LOCALLY ADVANCED RECTAL CANCERPRONARNCT03064646
Organ Preservation in Locally Advanced Rectal Cancer
A study testing Organ Preservation in people with LOCALLY ADVANCED RECTAL CANCER, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial summary
PRONAR trial aims to assess if treatment with organ preservation in stage II and III rectal cancer after a complete or almost complete response to neoadjuvant treatment is feasible and safe in our environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LOCALLY ADVANCED RECTAL CANCER
- What is being tested?
- Organ Preservation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2017to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed histopathological diagnosis of rectal adenocarcinoma.
- Patients treated with neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy associated or not with induction chemotherapy.
- Patients with evidence of complete or near complete response criteria after completion of neoadjuvant treatment (approximately 8 weeks later). Response criteria should be based on digital rectal examination, flexible rectoscopy and MRI.
Who cannot join
- Evidence of distant metastases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
Javier Gallego, PhD, +34966616250, j.gallegoplazas@gmail.com
Silvia Fernández, MS, +966616250, silviafernandezf@gmail.com
About this study
Official title: ORGAN PRESERVATION AFTER NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED RECTAL CANCER
PRONAR trial aims to assess if treatment with organ preservation in stage II and III rectal cancer after a complete or almost complete response to neoadjuvant treatment is feasible and safe in our environment.
The main objective of this project is to implement the organ preservation strategy in the treatment of rectal cancer in our environment within a clinical study that allows the analysis of its results in terms of survival.
The secondary objective is to assess local relapse, distant relapse and quality of life.
Read the detailed description
After pathology confirmed rectal cancer patients with stage II and III (MRI, CT and endoscopy) will be identified in the first visit to Medical Oncology Department. Patients will receive the most appropriate neoadjuvant treatment according to clinical guidelines.
Response to neoadjuvant treatment will be assessed by MRI. Those patients with a complete response in MRI, confirmed by endoscopy, will be offered a "watch and wait" strategy. Patients with a complete response in MRI, with an almost complete response in endoscopy, will be offered transanal endoscopic microsurgery. All patients with complete or near complete response will sign an informed consent before study entry.
Radical surgery will be performed in patients without complete or almost complete response criteria after neoadjuvant treatment.
Patients in organ preserving strategy will be subjected to a more intensive follow up schedule, including MRI and endoscopy, compared to patients with radical surgery.
As the complete histopathologic response rate after neoadjuvant treatment in locally advanced rectal cancer is approximately 15-20%, considering that approximately 40 patients with locally advanced rectal cancer are diagnosed annually in our setting, approximately 6-8 patients per year could be potentially recruited for this project, until reaching an initial sample of 30 patients for evaluation.
The following results will be analyzed:
- Percentage of complete and almost complete responses.
- Percentage of watch and wait and transanal endoscopic microsurgery.
- Disease free survival.
- Overall survival.
- Local relapse rate.
- Distant relapse rate.
- Treatment and outcomes of relapses.
- Colostomy free survival.
- Quality of life.
All data will be obtained from patient's medical records
- Conditions
- LOCALLY ADVANCED RECTAL CANCER
- Being tested
- Organ Preservation
- Keywords
- ORGAN PRESERVATION, WATCH AND WAIT, TRANSANAL ENDOSCOPIC MICROSURGERY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organ PreservationOther
Also called Transanal Endoscopic Microsurgery, Watch and Wait
Patients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy
| Study group | Role | What they receive |
|---|---|---|
| Organ Preservation | Experimental | The experimental strategy is the omission of radical surgery if complete or almost complete response after neoadjuvant treatment for locally advanced rectal cancer Receives: Other: Organ Preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of organ preservative strategies after neoadjuvant treatment in locally advanced rectal cancer
Patients with a complete or almost complete response after a neoadjuvant treatment will be offered an organ preservation strategy
Measured: 5 years
Secondary outcomes (4)
Local relapse rate
Occurrence of local relapse in patients with an organ preservation strategy
Measured: 2 years and 5 years
Distant relapse rate
Occurrence of distant relapse in patients with an organ preservation strategy
Measured: 2 years and 5 years
Quality of Life in oncological patients
Assess QLQ-C30 in patients with an organ preservation strategy
Measured: 3 months; 1 year and annually until 5 years
Quality of Life in patient with rectal cancer
Assess QLQ-CR38 in patients with an organ preservation strategy
Measured: 3 months, 1 year and annually until 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start10 Mar 2017
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LOCALLY ADVANCED 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Elche
- Responsible party
- Principal investigator, Javier Gallego Plazas, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Investigators
- Javier Gallego, PhD, Principal investigator, Hospital General Universitario de ElcheJavier Gallego, PhD, Study director, Hospital General Universitario de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064646
- Sponsor's protocol ID
- PRONAR V1.0: 19DEC2016
- Acronym
- PRONAR
- Status last verified
- Sep 2018
- First submitted
- 16 Feb 2017
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is planned to share global data analysis
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORGAN PRESERVATION AFTER NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED RECTAL CANCER
- ClinicalTrials.gov ID
- NCT03064646
- Acronym / sponsor ID
- PRONAR / PRONAR V1.0: 19DEC2016
- Conditions
- LOCALLY ADVANCED RECTAL CANCER
- Keywords
- ORGAN PRESERVATION, WATCH AND WAIT, TRANSANAL ENDOSCOPIC MICROSURGERY
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Collaborators
- Hospital General Universitario Elche
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Feb 2017 (actual)
- 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.
PRONAR trial aims to assess if treatment with organ preservation in stage II and III rectal cancer after a complete or almost complete response to neoadjuvant treatment is feasible and safe in our environment.
The main objective of this project is to implement the organ preservation strategy in the treatment of rectal cancer in our environment within a clinical study that allows the analysis of its results in terms of survival.
The secondary objective is to assess local relapse, distant relapse and quality of life.
Detailed description
After pathology confirmed rectal cancer patients with stage II and III (MRI, CT and endoscopy) will be identified in the first visit to Medical Oncology Department. Patients will receive the most appropriate neoadjuvant treatment according to clinical guidelines.
Response to neoadjuvant treatment will be assessed by MRI. Those patients with a complete response in MRI, confirmed by endoscopy, will be offered a "watch and wait" strategy. Patients with a complete response in MRI, with an almost complete response in endoscopy, will be offered transanal endoscopic microsurgery. All patients with complete or near complete response will sign an informed consent before study entry.
Radical surgery will be performed in patients without complete or almost complete response criteria after neoadjuvant treatment.
Patients in organ preserving strategy will be subjected to a more intensive follow up schedule, including MRI and endoscopy, compared to patients with radical surgery.
As the complete histopathologic response rate after neoadjuvant treatment in locally advanced rectal cancer is approximately 15-20%, considering that approximately 40 patients with locally advanced rectal cancer are diagnosed annually in our setting, approximately 6-8 patients per year could be potentially recruited for this project, until reaching an initial sample of 30 patients for evaluation.
The following results will be analyzed:
- Percentage of complete and almost complete responses.
- Percentage of watch and wait and transanal endoscopic microsurgery.
- Disease free survival.
- Overall survival.
- Local relapse rate.
- Distant relapse rate.
- Treatment and outcomes of relapses.
- Colostomy free survival.
- Quality of life.
All data will be obtained from patient's medical records
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Organ Preservation | Experimental | Other: Organ PreservationThe experimental strategy is the omission of radical surgery if complete or almost complete response after neoadjuvant treatment for locally advanced rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with confirmed histopathological diagnosis of rectal adenocarcinoma.
- Patients treated with neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy associated or not with induction chemotherapy.
- Patients with evidence of complete or near complete response criteria after completion of neoadjuvant treatment (approximately 8 weeks later). Response criteria should be based on digital rectal examination, flexible rectoscopy and MRI.
Key exclusion criteria (1 listed)
- Evidence of distant metastases.
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 |
|---|---|---|
| Organ PreservationAlso: Transanal Endoscopic Microsurgery, Watch and WaitPatients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy | Other | Organ Preservation |
Primary outcome
Percentage of organ preservative strategies after neoadjuvant treatment in locally advanced rectal cancer
Time frame: 5 years
Patients with a complete or almost complete response after a neoadjuvant treatment will be offered an organ preservation strategy
4 secondary outcomes
Local relapse rate
Time frame: 2 years and 5 years
Distant relapse rate
Time frame: 2 years and 5 years
Quality of Life in oncological patients
Time frame: 3 months; 1 year and annually until 5 years
Quality of Life in patient with rectal cancer
Time frame: 3 months, 1 year and annually until 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: No. It is planned to share global data analysis
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Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer
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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.
Javier Gallego, PhD principal investigator
Hospital General Universitario de Elche
Javier Gallego, PhD study director
Hospital General Universitario de Elche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organ Preservation in people with LOCALLY ADVANCED RECTAL CANCER, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Sep 2018. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Gallego, PhD (+34966616250, j.gallegoplazas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of organ preservative strategies after neoadjuvant treatment in locally advanced rectal cancer (time frame: 5 years). 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 27 Sep 2018.