Table 1 Overview of applied TwiCs studies within the oncological setting
From: The Trial within Cohorts (TwiCs) study design in oncology: experience and methodological reflections
Trial | Description | Status | Planned number of patients |
|---|---|---|---|
Feasibility trial of an investigational medicinal product to treat mesothelioma. The aim of this study was to answer whether a full-scale version of the trial is possible and whether a TwiCs study is appropriate for mesothelioma trials. The investigational product is called OK-432 (“dead” bacteria) which is used to stimulate immune cells to attack the mesothelioma. The trial was initiated within the ASSESS-meso cohort [26] | Completed | 45 patients | |
Randomized controlled trial for pre-operative dose-escalation BOOST in locally advanced rectal cancer. The trial was originally initiated within the prospective data collection initiative on colorectal cancer (PICNIC) cohort, which has been renamed to PLCRC [9, 10] | Completed | 120 patients | |
HONEY [30] | Clinical trial of assessing the effect of hyperbaric oxygen therapy in breast cancer patients with late radiation toxicity. The trial is initiated within the UMBRELLA cohort [11] | Ongoing | 120 patients |
Clinical trial investigating the effect of an exercise program on the quality of life of patients with breast cancer. The trial was initiated within the UMBRELLA cohort [11] | Completed | 192 patients | |
MEDOCC-CrEATE [32] | Clinical trial investigating the effect of circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer. The presence of circulating tumor DNA is only assessed in the alternative treatment group. The trial is initiated within the PLCRC [9, 10] | Ongoing | 60 patients with circulating tumor DNA. In total, 1320 patients |
Clinical trial investigating the impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer. The trial is initiated within the PLCRC [9, 10] and is a follow-up trial of the RECTAL BOOST trial. Patients of the RECTAL BOOST trial were also eligible for the SPONGE trial | Completed | 196 patients | |
Clinical trial comparing conventional radiotherapy with stereotactic body radiotherapy in patients with spinal metastases. The trial is initiated within the prospective evaluation of interventional studies on bone metastases (PRESENT) cohort [39] | Completed | 110 patients |