. 2020 Aug 7;26(29):4218–4239. doi: 10.3748/wjg.v26.i29.4218

Table 3.

Selected ongoing clinicals trials in patients with rectal cancer in a watch-and-wait program

Clinicaltrials.gov identifier (NCT number)	Study type	Neoadjuvant schedule	Primary outcome	Planned enrollment (n)	Recruitment status
NCT03402477	Observational	Radiotherapy or chemo-radiotherapy (at least 40 Gy) or short-course radiotherapy combined with chemotherapy	Local relapse rate	100	Recruiting
NCT03402477	Prospective		Local relapse rate	100	Recruiting
NCT03125343	Interventional	According to the Swedish National	3-yr disease free survival	200	Recruiting
NCT03125343	Non-randomized	Program for rectal cancer	3-yr disease free survival	200	Recruiting
NCT03846726	Observational	Neoadjuvant chemoradiotherapy	Disease free survival	513	Active, not recruiting
NCT03846726	Retrospective	Neoadjuvant chemoradiotherapy	Disease free survival	513	Active, not recruiting
NCT03064646	Interventional	Neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy associated or not with induction chemotherapy	Local relapse rate	30	Recruiting
NCT03064646	Non-randomized		Local relapse rate	30	Recruiting
NCT03426397	Observational	Short course of radiation or neoadjuvant chemoradiotherapy	2-yr non-regrowth disease free survival	220	Recruiting
NCT03426397	Prospective	Short course of radiation or neoadjuvant chemoradiotherapy	2-yr non-regrowth disease free survival	220	Recruiting
NCT04009876	Interventional	5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 wk)	Clinical complete response rate	30	Recruiting
NCT04009876	Non-randomized		Clinical complete response rate	30	Recruiting
NCT03001362	Interventional	54 Gy in 30fx with radiosensitizing chemotherapy as per institutional standard	Local relapse rate	48	Recruiting
NCT03001362	Non-randomized		Local relapse rate	48	Recruiting
NCT02704520	Interventional	Experimental arm: 45Gy-55Gy long course radiotherapy with radiosensitizing chemotherapy as per institutional standard	Feasibility phase: To assess the rate of patient recruitment	98	Recruiting
	Randomized
	Randomized		Phase III trial: 3-years disease free suvival
NCT04095299	Interventional	Experimental arm: 62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume with capecitabine	2-yr rectal preservation	111	Recruiting
NCT04095299	Randomized		2-yr rectal preservation	111	Recruiting

An advanced search of ClinicalTrials.gov was performed in March 2020 for “wath and wait in rectal cancer” (retrieved 10 records). These were reviewed and selected based on the status of the study. nal-IRI: Liposomal irinotecan; 5-FU: 5-fluorouracil; LV: Leucovorin.