ClinicalTrials.gg
Not yet recruitingNCT07927764PFLUpdated Nov 10, 2026

Predictive Factors of Long-term Survivor (LTS) of Patients With Recurrent or Metastatic, Radio-iodine Resistant Differentiated Thyroid Cancer (RRDTC) After Lenvatinib: a Multicenter Study

An observational study in Head and Neck Cancer, sponsored by IRCCS San Raffaele. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by IRCCS San Raffaele · Observational

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
65
Ages
18 Years and older
Sex
All
01

Study summary

This is an observational, pharmacological, retrospective, multicenter study and involves a total of 4 enrolling centers. This study aims to demonstrate that, in real-world clinical practice, the survival of RAI-refractory patients treated with Lenvatinib is significantly greater than the 30 months described by Gianoukakis et al., reaching-and in some cases exceeding-5 years.

02

Conditions studied

  • Head and Neck Cancer
03

In context

Head and Neck Neoplasms

2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.

This study's planned enrollment of 65 is below the median of 100 across 502 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with recurrent or metastatic, radio-iodine resistant differentiated thyroid cancer (RRDTC) treated with Lenvatinib

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients (≥ 18 years of age)
  • Patients capable of providing
  • Patients with a diagnosis of differentiated thyroid carcinoma confirmed by cytological or histological examination, showing disease progression within the last 12 months
  • Patients with radioiodine- differentiated thyroid carcinoma (i.e., patients with one or more lesions without RAI uptake; patients with progressive lesions lacking RAI uptake within the last 12 months; or patients who have received a cumulative RAI dose > 600 mCi)
  • performance status of 0-2
  • Patients who are treatment-naïve or with disease recurrence following therapy
  • Patients with blood pressure ≤ 150/90 mmHg and adequate bone marrow, liver, and renal function ( > 30 mL/min calculated using the Cockcroft-Gault formula)

Exclusion criteria

Exclusion Criteria:

  • Patients with medullary or anaplastic thyroid carcinoma
  • Patients with impaired renal function or proteinuria (urinary protein >1 g/24 h)
  • Patients with a positive medical history of congestive heart failure, unstable angina, ischemic heart disease, ischemic stroke, or cardiac arrhythmias in the last 6 months
  • Patients with a prolonged on pre-treatment
  • Patients previously treated with Lenvatinib
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
65 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Median Duration of Overall Response (DOR) in a Real-World Setting

    Assessment of the median duration of overall response (DOR) in a real-world setting in patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid cancer who achieved stable disease (SD), complete response (CR), or partial response (PR) following treatment with lenvatinib.

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Dec 2026, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2026
First posted
Nov 10, 2026
StartEst.
Dec 2026
Primary completionEst.
Dec 2026
CompletionEst.
Jun 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07927764
Lead sponsor
IRCCS San Raffaele
Responsible party
Aurora Mirabile (Medical Oncologist, IRCCS San Raffaele) — Principal investigator
First posted
Nov 10, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Aurora AM Mirabile, MD
Contact
mirabile.aurora@hsr.it
0226433526

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion