ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01837745
Previous Study | Return to List | Next Study

Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients? (ESTIMABL2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01837745
Recruitment Status : Recruiting
First Posted : April 23, 2013
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief 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)


Condition or disease Intervention/treatment Phase
Low Risk Differentiated Thyroid Cancer Drug: rhTSH stimulation Drug: I131 Other: Follow up Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Study Start Date : April 2013
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ablation group
  • Administration of 1.1 GBq of I131 is given after the second intramuscular injections of rhTSH (0.9 mg). A whole body scan (WBS) is performed 2 to 5 days after the administration or I131 with determination of the neck uptake.
  • Follow-up consists in:

    • 10 (+/- 2 months) after randomization: neck ultrasound + a serum Tg measurement after rhTSH stimulation
    • 2 years (+/- 2 months) after randomization: serum Tg measurement under LT4 treatment (Tg/LT4)
    • 3 years (+/- 2 months) after randomization: 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
Drug: rhTSH stimulation
Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment
Other Name: Thyrogen

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

Experimental: Follow up group
Patients randomized in the follow up group neither received 131I nor rhTSH. Patients will undergo the same followup procedures as patients randomized to the ablation group, except that at 10 months after randomization, Tg will be measured under LT4 treatment and not after rhTSH stimulation.
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




Primary Outcome Measures :
  1. Rate of patient without event at 3 years following randomization [ Time Frame: assessed up to 3 years ]

Secondary Outcome Measures :
  1. Lachrymal and Salivary Glands Toxicities [ Time Frame: Assessed up at inclusion, 3 months after inclusion, 1 and 3 year post-operatively ]
  2. Patient's quality of life, anxiety and fear of recurrence [ Time Frame: Assessed up at inclusion, 3 months after inclusion, 1 and 3 year after randomization ]
  3. Costs of treatment and follow-up [ Time Frame: Assessed up to 3 years ]
  4. Rate of patients without event at 5 years following randomization [ Time Frame: at 5 years following randomization ]
  5. Rate of patients without event at 3 and 5 years after randomization, according to the initial lymph node status [ Time Frame: at 3 and 5 years following randomization ]
  6. Recurrence rate (histologically proven) at three years following thyroidectomy [ Time Frame: at 3 years following randomization ]
  7. Rate of patients without event at 3 and 5 years after randomization, according to tumoral molecular characterization [ Time Frame: at 3 and 5 years following randomization ]
  8. Future of patients experiencing en event [ Time Frame: at 3 years after randomization ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with differentiated thyroid cancer (papillary, follicular or with Hurthle cells) in the absence of aggressive histological subtypes (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing or with an anaplastic component)
  2. Patients having undergone a total thyroidectomy with complete (R0) tumor resection, with or without lymph node neck dissection
  3. Total thyroidectomy performed 2 to 5 months before inclusion
  4. Patients with low risk of recurrence: pT1amN0 or pT1amNx with a sum of the size of the lesions above 1 cm and equal to or less than 2 cm, or pT1bN0 or pT1bNx (TNM 2010 classification). (Patients with less than 6 lymph nodes in the neck dissection will be classified as Nx)
  5. Post-operative neck ultrasound (performed 2 to 5 months after surgery) showing the absence of abnormalities in the lateral lymph node compartments, or if abnormalities, no lymph nodes with abnormal cytology and/or thyroglobulin concentration in the aspirate fluid > 10 ng/mL
  6. Age >=18 years
  7. Performance status of 0 or 1
  8. Patients who signed the informed consent
  9. Patients who can be followed-up annually during 5 years in order to assess the objectives of the study
  10. Women of childbearing age should have a negative pregnancy test before any radioiodine administration
  11. Both patients with or without thyroglobulin antibodies are eligible

Exclusion Criteria:

  1. Patients having undergone less than a total thyroidectomy
  2. Patients with aggressive histotype (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing, or with an anaplastic component)
  3. Patients having undergone surgery less than 2 months or more than 4 months before inclusion
  4. Patients with cancer classified as pT1a unifocal (in which ablation is not necessary), or pT1N1, pT2, pT3, pT4 or N1 (who have a higher risk of recurrence) (classification TNM 2010)
  5. Patient with known distant metastasis
  6. Abnormal post-operative neck ultrasound of the lateral lymph node compartments
  7. Patients with another malignancy not in remission for at least 2 years (except for in situ cervix uterine cancer, basocellular skin cancer)
  8. Patients with a recent history of drugs affecting thyroid function, including injection of radiocontrast agents during the last 8 weeks.
  9. Patients previously treated with radioactive iodine or who previously underwent a whole body scan with radioactive iodine
  10. Pregnant or breast feeding women
  11. Subject with any kind of disorder that may compromise his/her ability to give written informed consent and/or to comply with study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837745


Contacts
Contact: Sophie LEBOULLEUX, MD 0142114257 ext +33 sophie.leboulleux@igr.fr
Contact: Isabelle BORGET, MD 0142114146 ext +33 isabelle.borget@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Sophie LEBOULLEUX, MD    0142114257 ext +33    sophie.leboulleux@igr.fr   
Contact: Isabelle BORGET, MD    0142114146 ext +33    isabelle.borget@igr.fr   
Principal Investigator: Sophie LEBOULLEUX, MD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01837745     History of Changes
Other Study ID Numbers: 2012-A01569-34
2012/1913 ( Other Identifier: CSET number )
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms