Protocol title: Phase II study of pre-operative Gemcitabine and nab-Paclitaxel for Resectable Pancreas Cancer.
Study Chairs: Prof. Andrew Barbour (Princess Alexandra Hospital, Woolloongabba QLD); and Prof. David Goldstein (Prince of Wales Hospital, Randwick NSW)
Associate Oncology Program Manager: Cheryl Friend
Trial Coordinator: Jenna Mitchell
Contact Email: firstname.lastname@example.org
Detailed information available on the Australian and New Zealand Clinical Trials Registry — GAP
This trial aims to evaluate complete resection rates (R0) with the addition of pre-operative chemotherapy in pancreatic cancer. It also aims to define surrogate endpoints of response to pre-operative chemotherapy. In addition, the trial seeks to carefully define treatment-related toxicity and treatment failure.
Over 2500 Australians are diagnosed with pancreatic cancer each year, making research in this disease a high priority. The 5-year survival of patients undergoing surgery is still low at 20% despite improvements of surgical care and the addition of adjuvant therapy. Local and distant recurrence are frequent problems following resection of pancreas adenocarcinoma with curative intent. As a result, adjuvant and neoadjuvant protocols using radiotherapy (RT), chemotherapy (CT), or multimodality treatment have been investigated.
Both Palmer and Heinrich showed promising overall survival (OS) [62% 12 month survival and 26.5 months OS respectively] after neoadjuvant chemotherapy with a high percentage of patients able to proceed to surgery [62% and 80%]. The recent data presented by Von Hoff et al. suggests that the combination of gemcitabine and Abraxane (nab-paclitaxel) represents a major enhancement in response [58%] and overall survival (12.2 months) in the first line setting. Neoadjuvant therapy is able to identify patients with aggressive tumour biology who may be spared the morbidity of resection while also identifying those patients most likely to benefit from radical therapy.
Recent data from the New South Wales Pancreatic Cancer Network clearly demonstrated poorer survival among 132/365 (35%) patients with R1 resections. The administration of pre-operative CT has been postulated as a factor that may affect the prognostic significance of margin status. Studies from the MD Anderson Cancer Center suggest a treatment effect of >50% in the specimen can be considered a response to treatment. Further exploration regarding the validity of these histological surrogate endpoints is required in addition to surrogate endpoints for the development of future clinical trials, including candidates such as Ca19.9 and FDG-PET.
Non-randomised phase II study with parallel arms post-surgery based on resection outcome at surgery. The study will require 50 patients to be registered in total from approximately 12 sites in Australia. Patients will be accrued over 2.5 years and followed up for a minimum of 12 months.
GAP-T – NHMRC project grant to support biological and PET sub-study granted in October 2011.
To view study schema click here.