Table 2.

Ongoing Trials for Non-Operative Management of Rectal Cancer.

Trial Number (NCT)	Location	Study Arm 1	Study Arm 2	Primary Outcome(s)	Secondary Outcome(s)	Estimated Enrollment	Status
02008656	USA	8c FOLFOX or 5c CapeOX followed by CRT	CRT followed by 6c CapeOX or 8c FOLFOX	3-yr DFS	Adverse events	325	Recruiting
02514278	France	4c Folfirinox then CRT	CRT alone	Rate of organ presevation and absence of stoma	Several, including, OS, DFS*	218	Recruiting
02704520	UK	Surgery followed by CapeOX or FOLFOX or single agent 5-Fu	CRT then chemotherapy followed by observation or surgery ^	Patient recruitment rate	Several including, drug toxicity, surgical morbidity*	90	Recruiting
01047969	UK	CRT followed by chemo if cCR	CRT followed by surgery	Rate of NOM; 2-yr LF	Several including positive margin rate, OS	99	Unknown
03426397	The Nether-lands	Multicenter prospective observational cohort study including patients with rectal cancer who after a long course of CRT or a short course of radiation with a long waiting interval have a clinical complete response (ycT0N0).		2-year non-regrowth rate and DFS	Several including LC, OS	220	Recruiting

Abbreviations: USA, United States of America; UK, United Kingdom; c, cyles; FOLFOX, folinic acid, 5-fluorouracil, and oxaliplatin; CapeOx, capecitabine and oxaliplatin; CRT, chemotherapy with concurrent radiotherapy; Folfirinox, 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin; 5-Fu, 5-fluorouracil; DFS, disease-free survival; NOM, non-operative management; LF, local-failure.

^depending on response to neoadjuvant therapy

* For complete list of secondary outcome measures, please refer to http://clinicaltrials.gov.