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

Recruiting

• Conditions: Rectal Neoplasms; Rectal Cancer
• Interventions: Radiation: Preoperative Radio(Chemo)Therapy

• Registration Number: NCT04095468
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-18
• Status Verified: 2019-09
• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-17
• Last Update Submitted: 2019-09-17
• Study First Posted: 2019-09-19
• Last Update Posted: 2019-09-19
• Primary Completion: 2021-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 215

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Resectable rectal cancer	Preoperative Radio(Chemo)Therapy	-
Rectal cancer with threatened mesorectal fascia	Preoperative Radio(Chemo)Therapy	-

Primary Outcome Measures

Name	Time	Method
Percentages of cCR and near-cCR in the patients with "resectable" cancer	11 weeks from the start of radiotherapy
Percentages of cCR and near-cCR in the patients with threatened mesorectal fascia.	11 weeks from the start of radiotherapy
Percentages of cCR and near-cCR in relation to the selected tumour characteristics.	11 weeks from the start of radiotherapy	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).
Percentages of pCR in the patients after total mesorectal excision performed because of tumour persistence.	12 weeks from the start of radiotherapy

Secondary Outcome Measures

Name	Time	Method
Local regrowth rate	5 years
Disease-free survival	3 years
Overall survival	5 years
Anorectal function assessed by low anterior resection syndrome (LARS) score	3 years	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).

Trial Locations

Locations (7)

Collegium Medicum Nicolaus Copernicus University and Oncology Centre; 🇵🇱 Bydgoszcz, Poland

Silesian Oncological Centre; 🇵🇱 Wrocław, Poland

NU-MED Centre for Cancer Diagnosis and Treatment; 🇵🇱 Zamość, Poland

Jagiellonian Medical University College; 🇵🇱 Kraków, Poland

St. John's Cancer Center; 🇵🇱 Lublin, Poland

Maria Skłodowska-Curie Institute - Oncology Center; 🇵🇱 Warsaw, Mazovian, Poland

Regional Oncological Centre; 🇵🇱 Kielce, Poland