Copyright ©The Author(s) 2020.
World J Gastroenterol. Aug 7, 2020; 26(29): 4218-4239
Published online Aug 7, 2020. doi: 10.3748/wjg.v26.i29.4218
Table 1 Time between completion of neoadjuvant therapy and first reassessment in watch and wait clinical studies
StudyPatients (n)Neoadyuvant therapy
Timing of assessment after CRT
Radiotherapy scheduleChemotherapy regimen
Habr-Gama et al[107], 20137054Gy/30CRT: 5-FU/LV CNCT: 5-FU/LV x310 wk
Araujo et al[128], 20155145 Gy/25 or 50, 40 Gy/28CRT: 5-FU or capecitabineNS
Smith et al[129], 20123250,4 Gy/28CRT: 5-FU or capecitabine4-10 wk
Dalton et al[127], 20121245 Gy/25CRT: capecitabine8 wk
Renehan et al[99], 201625945 Gy/25CRT: 5-FU or capecitabine≥ 8 wk
Appelt et al[5], 20155160 Gy/30 to tumor + 50 Gy/30 to LNsTegafur-uracil (UFT)6 wk
Vaccaro et al[130], 201620450.4 Gy/28CRT: 5-FU/LV8-12 wk
Lai et al[131], 201626745 Gy/25 or 54 Gy/30CRT: 5-FU/LV8-12 wk
Martens et al[98], 201614150.4 Gy/28 or 5 Gy/5CRT: 5-FU8-20 wk
Creavin et al[132],36250-54 Gy/30CRT: 5-FU6-8 wk
Table 2 Tumor regrowth and salvage surgery in watch and wait clinical studies
StudyPatients (n)RegrowthSalvage surgeryDistant metastasisSurvival
Habr-Gama et al[161]9027 (31%)93%13 (14%)3 yr (88%)
Renehan et al[99]12944 (34%)84%5 (4%)3 yr (96%)
Kong et al[162]370105 (28.4%)83.80%
van der Valk et al[102]1000250 (25%)86%80 (8%)5 yr (85%)
Chadi et al[165]602168 (28%)89%60 (10%)5 yr (87%)
Dattani et al[100]692149 (21.6%)88%56 (8.2%)3 yr (93.5%)
On et al[164]24837 (15.3%)68.40%8 (21%)92.30%
Nasir et al[160]7823 (29.5%)100%1 (4.35%)3 yr (96%)
Table 3 Selected ongoing clinicals trials in patients with rectal cancer in a watch-and-wait program identifier (NCT number)Study typeNeoadjuvant schedulePrimary outcomePlanned enrollment (n)Recruitment status
NCT03402477ObservationalRadiotherapy or chemo-radiotherapy (at least 40 Gy) or short-course radiotherapy combined with chemotherapyLocal relapse rate100Recruiting
NCT03125343InterventionalAccording to the Swedish National3-yr disease free survival200Recruiting
Non-randomizedProgram for rectal cancer
NCT03846726ObservationalNeoadjuvant chemoradiotherapyDisease free survival513Active, not recruiting
NCT03064646InterventionalNeoadjuvant chemoradiotherapy or neoadjuvant radiotherapy associated or not with induction chemotherapyLocal relapse rate30Recruiting
NCT03426397ObservationalShort course of radiation or neoadjuvant chemoradiotherapy2-yr non-regrowth disease free survival220Recruiting
NCT04009876Interventional5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 wk)Clinical complete response rate30Recruiting
NCT03001362Interventional54 Gy in 30fx with radiosensitizing chemotherapy as per institutional standardLocal relapse rate48Recruiting
NCT02704520InterventionalExperimental arm: 45Gy-55Gy long course radiotherapy with radiosensitizing chemotherapy as per institutional standardFeasibility phase: To assess the rate of patient recruitment98Recruiting
Phase III trial: 3-years disease free suvival
NCT04095299InterventionalExperimental arm: 62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume with capecitabine2-yr rectal preservation111Recruiting