- GAP
Trial Status
Completed
Cancer Type
Pancreatic Cancer
Protocol Title
Phase II study of Gemcitabine and nab‐Paclitaxel for Resectable Pancreas Cancer.
Purpose of the Study
The primary objective of the GAP trial is to determine the effect of pre-operative chemotherapy in patients with pancreatic cancer. Other objectives are to determine markers of response to pre-operative chemotherapy and treatment-related toxicity.
Pancreatic cancers diagnosed in early stages can be treated with surgery. For pancreatic cancer surgery to be considered successful there must be no cancer remaining after surgery; this is often hard to achieve due to the proximity of the pancreas to vital structures. The 5–year survival rate of patients undergoing surgery is approximately 20%.
Studies have suggested that chemotherapy before surgery may improve outcomes in patients.
The GAP trial evaluated the impact of pre-operative chemotherapy on the outcome of the surgery to remove the cancer. In addition, it assessed treatment-related toxicity. This study has the potential to assess the benefit of chemotherapy treatment before surgery and after surgery for people with pancreatic cancer.
Key Eligibility Criteria
Inclusion Criteria
- Males or females with histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas.
- Disease is clearly resectable portal vein (PTV) confluence.
- Years
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.
More Information
More information available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.
Principal Investigator
Prof Andrew Barbour
Funding
Australasian Gastro-Intestinal Trials Group (AGITG)
Specialised Therapeutics Australia
Trial Status
Completed
Cancer Type
Pancreatic Cancer
Protocol Title
Phase II study of Gemcitabine and nab‐Paclitaxel for Resectable Pancreas Cancer.
Conference Presentation Reference
- Barbour A, O’Rourke N, Chan H, Chua YJ, Kench J, Hicks RJ, Samra JS, Pavlakis N, Haghighi KS, Yip S, Donoghoe M, Friend C, Burge Me, Fawcett J, Harris M, Aghmesheh M, Joubert WL, Gebski V, Simes J, Goldstein D. Initial survival outcomes for the AGITG GAP study: a phase II study of perioperative nab-paclitaxel and gemcitabine for resectable pancreatic ductal adenocarcinoma. American Society of Clinical Oncology Annual Meeting; 3–7 Jun 2016; Chicago.
- Barbour A, O’Rourke N, Chandrasegaram MD, Chua YJ, Kench J, Samra JS, Pavlakis N, Haghighi KS, Yip S, Fawcett J, Donoghoe M, Walker K, Burge ME, Gananadha S, Harris M, Aghmesheh M, Joubert WL, Gebski V, Simes J, Goldstein D. A multicenter, phase II trial of preoperative gemcitabine and nab-paclitaxel for resectable pancreas cancer: the AGITG GAP study. American Society of Clinical Oncology Annual Meeting; 29 May−2 Jun 2015; Chicago.
- Barbour A, O’Rourke N, Samra JS, Haghighi KS, Kench J, Mitchell J, Pavlakis N, Burge ME, Fawcett J, Gananadha S, Harris M, Aghmesheh M, Chua YJ, Joubert WL, Chan MMK, Chandrasegaram MD, Yip S, Simes J, Gebski V, Goldstein D. A multicenter, phase II trial of preoperative gemcitabine and nab-paclitaxel for resectable pancreas cancer: the AGITG GAP study. Gastrointestinal Cancers Symposium; 15–17 Jan 2015; San Francisco.
Aim
The primary objective of the GAP trial is to determine the effect of pre-operative chemotherapy in patients with pancreatic cancer. Other objectives are to determine markers of response to pre-operative chemotherapy and treatment-related toxicity.
Background
Pancreatic cancer is amongst the most lethal of all adult cancers. Over 2,500 Australians are diagnosed with pancreatic cancer each year. Currently, the 5-year survival rate is only 7.7% with no major improvements in survival over the past 30 years.
Pancreatic cancers diagnosed in early stages can be treated with surgery. For pancreatic cancer surgery to be considered successful and curative there must be no cancer remaining after surgery; this is often hard to achieve due to the proximity of the pancreas to vital structures. The 5–year survival rate of patients undergoing surgery is approximately 20%.
Previous research has demonstrated that a combination of gemcitabine and nab-paclitaxel significantly improves response and overall survival in patients with metastatic pancreatic cancer. Chemotherapy before surgery can also help identify patients with aggressive tumour biology, who can then avoid surgery that would provide them with little benefit. This is important as data from the New South Wales Pancreatic Cancer Network clearly demonstrated poorer survival among patients whose cancers are not completely removed by surgery.
The study is currently in the follow up stage. Initial data analysis showed that pre-operative treatment with gemcitabine and nab-paclitaxel is feasible and well-tolerated.
The researchers are still following up patients and will assess the effect of the treatment on survival. The tumour tissue provided by patients will be used, with their permission, to look for potential biomarkers that might influence patients’ prognoses.
Clinical Trial Design
The GAP trial is a non-randomised phase II study.
All participants will receive pre-operative chemotherapy with gemcitabine and nab-paclitaxel intravenously on day-1, day-8 and day-15 of a 28-day cycle. This is repeated for a total of 2 cycles before surgery and will take 8 weeks to deliver.
Participants will be assessed after surgery to determine whether all the cancerous tissue has been successfully removed. They will then be allocated to receive different post-surgical treatment depending on the outcome of the operation. If all the cancer has been removed, the patients will receive a further 4 cycles of the same chemotherapy with gemcitabine and nab-paclitaxel. If the cancer has not been completely removed during surgery, patients will receive daily radiotherapy over 5 weeks. This will be delivered concurrently with a continuous infusion of 5-fluorouracil chemotherapy for the duration of the radiotherapy. After chemoradiotherapy, patients will receive 4 cycles of adjuvant gemcitabine and nab-paclitaxel chemotherapy.
Blood tests and safety assessments will also be regularly conducted throughout the 12-month duration of the trial.
Study Chairs
Professor Andrew Barbour (Princess Alexandra Hospital, Woolloongabba QLD)
Professor David Goldstein (Prince of Wales Hospital, Randwick NSW)
Contact Email
gap@ctc.usyd.edu.auPrincipal Investigator
Professor Andrew Barbour
More Information
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.
Funding
Australasian Gastro-Intestinal Trials Group (AGITG)
Specialised Therapeutics Australia
Changing outcomes for people with gastro-intestinal cancer since 1991