Clinical trial NCT04095468: Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
Official title: Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Neoplasms
Rectal Cancer
Keywords: rectal cancer
preoperative radiotherapy
organ preservation
watch-and-wait
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Polish Society of Surgical Oncology
First posted: 2019-09-19
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 140 patients with "resectable" cancer and 75 patients with threatened mesorectal fascia as assessed on multidisciplinary tumor board.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Primary rectal cancer
* Low tumour (accessible by digital rectal examination)
* Routine preoperative radio(chemo)therapy according to the institutional policy; short-course radiation and immediate surgery is not allowed.
* Informed consent for watch-and-wait strategy or local excision in patients with cCR and near-cCR

Exclusion Criteria:

* Recurrent cancer
* Cancers situated in the upper rectum
* Distant metastases

Primary outcomes:
measure: Percentages of cCR and near-cCR in the patients with "resectable" cancer
timeFrame: 11 weeks from the start of radiotherapy
measure: Percentages of cCR and near-cCR in the patients with threatened mesorectal fascia.
timeFrame: 11 weeks from the start of radiotherapy
measure: Percentages of cCR and near-cCR in relation to the selected tumour characteristics.
timeFrame: 11 weeks from the start of radiotherapy
measure: Percentages of pCR in the patients after total mesorectal excision performed because of tumour persistence.
timeFrame: 12 weeks from the start of radiotherapy
Secondary outcomes:
measure: Local regrowth rate
timeFrame: 5 years
measure: Disease-free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 5 years
measure: Anorectal function assessed by low anterior resection syndrome (LARS) score
timeFrame: 3 years
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Maria Skłodowska-Curie Institute - Oncology Center
state: Mazovian
city: Bydgoszcz
country: Poland
facility: Collegium Medicum Nicolaus Copernicus University and Oncology Centre
city: Kielce
country: Poland
facility: Regional Oncological Centre
city: Kraków
country: Poland
facility: Jagiellonian Medical University College
city: Lublin
country: Poland
facility: St. John's Cancer Center
city: Wrocław
country: Poland
facility: Silesian Oncological Centre
city: Zamość
country: Poland
facility: NU-MED Centre for Cancer Diagnosis and Treatment
Study officials:
References: