Rectal CancerNCT01863862
Organ Preservation in Elderly Patients With Rectal Cancer
A study testing Radiochemotherapy or radiotherapy in people with Rectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
In elderly patients postoperative mortality measured 3-6 months after total mesorectal excision is high. Thus, less toxic treatments may lead to a survival benefit for elderly patients even if a risk of local recurrence is slightly higher compared to the open surgery. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Radiochemotherapy or radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2012to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The initial eligibility criteria
- Age ≥70 years or <70 years in patients with ASA 3+
- Tumour accessible by digital rectal examination
- Maximal tumour size (usually length) not more than 5 cm
- Circumferential bowel wall involvement not larger than 60%
- There will be two groups of patients:
Show all 10Show fewer
- Candidates for preoperative (chemo)radiotherapy and local excision: tumour ≤3 cm, non-polipoid cT1, or cT2 or borderline cT3, cN0.
- Candidates for preoperative (chemo)radiotherapy and total mesorectal excision: cT2 tumors requiring abdominoperineal excision, or cT3 or resectable cT4 (slight involvement of vagina, prostate or seminal vesicles); cN+ is allowed.
- The final eligibility criterion
- Complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation
Who cannot join
- Distant metastases
- Fixed tumour on digital rectal examination
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
M. Sklodowska-Curie Memorial Cancer Center
Warsaw, 02-781
Krzysztof Bujko, Prof., +48 601207466, bujko@coi.waw.pl
Krzysztof Bujko, Prof.
About this study
Official title: Organ Preservation in Elderly Patients With Rectal Cancer: a Prospective Observational Study
In elderly patients postoperative mortality measured 3-6 months after total mesorectal excision is high. Thus, less toxic treatments may lead to a survival benefit for elderly patients even if a risk of local recurrence is slightly higher compared to the open surgery. The investigators addressed the question whether watch and wait policy is safe in clinical complete responders after (chemo)radiation for elderly patients with small or moderately advanced tumours.
Read the detailed description
There are two steps of selection. In the first step, the elderly patients with small or moderately advanced tumours who should routinely receive neoadjuvant chemoradiation (or radiation alone in those unfit for chemotherapy) prior to full-thickness local excision using transanal endoscopic microsurgery or prior to total mesorectal excision will be included. In the next step, only patients with clinical complete response obtained 8-10 weeks from completion of (chemo)radiation are selected. Those patients constitute study group and will be observed without further treatment. The remaining patients with residual cancer will proceed to routine management, namely transanal endoscopic microsurgery or total mesorectal excision. Patients undergoing transanal endoscopic microsurgery and having poor response to (chemo)radiation (ypT2-3 disease or positive margin) will proceed to the conversion to total mesorectal excision.
Neoadjuvant chemoradiation: 50 Gy total dose over 5 weeks with 2 Gy per fraction delivered with simultaneous chemotherapy consisting of three cycles of 5-Fu 200 mg/m2 i.v. bolus and leucovorin 100 mg/m2 i.v. short infusion over 2 days given during 1-2, 15-16, and 29-30 days of radiotherapy. Patients unfit for chemotherapy will receive 25 Gy total dose over 5 days with 5 Gy per fraction.
The study hypothesis is that in clinical complete responders after (chemo)radiation treated without initial surgery, the local recurrence rate will be less than 25% and results of the rescue surgery (local and distant recurrence rate) will be not worse (or only slightly worse) than that seen after up-front total mesorectal excision in patients with similar stage of the disease.
- Conditions
- Rectal Cancer
- Being tested
- Radiochemotherapy or radiotherapy
- Keywords
- Rectal cancer, Chemoradiation, Complete pathological response
- Medical subject headings
- Rectal Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiochemotherapy or radiotherapyRadiation
50 Gy, 2 Gy per fraction with simultaneous 5-Fu and leucovorin or 5 x 5 Gy for patients unfit for chemotherapy.
Patients with complete clinical response 8-10 weeks after radiotherapy will be closely observed and rescue surgery will be performed in a case of local recurrence.
Patients with persistent tumour 8-10 weeks after radiotherapy will undergo transanal endoscopic microsurgery or total mesorectal excision. After transanal endosciopic microsurgery, patients with ypT0-1 disease and negative surgical margins will be closely observed and rescue total mesorectal excision will be performed in a case of local recurrence; those with ypT2-3 disease or with positive margin will undergo immediate conversion to total mesorectal excision.
| Study group | Role | What they receive |
|---|---|---|
| Clinical complete responders. | Experimental | Patients with complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation. Receives: Radiation: Radiochemotherapy or radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The final three-year rate of local and distant recurrences taking into consideration results of rescue surgery for pelvic recurrence.
Measured: After 3 years of median follow-up for living patients.
Secondary outcomes (7)
The rate of local recurrence at one year without taking into consideration results of rescue surgery.
Measured: up to 20 months
The rate of local and distant recurrences after rescue surgery of pelvic recurrence.
Measured: After 3 years of median follow-up for living patients.
Overall survival at three years.
Measured: After 3 years of median follow-up for living patients.
Disease-free survival at three years
Measured: After 3 years of median follow-up for living patients.
Cancer specific survival at three years.
Measured: After 3 years of median follow-up for living patients.
Evaluation of anorectal function by using self-administered questionnaire in patients without local recurrence.
Measured: 1 year after treatment
Multivariable analysis of prognostic factors associated with clinical complete response.
Measured: After 3 years of median follow-up for living patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startAug 2012
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krzysztof Bujko, Prof., Principal investigator, M. Sklodowska-Curie memorial Cancer Centre in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863862
- Sponsor's protocol ID
- PGBRJG0113
- Status last verified
- Mar 2019
- First submitted
- 14 May 2013
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Preservation in Elderly Patients With Rectal Cancer: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01863862
- Acronym / sponsor ID
- PGBRJG0113
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Chemoradiation, Complete pathological response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In elderly patients postoperative mortality measured 3-6 months after total mesorectal excision is high. Thus, less toxic treatments may lead to a survival benefit for elderly patients even if a risk of local recurrence is slightly higher compared to the open surgery. The investigators addressed the question whether watch and wait policy is safe in clinical complete responders after (chemo)radiation for elderly patients with small or moderately advanced tumours.
Detailed description
There are two steps of selection. In the first step, the elderly patients with small or moderately advanced tumours who should routinely receive neoadjuvant chemoradiation (or radiation alone in those unfit for chemotherapy) prior to full-thickness local excision using transanal endoscopic microsurgery or prior to total mesorectal excision will be included. In the next step, only patients with clinical complete response obtained 8-10 weeks from completion of (chemo)radiation are selected. Those patients constitute study group and will be observed without further treatment. The remaining patients with residual cancer will proceed to routine management, namely transanal endoscopic microsurgery or total mesorectal excision. Patients undergoing transanal endoscopic microsurgery and having poor response to (chemo)radiation (ypT2-3 disease or positive margin) will proceed to the conversion to total mesorectal excision.
Neoadjuvant chemoradiation: 50 Gy total dose over 5 weeks with 2 Gy per fraction delivered with simultaneous chemotherapy consisting of three cycles of 5-Fu 200 mg/m2 i.v. bolus and leucovorin 100 mg/m2 i.v. short infusion over 2 days given during 1-2, 15-16, and 29-30 days of radiotherapy. Patients unfit for chemotherapy will receive 25 Gy total dose over 5 days with 5 Gy per fraction.
The study hypothesis is that in clinical complete responders after (chemo)radiation treated without initial surgery, the local recurrence rate will be less than 25% and results of the rescue surgery (local and distant recurrence rate) will be not worse (or only slightly worse) than that seen after up-front total mesorectal excision in patients with similar stage of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical complete responders. | Experimental | Radiation: Radiochemotherapy or radiotherapyPatients with complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- The initial eligibility criteria
- Age ≥70 years or <70 years in patients with ASA 3+
- Tumour accessible by digital rectal examination
- Maximal tumour size (usually length) not more than 5 cm
- Circumferential bowel wall involvement not larger than 60%
Key exclusion criteria (2 listed)
- Distant metastases
- Fixed tumour on digital rectal examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiochemotherapy or radiotherapy50 Gy, 2 Gy per fraction with simultaneous 5-Fu and leucovorin or 5 x 5 Gy for patients unfit for chemotherapy. Patients with complete clinical response 8-10 weeks after radiotherapy will be closely observed and rescue surgery will be performed in a case of local recurrence. Patients with persistent tumour 8-10 weeks after radiotherapy will undergo transanal endoscopic microsurgery or total mesorectal excision. After transanal endosciopic microsurgery, patients with ypT0-1 disease and negative surgical margins will be closely observed and rescue total mesorectal excision will be performed in a case of local recurrence; those with ypT2-3 disease or with positive margin will undergo immediate conversion to total mesorectal excision. | Radiation | Clinical complete responders. |
Primary outcome
The final three-year rate of local and distant recurrences taking into consideration results of rescue surgery for pelvic recurrence.
Time frame: After 3 years of median follow-up for living patients.
7 secondary outcomes
The rate of local recurrence at one year without taking into consideration results of rescue surgery.
Time frame: up to 20 months
The rate of local and distant recurrences after rescue surgery of pelvic recurrence.
Time frame: After 3 years of median follow-up for living patients.
Overall survival at three years.
Time frame: After 3 years of median follow-up for living patients.
Disease-free survival at three years
Time frame: After 3 years of median follow-up for living patients.
Cancer specific survival at three years.
Time frame: After 3 years of median follow-up for living patients.
Evaluation of anorectal function by using self-administered questionnaire in patients without local recurrence.
Time frame: 1 year after treatment
Multivariable analysis of prognostic factors associated with clinical complete response.
Time frame: After 3 years of median follow-up for living patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Bujko, Prof. principal investigator
M. Sklodowska-Curie memorial Cancer Centre in Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiochemotherapy or radiotherapy in people with Rectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krzysztof Bujko, Prof. (+48 601207466, bujko@coi.waw.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The final three-year rate of local and distant recurrences taking into consideration results of rescue surgery for pelvic recurrence. (time frame: After 3 years of median follow-up for living patients.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.