- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2019-03-05
2021-08-19
2021-08-19
31
NCT04176952
University of Glasgow
University of Glasgow
INTERVENTIONAL
PRIMUS002: Looking at 2 Neo-adjuvant Treatment Regimens for Resectable and Borderline Resectable Pancreatic Cancer
PRIMUS 002 is looking at 2 different chemotherapy regimens in the neo-adjuvant setting for pancreatic cancer. Each treatment will be given for 3 months prior to surgery
This is an integrated, open label, non-randomised, phase II trial of 2 neo-adjuvant regimens (FOLFOX-A and AG) assessing efficacy and toxicity with integrated translational work. The study is powered on testing a proposed DNA damage response deficient biomarker for responsiveness in patients treated with FOLFOX-A; patients being treated with AG are recruited concurrently. The study has a prospective safety assessment of neo-adjuvant chemotherapy and neo-adjuvant chemotherapy followed by chemoradiotherapy consisting of conventional radiotherapy with concomitant capecitabine. This safety assessment will include all patients (FOLFOX-A and AG)
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 |
|---|---|---|
2019-10-28 | N/A | 2022-05-17 |
2019-11-21 | N/A | 2022-05-24 |
2019-11-26 | N/A | 2022-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: FOLFOX-A FOLFOX A arm (14-day cycle) * nab-paclitaxel: 150mg/m2 IV over 30 minutes, day 1 (administered first). * Oxaliplatin: 85mg/m2, IV over 2 hours, day 1. * Folinic acid: 350mg flat dose, IV over 2 hours, day 1. * Fluorouracil infusion:1200mg/m2/day, as a co | DRUG: FOLFOX-A
|
| ACTIVE_COMPARATOR: Abraxane and Gemcitabine Nab-Paclitaxel + Gemcitabine (AG) arm (28-day cycle) * nab-paclitaxel: 125mg/m2 IV over 30 minutes on days 1, 8 and 15 (administered first). * Gemcitabine 1000mg/m2 IV over 30 minutes on days 1, 8 and 15 (immediately following nab-paclitaxel). | DRUG: AG
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Time to progression post FOLFOX-A induction treatment | date of progression after FOLFOX-A neo-adjuvant chemotherapy as assessed by RECIST 1.1 | CT scans will take place at baseline, pre chemoradiotherapy and pre surgery, over approximately 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Proving liquid biopsies can be used to define patient subgroups | a liquid biopsy will be taken and analysed using circulating tumour DNA at different timepoints to see if these can be used to define patient subgroups | From date of registration to date of surgery. On average 4 months after registration |
| Response post neo-adjuvant chemotherapy | CT scans will be reported to RECIST 1.1 and best response will be evaluated | CT scan will be performed at baseline and then post neo-adjuvant chemotherapy (approximately 3 months later) |
| College of American Pathologists tumour regression grade | CAP tumour regression grade (grade 0-3 with 0 being no viable residual tumour and 3 being poor to no response) will be assessed post surgery | Post surgery which will be approximately 4 months post registration |
| R0 rate post surgery | R0 rate will be assessed post surgery | Post surgery which will be approximately 4 months post registration |
| Overall survival | Overall survival will be assessed in all patients | From date of registration until date of death assessed for up to 5 years post registration |
| Disease free survival | Disease free survival will be assessed at every follow up visit | from date of registration until date of disease recurrence assessed for at least 24 months post registration |
| Safety and tolerability of study drugs: NCI CTCAE 4.03 | Safety and tolerability will be assessed as per NCI CTCAE 4.03 | Assessed at every clinic visit during treatment, for approximately 3 months post registration |
| Safety and tolerability of chemoradiotherapy: NCI CTCAE 4.03 | Safety and tolerability of chemoradiotherapy will be assessed as per NCI CTCAE 4.03 | Assessed at every chemoradiotherapy visit and pre-surgery (once Chemoradiotherapy added). Chemoradiotherapy will take place 5 days a week for three weeks |
| Surgical complication rate | Rate of surgical complication as assessed by NCI CTCAE 4.03 | Assessed post surgery, approximately 4 months post registration |
| Neurotoxicity | Assessed by GOG NTX4 (4 questions graded from 0 (not at all) to 4 (very much). quality of life will be assessed using the GOG NTX4 tool at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months) | Neurotoxicity will be assessed from registration until study is completed at various timepoints until patient death. Each patient will be followed up for at least 24 months post registration |
| Quality of life assessed by EORTC QLQ-C30 | quality of life will be assessed using the EORTC QLQ C30 tool at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months for a minimum of 24 months). The Quality of life tool is comprised of 28 questions that the patient answers either 1-4 (1 = not at all, 4 = Very much) and 2 questions that are on al scale of 1 - 7 where 1 = very poor and 7 = excellent | Quality of life will be assessed from registration until study is completed at various timepoints until patient death. Each patient will be followed up for at least 24 months post registration |
| Quality of life assessed by EORTC QLQ-PAN26 | quality of life will be assessed using the EORTC QLQ-PAN26 tool at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months for a minimum of 24 months). The Quality of life tool is comprised of 26 questions that the patient answers either 1-4 (1 = not at all, 4 = Very much) | Quality of life will be assessed from registration until study is completed at various timepoints until patient death. Each patient will be followed up for at least 24 months post registration |
| Health Economics | Health economics defined as number of visits to hospital per patient, both as an inpatient and as an outpatient will be assessed at the following timepoints: Baseline, month 1, month 2, month 3, pre chemoradiotherapy, between fraction 11 and 15 of chemoradiotherapy, pre surgery, at every follow-up visit (6, 9, 12 months post registration then every 6 months for a minimum of 24 months) | Health economics will be assessed from registration until study is completed at various timepoints until patient death. Each patient will be followed up for at least 24 months post registration |
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:
16 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
