LAP07 Study

A randomised multicentre  phase  III  study  in  patients  with  locally advanced adenocarcinoma of the pancreas; gemcitabine with or without chemoradiotherapy and with or without erlotinib.

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Trial Status

Completed

Cancer Type

Pancreatic Cancer

Aim

This study will examine many of the key clinical questions for patients with LA pancreatic cancer. It will test whether the addition of radiotherapy to standard chemotherapy will increase survival. The primary aim of this study is to determine the role of radiotherapy in patients with locally advanced pancreatic cancer. Secondary aims are to evaluate the efficacy and safety of erlotinib.

Summary

Adenocarcinoma of the pancreas represents 2% of all cancers and 10 % of gastrointestinal cancers. Approximately 15-20% of patients presents with early disease and are able to undergo curative resection. Forty percent present with advanced loco regional disease precluding complete resection with a median survival time of 9 – 12 months. The available therapeutic options for patients with locally advanced pancreatic cancer (LAP) are systemic chemotherapy (CT) or chemoradiotherapy (CRT) but the choice of one or other of these regimens remains controversial with conflicting results reported in the literature. The identification of an effective treatment that can achieve durable symptom control remains a high priority for these patients.

Sub-studies: Three AGITG sub-studies have been included:

Radiotherapy Quality Assurance – ensuring uniform delivery of trial standard radiotherapy to patients at all sites;

Surgical – examining surgical interventions for both curative purposes and management of symptoms; and

Biological – utilizing tissue collected for the testing of bio-markers to predict the response of LAP patients to treatment regimens.

Trial Status

Completed

Cancer Type

Pancreatic Cancer

Publication Reference

Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C. Effect of chemoradiotherapy vs chemotherapy on survival in patients with locally advanced pancreatic cancer controlled after 4 months of gemcitabine with or without erlotinib: the LAP07 randomized clinical trial. JAMA 2016; 315(17): 1844–1853.

Conference Presentation Reference

  1. Huguet F, Hammel P, Vernerey D, Goldstein D, Van Laethem JL, Glimelius B, Spry N, S Paget-Bailly, Bonnetain F, Louvet C. Impact of chemoradiotherapy on local control and time without treatment in patients with locally advanced pancreatic cancer included in the international phase III LAP 07 study. American Society of Clinical Oncology 50th Annual Meeting; 30 May–3 Jun 2014; Chicago.
  2. Ricadot S, Hammel P, Chibaudel B, Goldstein D, Spry N, Van Laethem J, Van Houtte P, Glimelius B, Gubanski M, Huguet F. Dummy run in the phase III LAP07 pancreatic cancer trial: First evaluation of quality of radiation therapy planning. American Society for Radiation Oncology 54th Annual Meeting; 28–31 Oct 2014; San Francisco.
  3. Hammel P, Huguet F, Van Laethem J, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, André T, Mineur L, Chibaudel B, Bonnetain F, Louvet C. Comparison of chemoradiotherapy and chemotherapy in patients with a locally advanced pancreatic cancer controlled after 4 months of gemcitabine with or without erlotinib: final results of the international phase III LAP 07 study. American Society of Clinical Oncology Annual Meeting; 31 May–4 Jun 2013; Chicago. Journal of Clinical Oncology; 31(suppl.): LBA4003.
  4. Goldstein D, Spry N, Padbury R, Kneebone A, Barbour A, Biankin A, Harris D, Wong N, Roff K, Shannon J. LAP 07: Randomized multicenter phase III study in patients with locally advanced adenocarcinoma of the pancreas: gemcitabine with or without chemoradiotherapy and with or without erlotinib. Clinical Oncological Society of Australia (COSA) Annual Scientific Meeting; 9–11 Nov 2010; Melbourne.

Aim

This study will examine many of the key clinical questions for patients with LA pancreatic cancer. It will test whether the addition of radiotherapy to standard chemotherapy will increase survival. The primary aim of this study is to determine the role of radiotherapy in patients with locally advanced pancreatic cancer. Secondary aims are to evaluate the efficacy and safety of erlotinib.

Summary

Adenocarcinoma of the pancreas represents 2% of all cancers and 10 % of gastrointestinal cancers. Approximately 15-20% of patients presents with early disease and are able to undergo curative resection. Forty percent present with advanced loco regional disease precluding complete resection with a median survival time of 9 – 12 months. The available therapeutic options for patients with locally advanced pancreatic cancer (LAP) are systemic chemotherapy (CT) or chemoradiotherapy (CRT) but the choice of one or other of these regimens remains controversial with conflicting results reported in the literature. The identification of an effective treatment that can achieve durable symptom control remains a high priority for these patients.

Sub-studies: Three AGITG sub-studies have been included:

Radiotherapy Quality Assurance – ensuring uniform delivery of trial standard radiotherapy to patients at all sites;

Surgical – examining surgical interventions for both curative purposes and management of symptoms; and

Biological – utilizing tissue collected for the testing of bio-markers to predict the response of LAP patients to treatment regimens.

Principal Investigator

Prof David Goldstein & Dr Jenny Shannon