Locally Advanced Pancreatic AdenocarcinomaNCT01278368
Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection
A study testing Pancreatic resection after preoperative chemotherapy and Pancreatic resection in people with Locally Advanced Pancreatic Adenocarcinoma, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Pancreatic Adenocarcinoma
- What is being tested?
- Pancreatic resection after preoperative chemotherapy and Pancreatic resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2003to Dec 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of pancreatic cancer
- Preoperative chemotherapy
- Pancreatic resection
Who cannot join
- Metastatic disease
- ASA score 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREOPERATIVE CHEMOTHERAPY DOES NOT ADVERSELY AFFECT SHORT-TERM OUTCOME AFTER PANCREATIC RESECTION.
No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.
Read the detailed description
Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).
- Being tested
- Pancreatic resection after preoperative chemotherapy, Pancreatic resection
- Keywords
- pancreatic cancer, neoadjuvant chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic resection after preoperative chemotherapyProcedure or surgery
Pancreatic resection after preoperative chemotherapy
Pancreatic resectionProcedure or surgery
Pancreatic resection
| Study group | Role | What they receive |
|---|---|---|
| Preoperative chemotherapy (PCHT) | Active comparator | Patients who underwent pancreatic resection after PCHT. Receives: Procedure: Pancreatic resection after preoperative chemotherapy |
| Control | Active comparator | Patient who underwent pancreatic resection without preoperative therapy Receives: Procedure: Pancreatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morbidity rate
Measured: Postoperative. From 0 to 30 days after discharge
Secondary outcomes (2)
Postoperative mortality
Measured: Postoperative. From 0 to 30 days after discharge
Length of hospital stay (LOS)
Measured: Postoperative. From 0 to 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2003
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic AdenocarcinomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Braga, Università Vita-Salute San Raffaele
- Investigators
- Marco Braga, MD, Principal investigator, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278368
- Sponsor's protocol ID
- NEOADJUVANT_MATCH
- Status last verified
- Dec 2012
- First submitted
- 14 Jan 2011
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREOPERATIVE CHEMOTHERAPY DOES NOT ADVERSELY AFFECT SHORT-TERM OUTCOME AFTER PANCREATIC RESECTION.
- ClinicalTrials.gov ID
- NCT01278368
- Acronym / sponsor ID
- NEOADJUVANT_MATCH
- Keywords
- pancreatic cancer, neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Jan 2011 (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.
No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.
Detailed description
Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative chemotherapy (PCHT) | Active comparator | Procedure: Pancreatic resection after preoperative chemotherapyPatients who underwent pancreatic resection after PCHT. |
| Control | Active comparator | Procedure: Pancreatic resectionPatient who underwent pancreatic resection without preoperative therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of pancreatic cancer
- Preoperative chemotherapy
- Pancreatic resection
Key exclusion criteria (2 listed)
- Metastatic disease
- ASA score 4
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 |
|---|---|---|
| Pancreatic resection after preoperative chemotherapyPancreatic resection after preoperative chemotherapy | Procedure or surgery | Preoperative chemotherapy (PCHT) |
| Pancreatic resectionPancreatic resection | Procedure or surgery | Control |
Primary outcome
Postoperative morbidity rate
Time frame: Postoperative. From 0 to 30 days after discharge
2 secondary outcomes
Postoperative mortality
Time frame: Postoperative. From 0 to 30 days after discharge
Length of hospital stay (LOS)
Time frame: Postoperative. From 0 to 30 days after discharge
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 24 Dec 2012.
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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.
Marco Braga, MD principal investigator
Università Vita-Salute San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatic resection after preoperative chemotherapy and Pancreatic resection in people with Locally Advanced Pancreatic Adenocarcinoma, run by Università Vita-Salute San Raffaele 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 3 inclusion and 2 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 24 Dec 2012. 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?
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?
Postoperative morbidity rate (time frame: Postoperative. From 0 to 30 days after discharge). 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 24 Dec 2012.