None listed
Conditions
Brief summary
This study aims to determine the effect of pre-operative chemotherapy in patients with resectable pancreatic cancer. Patients may be eligible to join this study if they are aged 18 years or more and have been diagnosed with cancer of the pancreas for which they plan to undergo surgery. All participants in this trial will undergo pre-operative chemotherapy with the drugs gemcitabine and nab-paclitaxel. The chemotherapy will be administered intravenously on day 1, day 8 and day 15 of a 28 day cycle. Patients will receive 2 cycles before undergoing surgery to remove their cancer. Participants will be assessed after surgery to determine whether all the cancerous tissue has been successfully removed. If all the cancer has been removed the patients will have another 4 cycles of chemotherapy with gemcitabine and nab-paclitaxel. If all the cancer is not removed during surgery, the treating clinician may decide that patients will receive radiotherapy everyday for 5 weeks, at the same time as receiving a continuous infusion of 5-flurouracil which will then be followed by 4 cycles of chemotherapy with gemcitabine and nab-paclitaxel. They may also decide to to treat patients with chemotherapy as described for patients who have had all their cancer removed. Blood tests and safety assessments will also be regularly conducted throughout the 12 month duration of the trial. The results from this study will be compared to previous data to determine whether pre-operative chemotherapy will improve resection, and thus, survival outcomes in patients with pancreatic cancer.
Interventions
2 pre-operative chemotherapy cycles with 1000mg/m2 gemcitabine and 125mg/m2 nab-paclitaxel given intravenously on day 1, day 8 and day 15 of a 28 day cycle. Patient will then undergo surgical resection of their pancreas cancer with curative intent. Patients will be allocated to receive different post surgical adjuvent treatment depending on their surgical outcome. R0 (complete resection) patients will recieve 4 further cycles of gemcitabine 1000mg/m2 and 125mg/m2 nab-paclitaxel as described abov
2 pre-operative chemotherapy cycles with 1000mg/m2 gemcitabine and 125mg/m2 nab-paclitaxel given intravenously on day 1, day 8 and day 15 of a 28 day cycle. Patient will then undergo surgical resection of their pancreas cancer with curative intent. Patients will be allocated to receive different post surgical adjuvent treatment depending on their surgical outcome. R0 (complete resection) patients will recieve 4 further cycles of gemcitabine 1000mg/m2 and 125mg/m2 nab-paclitaxel as described above. R1 (incomplete resection) patients will receive 45Gy radiation in 20 fractions daily over 5 weeks in combination with continous infusion of 5FU 200mg/m2/day for the duration of the radiotherapy. This is then followed by 4 cycles of gemcitabine and nab-paclitaxel chemotherapy as described above OR chemotherapy as per R0 resection outcome group (at treating clinician's discretion)
Sponsors
AGITG
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Males or females with histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas. In those patients with histology or cytology highly suspicious for adenocarcinoma, the diagnosis of pancreatic adenocarcinoma will be made by integrating this histological data with the clinical and radiographic data (tumour mass visible on three phase CT scan (or MRI scan) of the pancreas). Patients with islet cell neoplasms are excluded; -Disease is clearly resectable on the basis of physical examination and the following objective CT criteria (or MRI if indicated): (i) no evidence of extra-pancreatic disease; (ii) no evidence of tumour abutment of the superior mesenteric artery (SMA) or coeliac axis (T4); and (iii) no evidence of portal vein infiltration of more than 180 degrees of the circumference or occlusion of the superior mesenteric vein (SMV) or SMV–portal vein (PTV) confluence.
Exclusion criteria
- Patient considered to have a borderline resectable tumour. - Patients with locally advanced disease. - Evidence of systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery, chemotherapy or chemoradiotherapy. - Concurrent illness including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
Outcome results
None listed