Clinical trial · Interventional
Gemcitabine - Oxaliplatin for Advanced Refractory Thyroid Cancer Patients: a Phase II Study
Open Labeled Phase II Study Evaluating Efficacy and Safety of Chemotherapy With Gemcitabine - Oxaliplatin Combination for Advanced Refractory Thyroid Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): inefficiency
Summary
Brief summary (as posted)
Radioiodine refractory differentiated thyroid cancer is a rare tumor and therapeutic options are limited in this setting. Molecular targeted therapies have recently been developed for progressive disease and demonstrated clinical activity, especially with anti-angiogenic agents. For patients with contra-indication to these agents or in case of progression or toxicity during treatment, chemotherapy is usually proposed but this strategy has not been validated by prospective data. The investigators propose to conduct an open single arm phase 2 study to evaluate response rate according to RECIST 1.1 with GEMOX regimen (gemcitabine - oxaliplatin combination) for advanced radioiodine refractory differentiated thyroid cancer patients after anti-angiogenic agents or in case of contra-indication to anti-angiogenic therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine -oxaliplatine combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gemcitabine -oxaliplatine combination
- interventionNames
- Drug: gemcitabine -oxaliplatine combination
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- 4 months
- description
- overall response rate measured (complete and partial responses) by CT-scan according to RECIST criteria v1.1
Secondary outcomes (7)
- measure
- number of adverse events and serious adverse events (AE) according to CTCAE v4.03
- timeFrame
- up to 12 month
- description
- recording number of adverse events and serious adverse events (AE) according to CTCAE v4.03, during chemotherapy and follow up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
"Main Inclusion criteria 1. Histologically confirmed differentiated or poorly differentiated thyroid cancer that is metastatic or unresectable 2. Patients refractory to radio iodine 3. Radiologic evidence of clinically relevant disease progression (as per RECIST 1.1) 4. Measurable disease (by RECIST Version 1.1 criteria) 5. ECOG performance status of ≤ 1 6. Adequate hematologic, renal and liver function 7. Negative serum pregnancy test in premenopausal women. 8. Signed informed consent Main Non-Inclusion criteria 1. Other histological subtypes of thyroid tumors: anaplastic, medullary, lymphoma or sarcoma 2. Active CNS metastases 3. Prior chemotherapy. Patients treated previously with molecular targeted therapies could be included. 4. Severe, acute or chronic medical or psychiatric condition or laboratory abnormality which in the judgment of the investigator would make the patient inappropriate for entry into this study"
References
Publications (0)
Data not yet available