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2014-11
2019-03-01
2020-02-19
168
NCT02125136
AIO-Studien-gGmbH
AIO-Studien-gGmbH
INTERVENTIONAL
Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer
The aim ot the study is to investigate the efficacy and safety of two new intensified chemotherapy regimens (gemcitabine (Gem)/nab- paclitaxel (PAC), FOLFIRINOX) as neoadjuvant chemotherapy protocol in locally advanced, non-metastatic pancreatic cancer (LAPC) and consecutive conversion of the tumor to resectability.
This is a prospective open randomized multicenter phase II trial with two arms. Patients suffering from histologically confirmed LAPC (and assessed as unresectable or borderline resectable according to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines "pancreatic adenocarcinoma" version 1.2013) without metastases will receive two different neoadjuvant treatment regimens: First all patients receive two cycles Gem/nab-PAC (duration of each cycle 28 days) as neoadjuvant chemotherapy in equal measure and a first restaging is performed after these two cycles based on imaging criteria. If there is no progression according to Response evaluation criteria in solid tumors (RECIST 1.1) criteria at the first restaging, the patients are randomized in a 1:1 relation to: Two further cycles Gem/nab-PAC (duration of each cycle 28 days). or Four further cycles FOLFIRINOX (duration of each cycle 14 days). After the neoadjuvant chemotherapy a 2nd restaging is performed based on imaging criteria. All patients without progression at this restaging or at an earlier time point undergo obligatory exploratory laparotomy irrespective of imaging criteria to assess resectability. If they are evaluated as converted to resectable during this exploratory laparotomy, pancreas resection in curative intent will be performed. All patients with successful R0 or R1 pancreatic resection will receive three further cycles adjuvant chemotherapy with Gem/nab-PAC. Adjuvant chemotherapy will start within 4 to 8 weeks after pancreatic resection surgery. Further treatment of patients with PD after 1st or 2nd restaging as well as patients with unresectable status based on exploratory laparotomy is under the discretion of the local investigators (e.g. second-line chemotherapy in case of distant relapse or local radiochemotherapy in case of local progression or definitive irresectability). All patients are followed up for local recurrence, progression and survival until death or for at least one year after last application of study drugs whichever is sooner. The translational research conducts exploratory analyses for potential biomarkers of possible prognostic or predictive value for efficacy of neoadjuvant chemotherapy in LAPC; including analyses of circulating tumor cells, molecular pathways of pancreatic adenocarcinoma including SPARC expression.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-04-11 | N/A | 2021-12-14 |
2014-04-28 | N/A | 2021-12-15 |
2014-04-29 | N/A | 2021-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Gem/nab-Pac 2 further cycles Gem/nab-Pac (duration of each cycle 28 days) | DRUG: Gem/nab-Pac
|
| EXPERIMENTAL: FOLFIFINOX 4 cycles combination therapy with 5-fluorouracil/folinic acid, irinotecan, oxaliplatin (FOLFIFINOX) - duration of each cycle 14 days | DRUG: FOLFIFINOX
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Conversion Rate | To compare the effect of intensified neoadjuvant chemotherapy on conversion rate to resectability in LAPC. | approx. 10 month |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Safety | evaluate safety and tolerability of intensified neoadjuvant chemotherapy * Exposure to study drugs * Type, incidence, and severity of adverse events * Dose reduction or discontinuation of study drugs due to adverse events * Laboratory parameters | approx. 22 month |
| objective tumour response rate | assess objective tumour response rate (ORR) to intensified neoadjuvant chemotherapy Baseline tumor measurement(s) will be performed within 4 weeks before the first dose of study drug with either computed tomography (CT) including spiral CT or MRI according to investigator's choice and clinical practice at the respective trial site as done routinely also outside of clinical trial situations.The same method used at baseline must be used consistently for response assessment to neoadjuvant chemotherapy at the first restaging (after the first part of neoadjuvant chemotherapy) and the second restaging (after the second part of neoadjuvant chemotherapy) and thereafter. | approx. 22 month |
| disease control rate (DCR) | assess disease control rate (DCR) after intensified neoadjuvant chemotherapy | approx. 22 month |
| CA 19-9 change | Assess carbohydrate antigen 19-9 (CA 19-9) change during/after neoadjuvant chemotherapy. In this trial, CA 19-9 change to neoadjuvant chemotherapy will be evaluated as decrease to the baseline level at the 1st and 2nd restaging. | 10 month |
| R0 and R1 resections | assess rate of R0 and R1 resections | 10 month |
| pathological responses | assess rate of grade 3 + 4 pathological responses according to grading scheme of treatment responses by Evans in resected patients. | approx. 22 month |
| relapse-free survival (RFS) | assess relapse-free survival (RFS): Relapse-free survival is the time from Day 1 after pancreatic resection to the date of relapse, defined as Day 1 after pancreatic resection to either local relapse of pancreatic cancer or occurrence of distant metastases. For each patient who is not known to have had a relapse as of the data-inclusion cut-off date for a particular analysis, time to relapse will be censored for that analysis at the date of the patient's last study visit prior to that cut-off date. | approx. 22 month |
| Progression-free survival (PFS) | PFS is the time from Day 1 of the first cycle of neoadjuvant chemotherapy to date of objective disease progression or to death of any cause. For each patient who is not known to have had a progression as of the data-inclusion cut-off date for a particular analysis, time to progressive disease will be censored for that analysis at the date of the patient's last study visit prior to that cut-off date. | approx. 2 years |
| perioperative morbidity and mortality | assess perioperative morbidity and mortality | 60 days |
| Tolerability | evaluate safety and tolerability of intensified neoadjuvant chemotherapy (see safety measure) | 10 month |
| Overall Survival (OS) | OS is the time from Day 1 of the first cycle of neoadjuvant chemotherapy to date of death from any cause. The rate of patients who have died from any cause after one year and two years, respectively will be assessed. For each patient for whom it is not known whether he died or is still alive until the data-inclusion cut-off date for a particular analysis, time to death of any cause will be censored for that analysis at the date of the patient's last study visit prior to that cut-off date. | approx. 22 month |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
