Head and Neck CancerPhase 2NCT07856719
A Ph2, Colchicine For Inflammatory Carotid Injury And Disease Evolution After Radiotherapy
A Phase 2 study testing Colchicine in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find out if low-dose colchicine (an anti-inflammatory drug) lowers the rate of radiation-related side effects to the carotid artery in patients who have completed radiation therapy for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 1 Jul 2034
- Phase
- Phase 2
- 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
- Adults aged ≥18 years.
- Clinical diagnosis of head and neck cancer (HNC), including malignancies of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or salivary glands.
- Receipt of curative-intent radiotherapy to the neck, completed ≤18 months prior to randomization.
- No evidence of locoregional or distant disease recurrence, confirmed by standard-of-care imaging at 3-6 months post-RT completion as documented by the treating head and neck radiation oncologist. Participants must not be scheduled to receive additional cancerdirected systemic or radiation therapy during the study period.
- ECOG performance status ≤2.
- For women of childbearing potential (WOCBP): negative serum or urine pregnancy test within 7 days prior to randomization and agreement to use adequate contraception for the duration of study treatment and for at least 30 days following the last dose of study drug. WOCBP is defined as any female between the onset of menses and 55 years of age unless an applicable exclusionary factor is present (postmenopausal ≥12 consecutive months without menses; history of hysterectomy or bilateral salpingo-oophorectomy; history of bilateral tubal ligation or other surgical sterilization). Approved methods of contraception include hormonal contraception (oral, injectable, implantable, transdermal, or vaginal ring), intrauterine device (IUD), and barrier methods (condom plus spermicide). Periodic abstinence and the rhythm method are not acceptable. (Refer to MD Anderson Institutional Policy #CLN1114.) Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Male participants must agree to use adequate contraception for the duration of study treatment, given the potential effects of colchicine on spermatogenesis through microtubule inhibition.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Palliative or non-curative intent radiotherapy.
- Known carotid artery stenosis ≥50% at baseline screening.
- Prior history of radiotherapy to the neck (other than the qualifying course of RT for this study), carotid artery dissection, or prior carotid revascularization (endarterectomy or stenting).
- Known hypersensitivity or prior intolerance to colchicine.
- Current chronic use of colchicine for any other indication.
- Severe renal impairment (eGFR <30 mL/min/1.73 m² by CKD-EPI equation) or end-stage renal disease requiring dialysis.
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- Severe hepatic impairment (Child-Turcotte-Pugh class C).
- Pre-existing significant blood dyscrasia, defined as absolute neutrophil count <1,500 cells/mm³ or platelet count <50,000 cells/mm³.
- Concurrent requirement for strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, cyclosporine) or P-glycoprotein (P-gp) inhibitors that cannot be discontinued for the duration of study treatment. A list of prohibited concomitant medications is provided in Appendix A.
- History of peripheral neuritis, myositis, or clinically significant myopathy attributed to statin therapy.
- Chronic systemic corticosteroid use for any ongoing medical condition.
- Pregnancy, breastfeeding, or expressed intent to become pregnant during the study period.
- Concurrent enrollment in another clinical trial with an active interventional treatment arm.
- Psychiatric illness or social circumstances that would limit compliance with study requirements or follow-up.
- Any condition that, in the opinion of the investigator, would prevent protocol adherence or compromise participant safety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson
Houston, Texas, 77030
Efstratios Koutroumpakis, MD, 713-563-5439, ekoutroumpakis@mdanderson.org
Efstratios Koutroumpakis, MD
About this study
Official title: COINCIDE-RT: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single-Center Trial Of Low-Dose Colchicine For The Prevention Of Radiation-Induced Carotid Artery Disease In Survivors Of Head And Neck Cancer (Colchicine For Inflammatory Carotid Injury And Disease Evolution After Radiotherapy [COINCIDE-RT])
The goal of this clinical research study is to find out if low-dose colchicine (an anti-inflammatory drug) lowers the rate of radiation-related side effects to the carotid artery in patients who have completed radiation therapy for head and neck cancer.
Read the detailed description
Primary Objective:
To evaluate whether low-dose colchicine (0.6 mg orally once daily for 24 months) reduces radiation-induced carotid vascular injury compared to placebo in survivors of head and neck cancer who have completed curative-intent radiotherapy, as assessed by a hierarchical composite endpoint analyzed using the win ratio method, comprising: (1) time to death; (2) time to TIA, CVA, or ischemic heart disease; (3) time to carotid artery stenosis >50%; and (4) change in carotid intima-media thickness (CIMT) from pre-radiotherapy baseline to 24 months postrandomization.
Secondary Objective:
Efficacy
- To evaluate the effect of colchicine on each individual component of the primary hierarchical composite endpoint.
- To assess carotid plaque development, progression, and regression by serial duplex ultrasound.
- To characterize longitudinal CIMT trajectory from pre-radiotherapy baseline through the 24-month intervention period using all available imaging timepoints.
- To evaluate carotid artery volume change from pre-radiotherapy baseline to month 24. Safety and tolerability
- To evaluate the safety and tolerability of low-dose colchicine in HNC survivors, with adverse events graded per CTCAE v6.0.
- To assess study medication adherence.
- To assess the rate of locoregional and distant cancer recurrence during the study period. Exploratory and correlative
- To determine whether baseline SASP-related circulating biomarkers (GAGome, serum glutamate, H₂S) and CHIP status predict RICAD risk and treatment response to colchicine.
- To evaluate ALDH2 expression and 4-HNE adduct levels in PBMCs as pharmacodynamic markers of colchicine target engagement.
- To assess whether the baseline NAA index refines RICAD risk stratification beyond traditional cardiovascular risk factors.
- To develop a clinical decision support tool integrating baseline clinical characteristics, 3D dosimetry, and carotid imaging to predict adverse carotid outcomes following RT.
- Conditions
- Head and Neck Cancer
- Being tested
- Colchicine, Placebo
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Colcrys, Mitigare, Gloperba, Lodoco
0.6 mg given by mouth once daily for 24 months
PlaceboOther
Given by mouth once daily for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Double- blind Treatment with Colchicine or Placebo | Experimental | Treatment will be administeredon an outpatient basis Receives: Drug: Colchicine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Jul 2032 (estimated)
- Study completion1 Jul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Efstratios Koutroumpakis, MD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856719
- Sponsor's protocol ID
- 2026-0662
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COINCIDE-RT: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single-Center Trial Of Low-Dose Colchicine For The Prevention Of Radiation-Induced Carotid Artery Disease In Survivors Of Head And Neck Cancer (Colchicine For Inflammatory Carotid Injury And Disease Evolution After Radiotherapy [COINCIDE-RT])
- ClinicalTrials.gov ID
- NCT07856719
- Acronym / sponsor ID
- 2026-0662
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Jul 2032 (estimated)
- Study completion
- 1 Jul 2034 (estimated)
- First posted
- 5 Oct 2026 (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 goal of this clinical research study is to find out if low-dose colchicine (an anti-inflammatory drug) lowers the rate of radiation-related side effects to the carotid artery in patients who have completed radiation therapy for head and neck cancer.
Detailed description
Primary Objective:
To evaluate whether low-dose colchicine (0.6 mg orally once daily for 24 months) reduces radiation-induced carotid vascular injury compared to placebo in survivors of head and neck cancer who have completed curative-intent radiotherapy, as assessed by a hierarchical composite endpoint analyzed using the win ratio method, comprising: (1) time to death; (2) time to TIA, CVA, or ischemic heart disease; (3) time to carotid artery stenosis >50%; and (4) change in carotid intima-media thickness (CIMT) from pre-radiotherapy baseline to 24 months postrandomization.
Secondary Objective:
Efficacy
- To evaluate the effect of colchicine on each individual component of the primary hierarchical composite endpoint.
- To assess carotid plaque development, progression, and regression by serial duplex ultrasound.
- To characterize longitudinal CIMT trajectory from pre-radiotherapy baseline through the 24-month intervention period using all available imaging timepoints.
- To evaluate carotid artery volume change from pre-radiotherapy baseline to month 24. Safety and tolerability
- To evaluate the safety and tolerability of low-dose colchicine in HNC survivors, with adverse events graded per CTCAE v6.0.
- To assess study medication adherence.
- To assess the rate of locoregional and distant cancer recurrence during the study period. Exploratory and correlative
- To determine whether baseline SASP-related circulating biomarkers (GAGome, serum glutamate, H₂S) and CHIP status predict RICAD risk and treatment response to colchicine.
- To evaluate ALDH2 expression and 4-HNE adduct levels in PBMCs as pharmacodynamic markers of colchicine target engagement.
- To assess whether the baseline NAA index refines RICAD risk stratification beyond traditional cardiovascular risk factors.
- To develop a clinical decision support tool integrating baseline clinical characteristics, 3D dosimetry, and carotid imaging to predict adverse carotid outcomes following RT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double- blind Treatment with Colchicine or Placebo | Experimental | Drug: Colchicine, Other: PlaceboTreatment will be administeredon an outpatient basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged ≥18 years.
- Clinical diagnosis of head and neck cancer (HNC), including malignancies of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or salivary glands.
- Receipt of curative-intent radiotherapy to the neck, completed ≤18 months prior to randomization.
- No evidence of locoregional or distant disease recurrence, confirmed by standard-of-care imaging at 3-6 months post-RT completion as documented by the treating head and neck radiation oncologist. Participants must not be scheduled to receive additional cancerdirected systemic or radiation therapy during the study period.
- ECOG performance status ≤2.
Key exclusion criteria (15 listed)
- Palliative or non-curative intent radiotherapy.
- Known carotid artery stenosis ≥50% at baseline screening.
- Prior history of radiotherapy to the neck (other than the qualifying course of RT for this study), carotid artery dissection, or prior carotid revascularization (endarterectomy or stenting).
- Known hypersensitivity or prior intolerance to colchicine.
- Current chronic use of colchicine for any other indication.
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 |
|---|---|---|
| ColchicineAlso: Colcrys, Mitigare, Gloperba, Lodoco0.6 mg given by mouth once daily for 24 months | Drug | Double- blind Treatment with Colchicine or Placebo |
| PlaceboGiven by mouth once daily for 24 months | Other | Double- blind Treatment with Colchicine or Placebo |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
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 5 Oct 2026.
- UT MD Anderson WebsiteLink provided by the sponsor.
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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.
Efstratios Koutroumpakis, MD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 8 inclusion and 15 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 5 Oct 2026. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Efstratios Koutroumpakis, MD ((713) 563-5439, ekoutroumpakis@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 5 Oct 2026.