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Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

NCT01837745 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 776

Last updated 2023-05-17

No results posted yet for this study

Summary

Open-label randomized phase III trial, using a non-inferiority comparison design. After randomization,patients will receive either post-operative radioiodine ablation with an activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation group) or be followed-up (without postoperative radioiodine ablation) (follow-up group).

The objective is to assess the non-inferiority of the proportion of patients without tumor-related event evaluated at three years after randomisation in the absence of radioiodine ablation (follow-up group) compared to the ablation group, in patients with low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx)

Conditions

  • Low Risk Differentiated Thyroid Cancer

Interventions

DRUG

rhTSH stimulation

Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment

DRUG

I131

An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.

OTHER

Follow up

* 10 (+/- 2 months) after randomization: a neck ultrasound and a serum Tg measurement after rhTSH or LT4 stimulation * 2 years (+/- 2 months) after randomization: a serum Tg measurement under LT4 treatment (Tg/LT4) * 3 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 4 years (+/- 2 months) after randomization: a serum Tg/LT4 * 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-13
Primary Completion
2022-04-01
Completion
2030-01-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01837745 on ClinicalTrials.gov