Locally Advanced Rectal CancerLiBReCaNCT03699410
Observational Study on Rectal Cancer to Verify if Response After Chemo-radiotherapy Can be Predicted With a Particular Blood Test.
An observational study of Locally Advanced Rectal Cancer, run by Dimitri Christoforidis at 2 sites in Switzerland.
Trial summary
Research project for patients with locally advanced rectal cancer in which biological material and health-related personal data are collected. The aim is to investigate if an additional method (liquid biopsies) can predict the response after chemo-radiotherapy and before surgery. 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?
- Neoadjuvant radiotherapy, Neoadjuvant chemotherapy and Radical surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 25 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 28 Aug 2018to 20 Oct 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced rectal cancer afferent to participating sites
Who may be able to join
- Age ≥ 18 years old
- Locally advanced rectal cancer (T3 or T4, and/or N+) requiring long course nCRT (as decided by the regional tumor board)
- Patient fit for surgery and treated with curative intent
- Willingness to complete all clinical and radiological examinations foreseen by the study
- Availability of tissue specimen for molecular characterization at baseline
- Written informed consent
Who cannot join
- Presence of metastases
- Insufficient material on the tissue biopsy to be left in archives of the Cantonal Institute of Pathology for further evaluations/analyses
- Insufficient amount of tumor cells in the tissue biopsy for the molecular characterization
- Inability to consent and follow the procedures of the study
- Women who are pregnant or breast feeding
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Regional Hospital of Lugano
Lugano, 6900
Clinica Luganese Moncucco
Lugano, 6903
About this study
Official title: A Proof-of-concept, Prospective, Observational Study to Investigate the Value of Liquid Biopsies to Predict Tumor Response After Neoadjuvant Chemo-radiotherapy in Patients With Locally Advanced Rectal Cancer: the LiBReCa Study
Research project for patients with locally advanced rectal cancer in which biological material and health-related personal data are collected.
The aim is to investigate if an additional method (liquid biopsies) can predict the response after chemo-radiotherapy and before surgery.
Read the detailed description
The standard treatment for locally advanced rectal cancer (T3 -T4 and / or N+) is neoadjuvant (pre-operative) chemo-radiotherapy (nCRT) followed by radical surgery. In patients after complete response following nCRT, surgery may not add any survival benefit but it is still performed.
Since clinical complete response has only partial concordance with pathological complete response, an additional method that helps identify those patients with a true complete response is needed to avoid unnecessary surgery and its associated potential complications..
The hypothesis underlying this study is that the quantitative and qualitative evaluation of circulating tumor DNA (ctDNA) of liquid biopsy, based on the amount of ctDNA or on the detection of specific gene alterations respectively, may be directly correlated to the clinical, histopathological and radiological response of the tumor to nCRT.
This study will not interfere with the patient's routine treatment pathway and there will be no deviation from the standard of care. The only additional study intervention will be the collection of blood samples at 6 different time points which can be combined with the regular blood examination performed during the treatment.
At the time of diagnosis, tumor staging and histopathology on tumor biopsy will be performed. Patients will receive standardized neoadjuvant therapy and will be operated after an observational period of 10 weeks. Peripheral blood sample will be collected at 6 time points: pre-nCRT, at the end of the nCRT, at 4th and 7th week post-CRT, on the day of the surgery (before surgical resection), on the post-operative day 5 (in hospital). Mesenteric blood sample will be collected intra-operatively on the day of the surgery. Tumor sampling will be performed during tumor staging, as standard of care, and on the resection specimen. A combined qualitative and quantitative approach for the molecular characterization of tissue and liquid biopsy using next-generation sequencing will be carried out.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Neoadjuvant radiotherapy, Neoadjuvant chemotherapy, Radical surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant radiotherapyRadiation
Radiotherapy with total dose of at least 50 Gy on the tumor (cT) and the involved nodes (cN+) and with standard fractionation (1.8 Gy/fraction), 5 days/week.
Neoadjuvant chemotherapyDrug
Oral Capecitabine, at the standard dose of 825 mg/m2 twice daily, concomitant to radiotherapy.
Radical surgeryProcedure or surgery
The time point of surgery is usually dependent on surgeon's and institutional habits and lies within 6 to 12 weeks after the end of nCRT. Surgeons participating in this study will be asked to operate patients on the 10th week after the end of nCRT.
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Prognostic Value (NPV)
NPV of the liquid biopsy of ctDNA drawn from the mesenteric and peripheral blood
Measured: day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start28 Aug 2018
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Why it stopped: failure to identify complete responders since ctDNA disappears after radiotherapy in most patients.
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dimitri Christoforidis
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor-investigator, Dimitri Christoforidis, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Dimitri Christoforidis, Principal investigator, Surgery and Visceral Surgery Departments Regional Hospital of Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699410
- Sponsor's protocol ID
- ORL-CHIR-002
- Acronym
- LiBReCa
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2018
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept, Prospective, Observational Study to Investigate the Value of Liquid Biopsies to Predict Tumor Response After Neoadjuvant Chemo-radiotherapy in Patients With Locally Advanced Rectal Cancer: the LiBReCa Study
- ClinicalTrials.gov ID
- NCT03699410
- Acronym / sponsor ID
- LiBReCa / ORL-CHIR-002
- Conditions
- Locally Advanced Rectal Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: failure to identify complete responders since ctDNA disappears after radiotherapy in most patients.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dimitri ChristoforidisUniversity, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 9 Oct 2018 (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.
Research project for patients with locally advanced rectal cancer in which biological material and health-related personal data are collected.
The aim is to investigate if an additional method (liquid biopsies) can predict the response after chemo-radiotherapy and before surgery.
Detailed description
The standard treatment for locally advanced rectal cancer (T3 -T4 and / or N+) is neoadjuvant (pre-operative) chemo-radiotherapy (nCRT) followed by radical surgery. In patients after complete response following nCRT, surgery may not add any survival benefit but it is still performed.
Since clinical complete response has only partial concordance with pathological complete response, an additional method that helps identify those patients with a true complete response is needed to avoid unnecessary surgery and its associated potential complications..
The hypothesis underlying this study is that the quantitative and qualitative evaluation of circulating tumor DNA (ctDNA) of liquid biopsy, based on the amount of ctDNA or on the detection of specific gene alterations respectively, may be directly correlated to the clinical, histopathological and radiological response of the tumor to nCRT.
This study will not interfere with the patient's routine treatment pathway and there will be no deviation from the standard of care. The only additional study intervention will be the collection of blood samples at 6 different time points which can be combined with the regular blood examination performed during the treatment.
At the time of diagnosis, tumor staging and histopathology on tumor biopsy will be performed. Patients will receive standardized neoadjuvant therapy and will be operated after an observational period of 10 weeks. Peripheral blood sample will be collected at 6 time points: pre-nCRT, at the end of the nCRT, at 4th and 7th week post-CRT, on the day of the surgery (before surgical resection), on the post-operative day 5 (in hospital). Mesenteric blood sample will be collected intra-operatively on the day of the surgery. Tumor sampling will be performed during tumor staging, as standard of care, and on the resection specimen. A combined qualitative and quantitative approach for the molecular characterization of tissue and liquid biopsy using next-generation sequencing will be carried out.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced rectal cancer afferent to participating sites
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- Locally advanced rectal cancer (T3 or T4, and/or N+) requiring long course nCRT (as decided by the regional tumor board)
- Patient fit for surgery and treated with curative intent
- Willingness to complete all clinical and radiological examinations foreseen by the study
- Availability of tissue specimen for molecular characterization at baseline
Key exclusion criteria (5 listed)
- Presence of metastases
- Insufficient material on the tissue biopsy to be left in archives of the Cantonal Institute of Pathology for further evaluations/analyses
- Insufficient amount of tumor cells in the tissue biopsy for the molecular characterization
- Inability to consent and follow the procedures of the study
- Women who are pregnant or breast feeding
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 |
|---|---|---|
| Neoadjuvant radiotherapyRadiotherapy with total dose of at least 50 Gy on the tumor (cT) and the involved nodes (cN+) and with standard fractionation (1.8 Gy/fraction), 5 days/week. | Radiation | – |
| Neoadjuvant chemotherapyOral Capecitabine, at the standard dose of 825 mg/m2 twice daily, concomitant to radiotherapy. | Drug | – |
| Radical surgeryThe time point of surgery is usually dependent on surgeon's and institutional habits and lies within 6 to 12 weeks after the end of nCRT. Surgeons participating in this study will be asked to operate patients on the 10th week after the end of nCRT. | Procedure or surgery | – |
Primary outcome
Negative Prognostic Value (NPV)
Time frame: day of surgery
NPV of the liquid biopsy of ctDNA drawn from the mesenteric and peripheral blood
Results and safety
The study was stopped early (reason given: failure to identify complete responders since ctDNA disappears after radiotherapy in most patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
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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.
Dimitri Christoforidis principal investigator
Surgery and Visceral Surgery Departments Regional Hospital of Lugano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Rectal Cancer, run by Dimitri Christoforidis at 2 sites in Switzerland.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
The study was stopped early (reason given: failure to identify complete responders since ctDNA disappears after radiotherapy in most patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative Prognostic Value (NPV) (time frame: day of surgery). 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 13 Oct 2021.