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Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up (INTERMEDIATE)

Primary Purpose

Thyroid Cancer, Intermediate Risk

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Systematic RAI-treatment
Decision of RAI-treatment guided by a post-operative assessment
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring radioiodine, I131

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subgroup of patients with differentiated thyroid cancer and intermediate-risk defined as follows according to TNM 2017:

    • Papillary thyroid cancer (PTC) without aggressive subtype, follicular thyroid cancer (FTC) (with < 4 foci of vascular invasion) or Hürthle cell carcinoma (HCC)
    • T1b or T2 with minimal extra-thyroid extension into the perithyroidal soft tissues and/or pN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10
    • T1aN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10
  • Patient treated by total thyroidectomy with macroscopically complete tumor resection (R0 or R1) ± neck dissection
  • Total thyroidectomy performed within 6 to 14 10 weeks before randomization
  • Patient with or without anti-thyroglobulin antibodies (TgAb)
  • No known distant metastases
  • Normal post-operative neck ultrasound (US) or if doubtful US, negative cytology and normal Tg value (<10 ng/ml) in FNA washout fluid
  • Post-operative LT4 treatment initiated at least 6 weeks before randomization
  • Performance Status 0 or 1
  • Patients aged 18 years or older
  • Signed informed consent form
  • Patient who agrees to be followed annually during 5 years
  • Patient affiliated to the French social security system

Exclusion Criteria:

  • • Patients with:

    • medullary or anaplastic thyroid cancer
    • or poorly differentiated carcinoma
    • or well differentiated FTC with at least more than 4 foci of vascular invasion
    • or PTC with aggressive variants (tall cell or columnar cell carcinoma, diffuse sclerosing papillary, hobnail variant)

    • NIFTP (Noninvasive follicular thyroid neoplasm with papillary-like nuclear features)

      • Low-risk or high-risk DTC patients according to ATA 2015, and intermediate-risk patients with extra-thyroid extension into the perithyroidal muscles (pT3b according to pTNM 2017), and/or pN1 with nodal largest dimension >10 mm or with extra-capsular invasion or more than 10 metastatic nodes. This excludes the following patients:

    • All pT1a, pT3 or pT4
    • pT1aN0/x with or without minimal extra-thyroid extension
    • pT1bN0/x, pT2N0/Nx without minimal extra-thyroid extension
    • pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension <2mm
    • pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension >10mm
    • pT2N0/Nx without extra-thyroid extension
    • pT2N1 without extra-thyroid extension and with nodal largest dimension <2mm
    • pT2N1 without extra-thyroid extension and with nodal largest dimension >10mm

    • Surgery considered as macroscopically incomplete (R2)

      • Patients who have undergone lobectomy only
      • Post-operative neck US with metastatic lymph-nodes confirmed by cytology or by increased Tg (>10 ng/ml) in FNA washout fluid
      • Drugs affecting thyroid function including iodinated contrast agents in the 6 weeks prior to randomization. Amiodarone should have been stopped at least 1 year before randomization.
      • Previous RAI treatment for thyroid cancer
      • Pregnant or lactating women
      • Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study
      • Patient deprived of liberty or placed under the authority of a tutor
      • History of malignancy in the past 3 years, except skin cancer excluding melanoma, carcinoma in situ of the cervix. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and not have shown signs of recurrence for at least 3 years

Sites / Locations

  • CHU Pointe à pitre
  • Chu AngersRecruiting
  • Institu de Cancérologie de l'Ouest - Site AngersRecruiting
  • BergoniéRecruiting
  • Hôpital saint-AndréRecruiting
  • Chu BrestRecruiting
  • Centre Francois BaclesseRecruiting
  • Centre Hospitalier Métropôle SavoieRecruiting
  • Centre Jean PerrinRecruiting
  • Centre Georges-François LeclercRecruiting
  • Chu GrenobleRecruiting
  • Chru LilleRecruiting
  • Centre Léon BérardRecruiting
  • Chu Lyon,
  • CHU TimoneRecruiting
  • Chu NancyRecruiting
  • Chu NantesRecruiting
  • Centre Antoine Lacassagne -Recruiting
  • Chu NimesRecruiting
  • AP-HP Pitié SalpétrièreRecruiting
  • Centre Jean GodinotRecruiting
  • Centre Henri BecquerelRecruiting
  • Institut CURIE, site Réné HugueninRecruiting
  • Institu de Cancérologie de l'Ouest - Site St HerblainRecruiting
  • Centre Paul StraussRecruiting
  • CHU TOULOUSE, Hôpital LarreyRecruiting
  • IUCT OncopoleRecruiting
  • Institut Gustave RoussyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RAI group

GUIDED FOLLOW-UP group

Arm Description

Outcomes

Primary Outcome Measures

the rate of patients with excellent tumoral response
normal neck ultrasonography and Tg/LT4 <0.2 ng/mL and absence of TgAb and if performed, no abnormalities on other imaging modalities

Secondary Outcome Measures

Patient's quality-of-life
Comparison of the scores on SF-36 (score between 0 and 100) between 2 arms
Salivary, nasal and lachrymal toxicities
Comparison of the intensity of salivary, nasal and lachrymal toxicities between 2 arms
Management cost
Costs of all medical exams and transportation related to the care within 5 years post-randomization in both groups
Patient's anxiety
Comparison of the scores on STAI questionnaire (score between 20 and 80) between 2 arms

Full Information

First Posted
February 20, 2020
Last Updated
September 6, 2023
Sponsor
Centre Francois Baclesse
Collaborators
French cancer Institute INCa
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1. Study Identification

Unique Protocol Identification Number
NCT04290663
Brief Title
Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up
Acronym
INTERMEDIATE
Official Title
Multicentric Phase III Trial Comparing Two Strategies in Intermediate-risk Differentiated Thyroid Cancer Patients: Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up Based on Serum Tg Values and Diagnostic RAI Scintigraphy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
February 2031 (Anticipated)
Study Completion Date
February 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
French cancer Institute INCa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Intermediate Risk
Keywords
radioiodine, I131

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
476 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RAI group
Arm Type
Active Comparator
Arm Title
GUIDED FOLLOW-UP group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Systematic RAI-treatment
Intervention Description
Administration of 3.7 GBq (100 mCi) or 1,1 GBq (30 mCi) of I131 at the choice of the investigator after rhTSH-stimulation
Intervention Type
Other
Intervention Name(s)
Decision of RAI-treatment guided by a post-operative assessment
Intervention Description
The decision-making for the administration of an adapted RAI-treatment will be taken according to the following criteria: No RAI treatment if Tg/LT4 ≤1 ng/mL and rhTSH-sTg ≤10 ng/mL and normal diagnostic RAI-scintigraphy 1.1 GBq after rhTSH if Tg/LT4>1 ng/mL or rhTSH-sTg>10 ng/mL and normal diagnostic RAI-scintigraphy. 3.7 GBq after rhTSH if metastatic lymph-node(s) detected on diagnostic RAI-scintigraphy without distant metastasis 3.7 GBq after hormone withdrawal if distant metastasis detected on diagnostic RAI-scintigraphy or on the hybrid CT scan of the SPECT-CT acquisition
Primary Outcome Measure Information:
Title
the rate of patients with excellent tumoral response
Description
normal neck ultrasonography and Tg/LT4 <0.2 ng/mL and absence of TgAb and if performed, no abnormalities on other imaging modalities
Time Frame
36 months after randomization
Secondary Outcome Measure Information:
Title
Patient's quality-of-life
Description
Comparison of the scores on SF-36 (score between 0 and 100) between 2 arms
Time Frame
During I131 treatment and at 1 and 3 years
Title
Salivary, nasal and lachrymal toxicities
Description
Comparison of the intensity of salivary, nasal and lachrymal toxicities between 2 arms
Time Frame
During I131 treatment and at 1,2,3 and 5 years
Title
Management cost
Description
Costs of all medical exams and transportation related to the care within 5 years post-randomization in both groups
Time Frame
through study completion, an average of 5 years
Title
Patient's anxiety
Description
Comparison of the scores on STAI questionnaire (score between 20 and 80) between 2 arms
Time Frame
During I131 treatment and at 1 and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subgroup of patients with differentiated thyroid cancer and intermediate-risk defined as follows according to TNM 2017: Papillary thyroid cancer (PTC) without aggressive subtype, follicular thyroid cancer (FTC) (with < 4 foci of vascular invasion) or Hürthle cell carcinoma (HCC) T1b or T2 with minimal extra-thyroid extension into the perithyroidal soft tissues and/or pN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10 T1aN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10 Patient treated by total thyroidectomy with macroscopically complete tumor resection (R0 or R1) ± neck dissection Total thyroidectomy performed within 6 to 14 10 weeks before randomization Patient with or without anti-thyroglobulin antibodies (TgAb) No known distant metastases Normal post-operative neck ultrasound (US) or if doubtful US, negative cytology and normal Tg value (<10 ng/ml) in FNA washout fluid Post-operative LT4 treatment initiated at least 6 weeks before randomization Performance Status 0 or 1 Patients aged 18 years or older Signed informed consent form Patient who agrees to be followed annually during 5 years Patient affiliated to the French social security system Exclusion Criteria: • Patients with: medullary or anaplastic thyroid cancer or poorly differentiated carcinoma or well differentiated FTC with at least more than 4 foci of vascular invasion or PTC with aggressive variants (tall cell or columnar cell carcinoma, diffuse sclerosing papillary, hobnail variant) NIFTP (Noninvasive follicular thyroid neoplasm with papillary-like nuclear features) • Low-risk or high-risk DTC patients according to ATA 2015, and intermediate-risk patients with extra-thyroid extension into the perithyroidal muscles (pT3b according to pTNM 2017), and/or pN1 with nodal largest dimension >10 mm or with extra-capsular invasion or more than 10 metastatic nodes. This excludes the following patients: All pT1a, pT3 or pT4 pT1aN0/x with or without minimal extra-thyroid extension pT1bN0/x, pT2N0/Nx without minimal extra-thyroid extension pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension <2mm pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension >10mm pT2N0/Nx without extra-thyroid extension pT2N1 without extra-thyroid extension and with nodal largest dimension <2mm pT2N1 without extra-thyroid extension and with nodal largest dimension >10mm Surgery considered as macroscopically incomplete (R2) Patients who have undergone lobectomy only Post-operative neck US with metastatic lymph-nodes confirmed by cytology or by increased Tg (>10 ng/ml) in FNA washout fluid Drugs affecting thyroid function including iodinated contrast agents in the 6 weeks prior to randomization. Amiodarone should have been stopped at least 1 year before randomization. Previous RAI treatment for thyroid cancer Pregnant or lactating women Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study Patient deprived of liberty or placed under the authority of a tutor History of malignancy in the past 3 years, except skin cancer excluding melanoma, carcinoma in situ of the cervix. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and not have shown signs of recurrence for at least 3 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane BARDET, MD
Phone
(33)231455050
Email
s.bardet@baclesse.unicancer.fr
Facility Information:
Facility Name
CHU Pointe à pitre
City
Pointe À Pitre
State/Province
Guadeloupe
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzy DUFLO, Prof
Facility Name
Chu Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice RODIEN, MD
Facility Name
Institu de Cancérologie de l'Ouest - Site Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier MOREL, MD
Facility Name
Bergonié
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann GODBERT, MD
Facility Name
Hôpital saint-André
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan NICOLESCU-CATARGI, Prof
Facility Name
Chu Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie ROUDAUT, MD
Facility Name
Centre Francois Baclesse
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane BARDET, MD
Facility Name
Centre Hospitalier Métropôle Savoie
City
Chambéry
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Cyril BOURRE, MD
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clémence VALLA, MD
Facility Name
Centre Georges-François Leclerc
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inna DYGAI-COCHET, MD
Facility Name
Chu Grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie ROUX, MD
Facility Name
Chru Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine DO CAO, MD
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Laure GIRAUDET, MD
Facility Name
Chu Lyon,
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline MOREAU TRIBY, MD
Facility Name
CHU Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David TAIEB, Prof
Facility Name
Chu Nancy
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc KLEIN, prof
Facility Name
Chu Nantes
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Ansquer, MD
Facility Name
Centre Antoine Lacassagne -
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle BENISVY, MD
Facility Name
Chu Nimes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier GILLY, MD
Facility Name
AP-HP Pitié Salpétrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte LUSSEY-LEPOUTRE, MD
Facility Name
Centre Jean Godinot
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad ZALZALI, MD
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agathe EDET-SANSON, MD
Facility Name
Institut CURIE, site Réné Huguenin
City
Saint-Cloud
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RICHARD Capucine, MD
Facility Name
Institu de Cancérologie de l'Ouest - Site St Herblain
City
Saint-Herblain
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danièla RUSU, MD
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier SCHNEEGANS, MD
Facility Name
CHU TOULOUSE, Hôpital Larrey
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Solange GRUNENWALD, MD
Facility Name
IUCT Oncopole
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Slimane ZERDOUD, MD
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Livia LAMARTINA, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up

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