Table 4.

Evaluations during surveillance for WW and post-TME

a: Evaluations during follow-up for WW patients (after completion of TNT with cCR and post-TNT restaging)

Years on study

Year 1 (Every 3 months)

Year 2 (Every 3 months)

Year 3 (Every 6 months)

Years 4–5* (Every 6 months)

Months after post-TNT restaging (± 30 days)

3

6

9

12

15

18

21

24

30

36

42

48

54

60

History and Physical

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Sigmoidoscopy/Proctosigmoidoscopy

X

X

X

X

X

X

X

X

X

X

X

X

X

X

MRI Rectum

X

X

X

X

X

X

X

CT CAP1

X

X

X

X

X

CEA levels2

X

X

X

X

X

X

X

X

X

X

X

X

b: Evaluations during follow-up for TME patients (after definitive surgical resection)#

Years on study

Year 1 (Every 3 months)

Year 2 (Every 3 months)

Year 3 (Every 6 months)

Years 4–5** (Every 6 months)

Months after treatment (± 30 days)

3

6

9

12

15

18

21

24

30

36

42

48

54

60

History and Physical

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Sigmoidoscopy/Proctosigmoidoscopy**

X

X

X

X

X

CT CAP1

X

X

X

X

X

X

X

CEA levels2

X

X

X

X

X

X

X

X

X

X

X

X

X

X

^*MRI in years 4 through 5 would only be supported if clinically indicated by treating team

¹CT of the Chest, Abdomen and Pelvis if regrowth occurs and TME completed then patients will be followed as per NCCN guidelines

²After 24 months, CEA will be evaluated every 6 months up to five years, based on NCCN guidelines

^#Institutional guidelines for surveillance can be followed post-TME in accordance with NCCN guidelines or as clinically indicated per the discretion of the treating physicians

^**If TME completed via abdominoperineal resection – A FLEXIBLE SIGMOIDOSCOPY/PROCTOSIGMOIDOSCOPY IS not relevant and unnecessary to assess the anastomosis for recurrence

¹CT of the Chest, Abdomen and Pelvis: TME group patients will be followed according to NCCN guidelines

²After 24 months, CEA will be evaluated every 6 months up to five years, based on NCCN guidelines