Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144079
Status:
COMPLETED
Last Update Posted:
2006-05-09
First Post:
2005-09-01
Brief Title:
Multicenter Study Differentiated Thyroid Carcinoma
Sponsor:
University Hospital Muenster
Organization:
University Hospital Muenster
Study Overview
Official Title:
Phase 3 Trial of Adjuvant External Beam Radiotherapy for Locally Invasive Differentiated Thyroid Carcinoma
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The trial examines the clinical benefit of adjuvant external beam radiotherapy RTx for locally invasive differentiated carcinoma TNM stages pT4 pN01x M0x 5th ed 1997 of the thyroid gland DTC Patients are treated with surgery thyroidectomy and lymphadenectomy radioiodine therapy RIT to ablate the thyroid remnant tissue and TSH-suppressive L-thyroxine therapy with or without RTx after documented elimination of cervical I-131 uptake
Detailed Description:
MSDS was designed as a comprehensive cohort trial with randomization and observation arms Patients are enrolled at the time of the first ablative radioiodine therapy RIT Inclusion criteria are papillary or follicular DTC pT4 pN01x M0x age between 18 incl and 70 years excl at the time of initial surgery completion of primary surgical therapy with R0 no tumor residues or R1 microscopic residues resection Karnofsky index of at least 70 freedom from distant metastases at the time of initial radioiodine therapy RIT and informed patient consent Criteria for exclusion are secondary malignancy except basalioma pregnancy serious general disease serious psychiatric disorder inability to give informed consent previous RTx and recurrence of previous DTC From 2003 the first inclusion criterion was changed into DTC pT34 pN01x M0x to reflect the 2002 revision of the TNM staging system
The treatment protocol is in accordance with current guidelines in Germany and includes total thyroidectomy TT with central lymphadenectomy LNA RIT to ablate the thyroid remnant and TSH-suppressive therapy with L-thyroxine TSH 01 mUl RIT is administered under endogenous TSH-stimulation after 4 weeks cessation of L-thyroxine using standard activities of 1-4 and 1-2 GBq I-131 in patients with a 24-h-I-131 uptake below 10 and 10-20 resp or individual dosimetry aiming for at least 300 Gy in the thyroid remnant If scintigraphic I-131 uptake by the thyroid remnant persists at whole-body scintigraphy at least 200 MBq at least 48 h 3 months after RIT a second fraction of RIT is given with 4-10 GBq
Patients who consented to randomization at centers actively taking part in randomization were randomized to treatment arms A additional adjuvant RTx and B no RTx 3 months after initial RIT after confirmation of the histological diagnosis by the reference pathologist and when distant metastases had been excluded by means of serum thyroglobulin Tg WBS s a and a native thoracic computed tomogram CCT Randomization was stratified according to histological type papillary v follicular nodal status pN01x and participating center and performed by an operator-independent randomization routine embedded in the database The remaining patients were assigned to arms A and B by the participating centers
RTx is begun after documented elimination of cervical I-131 uptake in a I-131 WBS 3 months after the last fraction of ablative RIT RT includes the thyroid bed in unilateral tumors only the affected side with a dose of 594 Gy and 666 Gy after R0 and R1 resection resp and the regional lymph nodes of the neck and upper mediastinum including the posterior cervical chain from the mandible and mastoid process to the tracheal bifurcation with a dose of 504 Gy and 540 Gy in pN0 and pN1x disease resp Fractionation is conventional 18 Gyd 5 days a week 3-D planning according to IRCU 50 is mandatory
Patient follow-up includes as a minimum out-patient appointments with cervical ultrasound and measurement of serum TSH hTG anti-Tg antibodies and a blood count 2 and 8 months after each RIT or WBS and a WBS with at least 200 MBq over at least 48 h under endogenous TSH-stimulation 3 and 12 months after ablative RIT and then at 24-month intervals FDG-PET and other imaging modalities can be performed if needed At each follow-up appointment RTx toxicity is recorded according to RTOG criteria and quality of life by the QLQ-C30 questionnaire v 30 German of the EORTC
The treatment protocol is in accordance with current guidelines in Germany and includes total thyroidectomy TT with central lymphadenectomy LNA RIT to ablate the thyroid remnant and TSH-suppressive therapy with L-thyroxine TSH 01 mUl RIT is administered under endogenous TSH-stimulation after 4 weeks cessation of L-thyroxine using standard activities of 1-4 and 1-2 GBq I-131 in patients with a 24-h-I-131 uptake below 10 and 10-20 resp or individual dosimetry aiming for at least 300 Gy in the thyroid remnant If scintigraphic I-131 uptake by the thyroid remnant persists at whole-body scintigraphy at least 200 MBq at least 48 h 3 months after RIT a second fraction of RIT is given with 4-10 GBq
Patients who consented to randomization at centers actively taking part in randomization were randomized to treatment arms A additional adjuvant RTx and B no RTx 3 months after initial RIT after confirmation of the histological diagnosis by the reference pathologist and when distant metastases had been excluded by means of serum thyroglobulin Tg WBS s a and a native thoracic computed tomogram CCT Randomization was stratified according to histological type papillary v follicular nodal status pN01x and participating center and performed by an operator-independent randomization routine embedded in the database The remaining patients were assigned to arms A and B by the participating centers
RTx is begun after documented elimination of cervical I-131 uptake in a I-131 WBS 3 months after the last fraction of ablative RIT RT includes the thyroid bed in unilateral tumors only the affected side with a dose of 594 Gy and 666 Gy after R0 and R1 resection resp and the regional lymph nodes of the neck and upper mediastinum including the posterior cervical chain from the mandible and mastoid process to the tracheal bifurcation with a dose of 504 Gy and 540 Gy in pN0 and pN1x disease resp Fractionation is conventional 18 Gyd 5 days a week 3-D planning according to IRCU 50 is mandatory
Patient follow-up includes as a minimum out-patient appointments with cervical ultrasound and measurement of serum TSH hTG anti-Tg antibodies and a blood count 2 and 8 months after each RIT or WBS and a WBS with at least 200 MBq over at least 48 h under endogenous TSH-stimulation 3 and 12 months after ablative RIT and then at 24-month intervals FDG-PET and other imaging modalities can be performed if needed At each follow-up appointment RTx toxicity is recorded according to RTOG criteria and quality of life by the QLQ-C30 questionnaire v 30 German of the EORTC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Deutsche Krebshilfe 70-2294 | None | None | None |