Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04095468
• Other study ID #: ORGANPRESERV1
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

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