / 40mg/m2
RadiotherapyRadiation
50.4 Gy
TarcevaDrug
Also called Erlotinib
100mg/day
OxaliplatinDrug
Also called ELOXATIN
100mg/m2 (only in QT)
| Study group | Role | What they receive |
|---|---|---|
| QT + QRT | Experimental | Chemotherapy (6 cycles x 14 days): Gemcitabine 1000 mg/m2 (day 1) + Oxaliplatin 100 mg/m2 (day 2) + Tarceva 100 mg/day.
Chemoradiotherapy (5,5 weeks): Gemcitabine 40 mg/m2 (2 days/week) + Tarceva 100 mg/day + Radiotherapy (1,8 Gy/day x 28 doses, total dose: 50,4 Gy). Receives: Drug: Gemcitabine; Radiation: Radiotherapy; Drug: Tarceva; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy.
Determine the resectability rate of subjects with borderline resectable pancreatic cancer (radiologically measured) that were treated with Gemcitabine, Tarceva and Oxaliplatin followed by chemoradiotherapy with Gemcitabine and Tarceva.
Measured: Two years
Secondary outcomes (7)
Median overall survival.
To determine the overall survival (OS) and the tumor recurrence pattern (local versus distant).
Measured: Two years
Rate of resections with engative margins and complete pathological response.
To determine the rate of negative margin resections and complete pathological response (cPR).
Measured: Two years
Response rate to neoadjuvant treatment of tumor markers (CEA, CA19-9)
To determine the reponse rate to the neoadjuvant treatment of speficic tumor markers (CEA, Ca19-9).
Measured: Two years
Ratio of objective responses (RECIST).
To determine the ratio of objective responses according to RECIST criteria.
Measured: Two years
Prognosis accuracy of serum protein profiles
To determine the prognosis accuracy of serum protein profiles in these subjects.
Measured: Two years
Viability of the collection of pre-treatment tumor samples
To determine the feasibility of the collection of pre-treatment (baseline) tumor samples and to set pathological correlations with the response after neoadyuvant treatment.
Measured: Two years
Adverse events
To determine the safety, toxicity and feasibility of this therapeutical regimen as neoadyuvant treatment.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study start10 Feb 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Due to a low recruitment rate since start of recruitment period.
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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berta Laquente, MD, Principal investigator, ICO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531712
- Sponsor's protocol ID
- ICO-20431
- Other IDs
- 2010-021872-27, GEMERLOXA
- Status last verified
- Aug 2017
- First submitted
- 11 Jan 2012
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Treatment With Gemcitabine, Tarceva and Oxaliplatin Followed by Chemotherapy With Tarceva and Gemcitabine in Patients With Pancreas Adenocarcinoma With Borderline Resectability.
- ClinicalTrials.gov ID
- NCT01531712
- Acronym / sponsor ID
- ICO-20431
- Conditions
- Pancreatic Cancer
- Keywords
- neoadjuvant treatment, borderline resectability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a low recruitment rate since start of recruitment period.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Study start
- 10 Feb 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Feb 2012 (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.
Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed by chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with borderline resectability. The primary objective is to determine the resectability rate of patients with pancreas adenocarcinoma with borderline resectability determined radiologically, treated with Gemcitabine, Tarceva and Oxaliplatin followed by radiotherapy with Gemcitabine and Tarceva.
Detailed description
Patients with borderline resectable pancreatic adenocarcinoma are more likely to develop perioperative complications due to the complexity of surgery. In these patients there is also an increased risk of systemic relapse due to the advanced stage of the tumor as well as a higher possibility of having positive margins. Therefore, the treatment of these patients need to be decided based on a multidisciplinary strategy. Besides of that the use of systemic neoadjuvant chemotherapy as induction therapy, followed by sequential chemoradiotherapy is a very attractive therapeutic modality.
The neoadjuvant treatment offers the potential advantages of reducing the tumor stage, increasing resectability and decreasing postoperative complications.
The administration of chemotherapy and radiotherapy before surgery represent an strategy for early treatment of micrometastatic disease, present in most of these patients, and to identify patients with rapid progression of the disease.
For all the reasons above, the investigators consider it's of great interest to design new studies that combine systemic neoadjuvant chemotherapy followed by chemoradiotherapy with neoadjuvant intention in patients with pancreas cancer locally advanced.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QT + QRT | Experimental | Drug: Gemcitabine, Radiation: Radiotherapy, Drug: Tarceva, Drug: OxaliplatinChemotherapy (6 cycles x 14 days): Gemcitabine 1000 mg/m2 (day 1) + Oxaliplatin 100 mg/m2 (day 2) + Tarceva 100 mg/day. Chemoradiotherapy (5,5 weeks): Gemcitabine 40 mg/m2 (2 days/week) + Tarceva 100 mg/day + Radiotherapy (1,8 Gy/day x 28 doses, total dose: 50,4 Gy). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Before the beginning of the specific protocol procedures must be obtained and documented a written consent form. Patients must have sufficient capacity to understand and sign the consent form.
- Exocrine pancreatic potentially resectable carcinoma, histologically confirmed.
- Aged 18-75 years.
- OMS functional state (FE) from 0-2 and Karnofsky functional state 70%.
- Radiologically or measurable disease, defined as borderline resectability disease.
Key exclusion criteria (9 listed)
- Previous administration of chemotherapy, radiotherapy or any investigational agents for pancreatic cancer treatment.
- Administration of other experimental treatment during this study or in the previous 6 months.
- Pregnancy, inappropriate or unsafe use of contraceptive methods or women who are breast-feeding.
- Clinically significant heart disease(for example: congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not properly controlled with medication or myocardial infarction in the last 12 months).
- Presence of significant ophthalmologic anomaly, included: severe dry eye syndrome, Sjogren syndrome, dry keratoconjunctivitis, severe exposure keratopathy, conditions that might increase the risk of epithelium complications.
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 |
|---|---|---|
| GemcitabineAlso: gemzar1000mg/m2 / / 40mg/m2 | Drug | QT + QRT |
| Radiotherapy50.4 Gy | Radiation | QT + QRT |
| TarcevaAlso: Erlotinib100mg/day | Drug | QT + QRT |
| OxaliplatinAlso: ELOXATIN100mg/m2 (only in QT) | Drug | QT + QRT |
Primary outcome
Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy.
Time frame: Two years
Determine the resectability rate of subjects with borderline resectable pancreatic cancer (radiologically measured) that were treated with Gemcitabine, Tarceva and Oxaliplatin followed by chemoradiotherapy with Gemcitabine and Tarceva.
7 secondary outcomes
Median overall survival.
Time frame: Two years
Rate of resections with engative margins and complete pathological response.
Time frame: Two years
Response rate to neoadjuvant treatment of tumor markers (CEA, CA19-9)
Time frame: Two years
Ratio of objective responses (RECIST).
Time frame: Two years
Prognosis accuracy of serum protein profiles
Time frame: Two years
Viability of the collection of pre-treatment tumor samples
Time frame: Two years
Adverse events
Time frame: Two years
Results and safety
The study was stopped early (reason given: Due to a low recruitment rate since start of recruitment period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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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.
Berta Laquente, MD principal investigator
ICO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Radiotherapy and Tarceva in people with Pancreatic Cancer, run by Institut Català d'Oncologia at 1 site in Spain.
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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Aug 2017. 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 Spain. 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 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 was stopped early (reason given: Due to a low recruitment rate since start of recruitment period.). Results are not available in the source record.
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?
Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy. (time frame: Two years). 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 29 Aug 2017.