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

September 17, 2019 updated by: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

215

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Bydgoszcz, Poland
        • Recruiting
        • Collegium Medicum Nicolaus Copernicus University and Oncology Centre
        • Contact:
          • Michał Jankowski, M.D.
        • Principal Investigator:
          • Michał Jankowski, M.D.
      • Kielce, Poland
        • Recruiting
        • Regional Oncological Centre
        • Contact:
          • Jacek Sadowski, M.D.
        • Principal Investigator:
          • Jacek Sadowski, M.D.
      • Kraków, Poland
        • Not yet recruiting
        • Jagiellonian Medical University College
        • Contact:
          • Piotr Richter, M.D.
        • Principal Investigator:
          • Piotr Richter, M.D.
      • Lublin, Poland
        • Recruiting
        • St. John's Cancer Center
        • Contact:
          • Małgorzata Jankiewicz, M.D.
        • Principal Investigator:
          • Małgorzata Jankiewicz, M.D.
      • Wrocław, Poland
        • Recruiting
        • Silesian Oncological Centre
        • Contact:
          • Jolanta Szelachowska, M.D.
        • Principal Investigator:
          • Jolanta Szelachowska, M.D.
      • Zamość, Poland
        • Recruiting
        • NU-MED Centre for Cancer Diagnosis and Treatment
        • Contact:
          • Marek Mazurek, M.D.
        • Principal Investigator:
          • Marek Mazurek, M.D.
    • Mazovian
      • Warsaw, Mazovian, Poland, 02-781
        • Recruiting
        • Maria Skłodowska-Curie Institute - Oncology Center
        • Contact:
        • Principal Investigator:
          • Krzysztof Bujko, M.D. PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Resectable rectal cancer
Radiation: Preoperative Radio(Chemo)Therapy
Preoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait
Rectal cancer with threatened mesorectal fascia
Radiation: Preoperative Radio(Chemo)Therapy
Preoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
5 years
Disease-free survival
Time Frame: 3 years
3 years
Local regrowth rate
Time Frame: 5 years
5 years
Anorectal function assessed by low anterior resection syndrome (LARS) score
Time Frame: 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).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborators

Polish Society of Surgical Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 18, 2017

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2026

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (ACTUAL)

September 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORGANPRESERV1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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