Clinical trials in lung cancer surgery and research cooperation

With China having an increasingly huge burden of lung cancers, the number of Chinese studies was the second largest all over the world.

We used the advanced search option available on the ClinicalTrials.gov to review clinical trials regarding surgical issues. In the drop down menus, we chose "all studies" for recruitment status and "interventional" for study type and all trials reported until Aug, 2013 on the website were included.

Clinical trials on lung cancer surgeries (658 records) mainly aim at surgical procedures and (neo)adjuvant clinical studies, among which phase III trials account for 15.5%. Only 34.9% (230 records) trials were completed, and 43 studies presented their results on ClinicalTrials.gov. The median time to completion (MTC) of phase III surgical procedure trials is 9.4 years. The MTCs of phase III neo-adjuvant and adjuvant trials have not been reached, but definitely are longer than 10 years. In comparison, the MTC of phase III trials in the first-line treatment are only 4.3 years.

We summarized the characteristics of these trials using real-world case examples. Our analyses reveal that it is critically needed for regulatory authorities, clinical trial sponsors, collaborative research groups, and academic institutions to work together to build up the infrastructure and research cooperation for clinical trials with a surgical component. In 2007, a national collaborative clinical research group, Chinese Thoracic Oncology Group (CTONG), was established. CTONG is a network of researchers, physicians and health-care professionals in public institutions throughout China and currently has a growing membership of 25 hospitals. A CTONG-sponsored trial (CTONG1104) is discussed to illustrate our experience in surgical clinical trials. In summary, it is imperative for investigators to collaborate in cooperative clinical trials in order to expedite applications of therapies from clinical researches to cancer treatment. Since cancer treatment is multidisciplinary, current surgical trials should have multiple treatment combinations while retaining a surgical focus, and be carried out systematically with the cooperation of extensive monitoring and coordinating systems.