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

NCT04095468 | Unknown

• 1 other identifier: ORGANPRESERV1
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 7

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.

Conditions

Rectal Neoplasms; Rectal Cancer

Keywords

rectal cancer; preoperative radiotherapy; organ preservation; watch-and-wait

Outcome Measures

Primary Outcomes (4)

• 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.

  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

• Percentages of pCR in the patients after total mesorectal excision performed because of tumour persistence.

  12 weeks from the start of radiotherapy

Secondary Outcomes (4)

• 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

Study Arms (2)

Resectable rectal cancer

Radiation: Preoperative Radio(Chemo)Therapy

Rectal cancer with threatened mesorectal fascia

Radiation: Preoperative Radio(Chemo)Therapy

Interventions

Preoperative Radio(Chemo)Therapy RADIATION

Preoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait

Rectal cancer with threatened mesorectal fascia; Resectable rectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• Polish Society of Surgical Oncology: collaborator

Study Sites (7)

Maria Skłodowska-Curie Institute - Oncology Center

Warsaw, Mazovian, 02-781, Poland

RECRUITING

Collegium Medicum Nicolaus Copernicus University and Oncology Centre

Bydgoszcz, Poland

RECRUITING

Regional Oncological Centre

Kielce, Poland

RECRUITING

Jagiellonian Medical University College

Krakow, Poland

NOT YET RECRUITING

St. John's Cancer Center

Lublin, Poland

RECRUITING

Silesian Oncological Centre

Wroclaw, Poland

RECRUITING

NU-MED Centre for Cancer Diagnosis and Treatment

Zamość, Poland

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Krzysztof Bujko, M.D. PhD

CONTACT

+48601207466; Krzysztof.Bujko@coi.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 19, 2019
• Study Start: September 18, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2026
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

PL (7)