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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04095468
Other study ID # ORGANPRESERV1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 18, 2017
Est. completion date January 1, 2026

Study information

Verified date September 2019
Source Maria Sklodowska-Curie Institute - Oncology Center
Contact Krzysztof Bujko, M.D. PhD
Phone +48601207466
Email Krzysztof.Bujko@coi.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 215
Est. completion date January 1, 2026
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Preoperative Radio(Chemo)Therapy
Preoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait

Locations

Country Name City State
Poland Collegium Medicum Nicolaus Copernicus University and Oncology Centre Bydgoszcz
Poland Regional Oncological Centre Kielce
Poland Jagiellonian Medical University College Kraków
Poland St. John's Cancer Center Lublin
Poland Maria Sklodowska-Curie Institute - Oncology Center Warsaw Mazovian
Poland Silesian Oncological Centre Wroclaw
Poland NU-MED Centre for Cancer Diagnosis and Treatment Zamosc

Sponsors (2)

Lead Sponsor Collaborator
Maria Sklodowska-Curie Institute - Oncology Center Polish Society of Surgical Oncology

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentages of cCR and near-cCR in the patients with "resectable" cancer 11 weeks from the start of radiotherapy
Primary Percentages of cCR and near-cCR in the patients with threatened mesorectal fascia. 11 weeks from the start of radiotherapy
Primary 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). 11 weeks from the start of radiotherapy
Primary Percentages of pCR in the patients after total mesorectal excision performed because of tumour persistence. 12 weeks from the start of radiotherapy
Secondary Local regrowth rate 5 years
Secondary Disease-free survival 3 years
Secondary Overall survival 5 years
Secondary 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). 3 years
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