Exclusion of Gastrointestinal Cancer Patients With Prior Cancer From Clinical Trials: Is This Justified?

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Eligibility criteria for clinical trials are important for maintaining patient safety and scientifically valid results. Patients are commonly excluded from trials due to a history of a previous cancer. We demonstrate that patients with a previous cancer have similar survival to those who do not, and that this is not a justifiable reason to exclude them from clinical trial participation.


Strict eligibility criteria are necessary to maintain patient safety and scientific validity in clinical trials. However, this may lead to impaired generalizability of results. As survival in gastrointestinal (GI) cancer relates mainly to the GI malignancy, we hypothesized that previous cancers do not impact on survival and are not a rational exclusion criterion.

Materials and Methods:

Patients treated with chemotherapy for a GI cancer in 2006 were identified from the electronic patient record at the Royal Marsden Hospital, London. Chart review was performed and patient age, gender, GI cancer stage, prior cancer stage, clinical trial availability/eligibility, and dates of cancer recurrence, death, and last follow-up were collated.


A total of 697 patients were identified. Fifty-four patients (8%) had a prior cancer; commonly breast (26%), prostate (17%), or colon (9%); most were stage I (42%) or II (37%). Two hundred ninety-seven (65%) patients had GI cancer recurrence, 7 (12%) patients had relapse of a prior cancer. Five hundred four (72%) patients have died, 170 (24%) are alive with no cancer, and 23 (3%) patients are alive with cancer. A total of 476 (94%) died of GI cancer, 2 (0.3%) of their prior cancer. Of all patients, 489 (70%) had an available trial, but 30% of patients with a prior cancer were ineligible for this reason. Overall and GI–cancer-specific survival were comparable for patients with/without a prior cancer.


Survival for patients with a GI cancer requiring chemotherapy relates to the GI cancer and rarely a prior cancer. These patients should not be excluded from clinical trial participation.

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