Background: Early phase clinical trials for children with incurable cancers can benefit from early pediatric palliative approach. The investigation center not only handles the trial but also takes care of all the symptomatic treatments. In this context, it seems difficult for the investigator to address issues around failing health and death, making the use of a palliative care team pivotal to discuss these questions. The purpose of this study is to evaluate relevance of a pediatric palliative approach for these patients.

Materials & methods: We have analyzed the resorting to palliative care teams for 17 children included in a phase II clinical trial as pilot project before going for a full-fledged study. Pediatric palliative care team had visited individual patients to evaluate their needs and do the needful as appropriate. 

Results: It was found that 11 patients need additional support from the pediatric palliative care team and would benefit from a long-term care. The team had taken care of the symptomatic management, and this had reduced the workload of the trial investigator to a great extent. 

Conclusion: It is feasible and crucial to include a pediatric palliative approach in early phase clinical trials as the end results are largely uncertain and most patients would benefit from this approach. This also enabled clinical trial investigator to focus on trial without being entangled and overwhelmed with symptom management.