Rectal CancerPhase 3NCT06097416
Neoadjuvant Chemoradiotherapy Versus Total Neoadjuvant Therapy in the Treatment of T3 Rectal Cancer
A Phase 3 study testing Neoadjuvant Chemoradiotherapy and Total Neoadjuvant Therapy in people with Rectal Cancer, run by St. James's Hospital, Ireland.
Trial summary
The gold standard treatment for locally advanced, non-metastatic rectal cancer includes neoadjuvant chemoradiotherapy (NACRT), total mesorectal excision (TME) and adjuvant chemotherapy (AC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Neoadjuvant Chemoradiotherapy and Total Neoadjuvant Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2030
- Phase
- Phase 3
- 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
None listed.
Who cannot join
- Patients who meet any of the following criteria at the time of screening will be excluded from study registration:
- Received prior chemotherapy for local or metastatic disease.
- Locally advanced rectal cancer; >T3, Nodal disease
- Primary unresectable rectal cancer. A tumour is considered unresectable when invading adjacent organs and an en bloc resection will not achieve negative margins.
- Received prior pelvic radiotherapy.
- Patients unable to undergo MRI.
Show all 29Show fewer
- Previous or concurrent active malignancy ≤ 5 years prior to registration with the exception of non-melanotic skin cancer or carcinoma in situ of any type, or other cancers that the treating Investigator does not feel will impact the study objectives.
- Screening electrocardiogram (ECG) with evidence of:
- QT prolongation (QTc > 450ms in males and > 470ms in females)
- Clinically significant cardiac arrhythmias, complete left bundle branch block, high atrioventricular AV block (e.g. bi-vascular block , Mobitz type II and third degree AV block
- Other severe cardiac dysfunction
- (ECG must be assessed for all patients within 14 days prior to registration).
- Clinically significant cardiovascular disease including:
- Cerebrovascular accident within 6 months prior to registration
- Myocardial infarction within 6 months prior to registration
- Uncontrolled angina
- Uncontrolled or poorly controlled arterial hypertension (i.e. BP >150/90mmHg under treatment with at a maximum three antihypertensive drugs)
- Clinically significant valvular disease
- Congestive Heart Failure (NYHA > Class 2 (See Appendix E)
- Known family history of idiopathic cardiac arrest or sudden death whereby a cardiac cause cannot be excluded
- Known history or family history of Brugada Syndrome.
- Known pulmonary compromise, as determined by the treating investigator, resulting from intercurrent pulmonary illness, but not limited to, any pulmonary disorder (e.g. severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease.
- Creatinine level >1.5x ULN
- Patients with a history of any arterial thromobotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA or CVA.
- Patients with a history of venous thrombotic episodes such as DVT, PE occurring more than 6 months prior to enrolment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.
- Pregnant or nursing women.
- Concurrent treatment with any other investigational agents within 30 days prior to registration.
- Any psychological, physical, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; (those conditions should be discussed with the patient before registration in the trial).
- Unable or unwilling to discontinue (and substitute if necessary) use of prohibited medications for at least 30 days prior to and for the duration of study treatment (see section 7.5 for a description of prohibited medications).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase III, Multi-institutional Randomised Trial Comparing Neoadjuvant Chemoradiotherapy (NARCT) and Total Neoadjuvant Therapy (TNT) in Patients With T3 (a/b/c) Rectal Cancer
The gold standard treatment for locally advanced, non-metastatic rectal cancer includes neoadjuvant chemoradiotherapy (NACRT), total mesorectal excision (TME) and adjuvant chemotherapy (AC). The primary goal of treatment is to achieve local disease control, reduce tumour volume and minimise the risk of distant metastases. While this multimodal treatment approach has offered improvements in local control and sphincter preservation, it has had little effect on distant recurrence and overall survival. We aim to compare NACRT and TME using the following endpoints:
Primary -->To compare the effects neoadjuvant chemoradiotherapy versus total neoadjuvant therapy (TNT) for T3 rectal cancer on overall survival.
Read more
Secondary --> To compare the effects neoadjuvant chemoradiotherapy (NARCT) and total neoadjuvant therapy (TNT) for cT3 rectal cancer on clinical outcomes:
- Clinical complete response (cCR)
- Pathological complete response (pCR)
- Disease-free survival (DFS)
- Organ preservation
- Overall morbidity / mortality
- Treatment-related morbidity / mortality
- Peri-operative outcomes
- Conditions
- Rectal Cancer
- Being tested
- Neoadjuvant Chemoradiotherapy, Total Neoadjuvant Therapy
- Keywords
- Rectal cancer, Neoadjuvant chemoradiotherapy, Total neoadjuvant therapy, Survival
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant ChemoradiotherapyDrug
Also called NACRT
5-FU is a fluoropyrimidine antimetabolite considered to act primarily as an inhibitor of thymidylate synthase. 5-FU is supplied as a colourless-to-faint yellow solution in 10-mL single use vials. Each 10 mL of solution contains 500 mg 5-FU, with pH adjusted to approximately 9.2 with sodium hydroxide.
The CRT regimen consists of the standard algorithms: a total of 5400-5600 cGy of radiation (4500 cGy to the pelvis, with an integrated boost to the primary tumour and involved nodes of 500 cGy followed by an option boost to the primary tumour and involved nodes) delivered in 27-28 fractions, respectively, of 180-200 cGy each over a 5-6 week period.
Total Neoadjuvant TherapyDrug
Also called TNT
5-FU is a fluoropyrimidine antimetabolite considered to act primarily as an inhibitor of thymidylate synthase. 5-FU is supplied as a colourless-to-faint yellow solution in 10-mL single use vials. Each 10 mL of solution contains 500 mg 5-FU, with pH adjusted to approximately 9.2 with sodium hydroxide.
Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2- diaminocyclohexane with an oxalate ligand as a leaving group. Platinum content is 48.1% to 50.1%.
All patients received the same chemotherapy (FOLFOX) and long-course chemoradiotherapy (50.4 Gy in 28 fractions) before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemoradiotherapy | Active comparator | The NARCT regimen is prescribed specifically as standard 5-FU over several weeks. The CRT regimen consists of the standard algorithms: a total of 5400-5600 cGy of radiation (4500 cGy to the pelvis, with an integrated boost to the primary tumour and involved nodes of 500 cGy followed by an option boost to the primary tumour and involved nodes) delivered in 27-28 fractions, respectively, of 180-200 cGy each over a 5-6 week period. Receives: Drug: Neoadjuvant Chemoradiotherapy |
| Total Neoadjuvant Therapy | Active comparator | Sequence of TNT regimen can be classified as induction (chemotherapy first) or consolidation (radiation first) treatment. All patients received the same chemotherapy (FOLFOX) and long-course chemoradiotherapy (50.4 Gy in 28 fractions) before surgery. However timing of TNT can differ depending on concerns of local and distal failure. Receives: Drug: Total Neoadjuvant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Alive
Measured: Five years
Secondary outcomes (4)
Clinical complete response
No residual tumour visible on imaging
Measured: 6 months
Pathological complete response
Absence of residual invasive or in situ tumour on biopsy / resected specimen.
Measured: 6 months
Disease-free survival
Measure of time after treatment where no evidence of disease is found.
Measured: 5 years
Progression-free survival
Time from randomisation to occurrence of disease progression or death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Kelly, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097416
- Sponsor's protocol ID
- St. James's Hospital
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.
PubMed 15496622Kong JC, Soucisse M, Michael M, Tie J, Ngan SY, Leong T, McCormick J, Warrier SK, Heriot AG. Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Systematic Review and Metaanalysis of Oncological and Operative Outcomes. Ann Surg Oncol. 2021 Nov;28(12):7476-7486. doi: 10.1245/s10434-021-09837-8. Epub 2021 Apr 23.
PubMed 33891203Feeney G, Sehgal R, Sheehan M, Hogan A, Regan M, Joyce M, Kerin M. Neoadjuvant radiotherapy for rectal cancer management. World J Gastroenterol. 2019 Sep 7;25(33):4850-4869. doi: 10.3748/wjg.v25.i33.4850.
PubMed 31543678Hoendervangers S, Burbach JPM, Lacle MM, Koopman M, van Grevenstein WMU, Intven MPW, Verkooijen HM. Pathological Complete Response Following Different Neoadjuvant Treatment Strategies for Locally Advanced Rectal Cancer: A Systematic Review and Meta-analysis. Ann Surg Oncol. 2020 Oct;27(11):4319-4336. doi: 10.1245/s10434-020-08615-2. Epub 2020 Jun 10.
PubMed 32524461Lorimer PD, Motz BM, Kirks RC, Boselli DM, Walsh KK, Prabhu RS, Hill JS, Salo JC. Pathologic Complete Response Rates After Neoadjuvant Treatment in Rectal Cancer: An Analysis of the National Cancer Database. Ann Surg Oncol. 2017 Aug;24(8):2095-2103. doi: 10.1245/s10434-017-5873-8. Epub 2017 May 22.
PubMed 28534080Li Y, Wang J, Ma X, Tan L, Yan Y, Xue C, Hui B, Liu R, Ma H, Ren J. A Review of Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer. Int J Biol Sci. 2016 Jul 17;12(8):1022-31. doi: 10.7150/ijbs.15438. eCollection 2016.
PubMed 27489505Bujko K, Wyrwicz L, Rutkowski A, Malinowska M, Pietrzak L, Krynski J, Michalski W, Oledzki J, Kusnierz J, Zajac L, Bednarczyk M, Szczepkowski M, Tarnowski W, Kosakowska E, Zwolinski J, Winiarek M, Wisniowska K, Partycki M, Beczkowska K, Polkowski W, Stylinski R, Wierzbicki R, Bury P, Jankiewicz M, Paprota K, Lewicka M, Cisel B, Skorzewska M, Mielko J, Bebenek M, Maciejczyk A, Kapturkiewicz B, Dybko A, Hajac L, Wojnar A, Lesniak T, Zygulska J, Jantner D, Chudyba E, Zegarski W, Las-Jankowska M, Jankowski M, Kolodziejski L, Radkowski A, Zelazowska-Omiotek U, Czeremszynska B, Kepka L, Kolb-Sielecki J, Toczko Z, Fedorowicz Z, Dziki A, Danek A, Nawrocki G, Sopylo R, Markiewicz W, Kedzierawski P, Wydmanski J; Polish Colorectal Study Group. Long-course oxaliplatin-based preoperative chemoradiation versus 5 x 5 Gy and consolidation chemotherapy for cT4 or fixed cT3 rectal cancer: results of a randomized phase III study. Ann Oncol. 2016 May;27(5):834-42. doi: 10.1093/annonc/mdw062. Epub 2016 Feb 15.
PubMed 26884592
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-institutional Randomised Trial Comparing Neoadjuvant Chemoradiotherapy (NARCT) and Total Neoadjuvant Therapy (TNT) in Patients With T3 (a/b/c) Rectal Cancer
- ClinicalTrials.gov ID
- NCT06097416
- Acronym / sponsor ID
- St. James's Hospital
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Neoadjuvant chemoradiotherapy, Total neoadjuvant therapy, Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 24 Oct 2023 (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.
The gold standard treatment for locally advanced, non-metastatic rectal cancer includes neoadjuvant chemoradiotherapy (NACRT), total mesorectal excision (TME) and adjuvant chemotherapy (AC). The primary goal of treatment is to achieve local disease control, reduce tumour volume and minimise the risk of distant metastases. While this multimodal treatment approach has offered improvements in local control and sphincter preservation, it has had little effect on distant recurrence and overall survival. We aim to compare NACRT and TME using the following endpoints:
Primary -->To compare the effects neoadjuvant chemoradiotherapy versus total neoadjuvant therapy (TNT) for T3 rectal cancer on overall survival.
Secondary --> To compare the effects neoadjuvant chemoradiotherapy (NARCT) and total neoadjuvant therapy (TNT) for cT3 rectal cancer on clinical outcomes:
- Clinical complete response (cCR)
- Pathological complete response (pCR)
- Disease-free survival (DFS)
- Organ preservation
- Overall morbidity / mortality
- Treatment-related morbidity / mortality
- Peri-operative outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemoradiotherapy | Active comparator | Drug: Neoadjuvant ChemoradiotherapyThe NARCT regimen is prescribed specifically as standard 5-FU over several weeks. The CRT regimen consists of the standard algorithms: a total of 5400-5600 cGy of radiation (4500 cGy to the pelvis, with an integrated boost to the primary tumour and involved nodes of 500 cGy followed by an option boost to the primary tumour and involved nodes) delivered in 27-28 fractions, respectively, of 180-200 cGy each over a 5-6 week period. |
| Total Neoadjuvant Therapy | Active comparator | Drug: Total Neoadjuvant TherapySequence of TNT regimen can be classified as induction (chemotherapy first) or consolidation (radiation first) treatment. All patients received the same chemotherapy (FOLFOX) and long-course chemoradiotherapy (50.4 Gy in 28 fractions) before surgery. However timing of TNT can differ depending on concerns of local and distal failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (29 listed)
- Patients who meet any of the following criteria at the time of screening will be excluded from study registration:
- Received prior chemotherapy for local or metastatic disease.
- Locally advanced rectal cancer; >T3, Nodal disease
- Primary unresectable rectal cancer. A tumour is considered unresectable when invading adjacent organs and an en bloc resection will not achieve negative margins.
- Received prior pelvic radiotherapy.
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 ChemoradiotherapyAlso: NACRT5-FU is a fluoropyrimidine antimetabolite considered to act primarily as an inhibitor of thymidylate synthase. 5-FU is supplied as a colourless-to-faint yellow solution in 10-mL single use vials. Each 10 mL of solution contains 500 mg 5-FU, with pH adjusted to approximately 9.2 with sodium hydroxide. The CRT regimen consists of the standard algorithms: a total of 5400-5600 cGy of radiation (4500 cGy to the pelvis, with an integrated boost to the primary tumour and involved nodes of 500 cGy followed by an option boost to the primary tumour and involved nodes) delivered in 27-28 fractions, respectively, of 180-200 cGy each over a 5-6 week period. | Drug | Neoadjuvant chemoradiotherapy |
| Total Neoadjuvant TherapyAlso: TNT5-FU is a fluoropyrimidine antimetabolite considered to act primarily as an inhibitor of thymidylate synthase. 5-FU is supplied as a colourless-to-faint yellow solution in 10-mL single use vials. Each 10 mL of solution contains 500 mg 5-FU, with pH adjusted to approximately 9.2 with sodium hydroxide. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2- diaminocyclohexane with an oxalate ligand as a leaving group. Platinum content is 48.1% to 50.1%. All patients received the same chemotherapy (FOLFOX) and long-course chemoradiotherapy (50.4 Gy in 28 fractions) before surgery. | Drug | Total Neoadjuvant Therapy |
Primary outcome
Overall survival
Time frame: Five years
Alive
4 secondary outcomes
Clinical complete response
Time frame: 6 months
Pathological complete response
Time frame: 6 months
Disease-free survival
Time frame: 5 years
Progression-free survival
Time frame: 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 25 Oct 2023.
- Background: PubMed 15496622Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.
- Background: PubMed 33891203Kong JC, Soucisse M, Michael M, Tie J, Ngan SY, Leong T, McCormick J, Warrier SK, Heriot AG. Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Systematic Review and Metaanalysis of Oncological and Operative Outcomes. Ann Surg Oncol. 2021 Nov;28(12):7476-7486. doi: 10.1245/s10434-021-09837-8. Epub 2021 Apr 23.
- Background: PubMed 31543678Feeney G, Sehgal R, Sheehan M, Hogan A, Regan M, Joyce M, Kerin M. Neoadjuvant radiotherapy for rectal cancer management. World J Gastroenterol. 2019 Sep 7;25(33):4850-4869. doi: 10.3748/wjg.v25.i33.4850.
- Background: PubMed 32524461Hoendervangers S, Burbach JPM, Lacle MM, Koopman M, van Grevenstein WMU, Intven MPW, Verkooijen HM. Pathological Complete Response Following Different Neoadjuvant Treatment Strategies for Locally Advanced Rectal Cancer: A Systematic Review and Meta-analysis. Ann Surg Oncol. 2020 Oct;27(11):4319-4336. doi: 10.1245/s10434-020-08615-2. Epub 2020 Jun 10.
- Background: PubMed 28534080Lorimer PD, Motz BM, Kirks RC, Boselli DM, Walsh KK, Prabhu RS, Hill JS, Salo JC. Pathologic Complete Response Rates After Neoadjuvant Treatment in Rectal Cancer: An Analysis of the National Cancer Database. Ann Surg Oncol. 2017 Aug;24(8):2095-2103. doi: 10.1245/s10434-017-5873-8. Epub 2017 May 22.
- Background: PubMed 27489505Li Y, Wang J, Ma X, Tan L, Yan Y, Xue C, Hui B, Liu R, Ma H, Ren J. A Review of Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer. Int J Biol Sci. 2016 Jul 17;12(8):1022-31. doi: 10.7150/ijbs.15438. eCollection 2016.
- Background: PubMed 26884592Bujko K, Wyrwicz L, Rutkowski A, Malinowska M, Pietrzak L, Krynski J, Michalski W, Oledzki J, Kusnierz J, Zajac L, Bednarczyk M, Szczepkowski M, Tarnowski W, Kosakowska E, Zwolinski J, Winiarek M, Wisniowska K, Partycki M, Beczkowska K, Polkowski W, Stylinski R, Wierzbicki R, Bury P, Jankiewicz M, Paprota K, Lewicka M, Cisel B, Skorzewska M, Mielko J, Bebenek M, Maciejczyk A, Kapturkiewicz B, Dybko A, Hajac L, Wojnar A, Lesniak T, Zygulska J, Jantner D, Chudyba E, Zegarski W, Las-Jankowska M, Jankowski M, Kolodziejski L, Radkowski A, Zelazowska-Omiotek U, Czeremszynska B, Kepka L, Kolb-Sielecki J, Toczko Z, Fedorowicz Z, Dziki A, Danek A, Nawrocki G, Sopylo R, Markiewicz W, Kedzierawski P, Wydmanski J; Polish Colorectal Study Group. Long-course oxaliplatin-based preoperative chemoradiation versus 5 x 5 Gy and consolidation chemotherapy for cT4 or fixed cT3 rectal cancer: results of a randomized phase III study. Ann Oncol. 2016 May;27(5):834-42. doi: 10.1093/annonc/mdw062. Epub 2016 Feb 15.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neoadjuvant Chemoradiotherapy and Total Neoadjuvant Therapy in people with Rectal Cancer, run by St. James's Hospital, Ireland.
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 0 inclusion and 29 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: opening soon, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Michael Kelly, PhD (00353876638956, kellym11@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06097416, which also lists 7 linked publications.
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 25 Oct 2023.