Watch-and-wait strategy in rectal cancer is gaining momentum. There is a large variability in reporting the proportion of patients achieving clinical complete response (cCR) after routinely delivered preoperative radio(chemo)therapy, likely because of patients' selection. This proportion in population-based level is poorly defined. In addition, predictive factors for cCR are also poorly defined. It is known that cCR response is observed often in small tumours. However, cCR proportion in large cancers has not been sufficiently evaluated. For example, even though pathological complete response (pCR) does occur in large fixed cancer, it is unknown whether cCR does also occur because persistent fibrous stroma may mimic residual cancer in all of such cases. This is a prospective observational population-based cohort study on low rectal cancer to answer the question of how often clinical or near-clinical tumour response occur after routinely delivered preoperative radiotherapy in relation to the pre-treatment tumour characteristics. The additional question was how often pCR occur in relation to the pre-treatment tumour characteristics in the patients managed by total mesorectal excision because of persistent tumour after radiotherapy. The additional aim was the implementation of watch-and-wait strategy or full-thickness local excision (as an option instead of total mesorectal excision in the patients with sustained near-cCR) within a frame of a prospective study. In the patients managed by organ preservation, the secondary outcome measures were: i) local regrowth rate, ii) effectiveness of salvage surgery, iii) disease-free survival at 3 years and overall survival at 5 years, iv) anorectal function.
Study Type
OBSERVATIONAL
Enrollment
215
Preoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait
Maria Skłodowska-Curie Institute - Oncology Center
Warsaw, Mazovian, Poland
RECRUITINGCollegium Medicum Nicolaus Copernicus University and Oncology Centre
Bydgoszcz, Poland
RECRUITINGRegional Oncological Centre
Kielce, Poland
RECRUITINGJagiellonian Medical University College
Krakow, Poland
NOT_YET_RECRUITINGSt. John's Cancer Center
Lublin, Poland
RECRUITINGSilesian Oncological Centre
Wroclaw, Poland
RECRUITINGNU-MED Centre for Cancer Diagnosis and Treatment
Zamość, Poland
RECRUITINGPercentages of cCR and near-cCR in the patients with "resectable" cancer
Time frame: 11 weeks from the start of radiotherapy
Percentages of cCR and near-cCR in the patients with threatened mesorectal fascia.
Time frame: 11 weeks from the start of radiotherapy
Percentages of cCR and near-cCR in relation to the selected tumour characteristics.
The selected tumour characteristics: TN categories, tumour length, degree of circumferential involvement, tumour mobility on digital rectal examination (mobile, tethered, fixed) and status of mesorectal fascia (threatened or not).
Time frame: 11 weeks from the start of radiotherapy
Percentages of pCR in the patients after total mesorectal excision performed because of tumour persistence.
Time frame: 12 weeks from the start of radiotherapy
Local regrowth rate
Time frame: 5 years
Disease-free survival
Time frame: 3 years
Overall survival
Time frame: 5 years
Anorectal function assessed by low anterior resection syndrome (LARS) score
The questionnaire will be completed by patients. It includes 5 items related to anorectal function. The range of the score (0-42) is divided into 0 to 20 (no LARS), 21 to 29 (minor LARS) and 30 to 42 (major LARS).
Time frame: 3 years
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