Sorafenib as adjuvant to radioiodine therapy in non-medullary thyroid carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002365-13-NL

Enrollment

Registered

2007-05-11

Start date

2007-06-29

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-medullary thyroid carcinoma

Interventions

Trade Name: Nexavar Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · Patients with non-medullary thyroid carcinoma · The patients must have undergone total thyroidectomy · Presence of metastases or inoperable recurrent disease, as proven by elevated serum thyroglobulin levels (Tg) in combination with radiological evidence for tumor. · No or insufficient RaI uptake in tumor as proven by RaI scintigraphy, performed after prior RaI therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: · Pregnancy · Other active malignancies · Active kidney, liver or pancreatic disease or dysfunction · Unstable angina pectoris or recent (<3 months) myocardial infarction. · Coagulopathy

Design outcomes

Primary

Measure	Time frame
Main Objective: The PRIMARY OBJECTIVE is to study the beneficial effects of Sorafenib in patients with non-medullary thyroid carcinoma with active tumor that does not accumulate RaI sufficiently on: · Reinduction of RaI uptake · Tumor progression ;Secondary Objective: The SECONDARY OBJECTIVE is to study the additional beneficial effects of RaI therapy with 6000 MBq 131I on tumor progression after reinduction of RaI uptake with Sorafenib. ;Primary end point(s): 1. Reinduction of RaI uptake by RaI scintigraphy: The appearance of one or more RaI accumulating lesions at RaI scintigraphy, planar images and/or SPECT (see below) 2. Serum thyroglobulin levels: The absence of progression: no statistically significant positive slope at linear regression of the log-transformed serum Tg levels, measured at 0, 4, 8, 12, 16, 20, 24 and 28 weeks after start of Sorafenib: a. Stable disease: The slope at linear regression of the log-transformed serum Tg levels, measured at 0, 4, 8, 12, 16, 20, 24 and 28 weeks after start of Sorafenib is not significantly different from 0 ln ug/Ltime OR b. Response: The slope at linear regression of the log-transformed serum Tg levels is negative (statistically significantly below 0 ln ug/Ltime). 3. CT Imaging: The absence of progression according to RECIST criteria: a. Stable disease—neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. b. Partial response—at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; c. Complete response: the disappearance of all target lesions;	—

Measure

Time frame

Main Objective: The PRIMARY OBJECTIVE is to study the beneficial effects of Sorafenib in patients with non-medullary thyroid carcinoma with active tumor that does not accumulate RaI sufficiently on: · Reinduction of RaI uptake · Tumor progression ;Secondary Objective: The SECONDARY OBJECTIVE is to study the additional beneficial effects of RaI therapy with 6000 MBq 131I on tumor progression after reinduction of RaI uptake with Sorafenib. ;Primary end point(s): 1. Reinduction of RaI uptake by RaI scintigraphy: The appearance of one or more RaI accumulating lesions at RaI scintigraphy, planar images and/or SPECT (see below) 2. Serum thyroglobulin levels: The absence of progression: no statistically significant positive slope at linear regression of the log-transformed serum Tg levels, measured at 0, 4, 8, 12, 16, 20, 24 and 28 weeks after start of Sorafenib: a. Stable disease: The slope at linear regression of the log-transformed serum Tg levels, measured at 0, 4, 8, 12, 16, 20, 24 and 28 weeks after start of Sorafenib is not significantly different from 0 ln ug/L*time OR b. Response: The slope at linear regression of the log-transformed serum Tg levels is negative (statistically significantly below 0 ln ug/L*time). 3. CT Imaging: The absence of progression according to RECIST criteria: a. Stable disease—neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. b. Partial response—at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; c. Complete response: the disappearance of all target lesions;

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026