GAP: Phase II gemcitabine and nab-paclitaxel for resectable pancreas cancer

Phase 2

Completed

• Conditions: Resectable pancreas cancer; Cancer - Pancreatic

• Registration Number: ACTRN12611000848909
• Lead Sponsor: AGITG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate R0 surgical resection rate in patients with resectable pancreatic cancer following pre-operative treatment with gemcitabine and nab-paclitaxel. (R0 resection rate). <br>This will be determined by histopathological examination at the study site with a determination made if there is any microscopic disease left after surgery (R0). This will later be centrally reviewed by a histopatholgoist as quality assurance (all patients will have their slides reviewed centrally).[After Surgery]