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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maria Sklodowska-Curie National Research Institute of Oncology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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