Analysis

Operating to remove recurrent colorectal cancer: have we got it right?

BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2085 (Published 13 May 2014) Cite this as: BMJ 2014;348:g2085
  1. Tom Treasure, professor1,
  2. Kathryn Monson, researcher2,
  3. Francesca Fiorentino, research fellow3,
  4. Christopher Russell, surgeon4
  1. 1University College London Clinical Operational Research Unit, London, UK
  2. 2Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Falmer, UK
  3. 3Imperial College, Cardiothoracic Surgery Department, London, UK
  4. 4London, UK
  1. Correspondence to: T Treasure tom.treasure{at}gmail.com

A randomised controlled trial that remained unpublished for 20 years casts doubt on the survival benefit of further surgery after curative resection of colorectal cancer. Tom Treasure and colleagues tell the story of the first trial restored under the restoring invisible and abandoned trials initiative and discuss what it means today

Old, unpublished clinical trials ordinarily remain unpublished, their results unable to add to the scientific knowledge base, their implications unable to affect practice. But the new restoring invisible and abandoned trials (RIAT) initiative offers a way forward. The RIAT concept allows third parties to publish previously unpublished trials when the original trialists or sponsors fail to do so.1 Last June, the editors of BMJ and PLoS Medicine called on “researchers and editors to help restore invisible and abandoned trials” by taking unpublished study results and submitting them for publication.2 We were among the first to register our intent to RIAT3 and have now published a two decade old trial that examined the use of carcinoembryonic antigen (CEA) to prompt “second look” surgery in colorectal cancer.4

Role of CEA and second look surgery

In modern management, a newly diagnosed colorectal cancer is staged, graded, and discussed by a team of surgeons, oncologists, and radiologists with a view to curative surgery if possible. About 16% of patients operated on will have recurrence of cancer within five years.5 Monitoring with the tumour marker CEA is recommended to identify these people as early as possible. The UK’s National Institute of Health and Care Excellence recommends CEA tests at least every six months in the first three years plus a minimum of two computed tomograms of the chest, abdomen, and pelvis.6 If CEA level is raised and metastases are detected in the liver or lungs, patients are assessed for surgery to remove the metastases with …

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