Clinical trial · Interventional
Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer
Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer: A Randomized, Controlled, Non-inferiority, Phase 2 Study
NCT07777536CI-TRIAL-00123044recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore the efficacy and safety of selective coverage radiotherapy in poorly differentiated and anaplastic thyroid cancer
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| comprehensive coverage radiotherapy | Radiation | — | UNRESOLVED |
| Selective coverage radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Selective coverage radiotherapy
- interventionNames
- Radiation: Selective coverage radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- comprehensive coverage radiotherapy
- interventionNames
- Radiation: comprehensive coverage radiotherapy
Primary outcomes (1)
- measure
- Locoregional control rate，LRC
- timeFrame
- 12 months
- description
- The time from the randomization date to the first occurrence of locoregional progression/recurrence. Locoregional regions include the primary thyroid lesion or the postoperative tumor bed, the central region/upper mediastinal related regions, the cervical lymph node region, the retropharyngeal lymph nodes, and the cervical soft tissue contiguous with the original lesion. 12-month LRC is defined as 1 minus the cumulative incidence of locoregional progression over 12 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old * Pathologically confirmed as ATC, thyroid cancer containing ATC components, PDTC (in accordance with Turin criteria), or other thyroid cancers with poorly differentiated components, and the MDT considers the biological behavior similar to PDTC. * Evaluated by the MDT and proposed to receive external beam radiotherapy, including postoperative R0/R1, R2 gross residual, inoperable local lesion, and local recurrence. * ECOG performance status 0-2 * expected survival ≥ 3 months * major organ functions can meet the requirements for radiotherapy and the proposed systemic treatment. * The subject voluntarily participates in the study and signs a written informed consent form, willing to follow up according to the protocol and fill in the quality of life scale. Exclusion Criteria: * Has received radiotherapy to the head and neck or upper mediastinum region in the past, and the target area of this study overlaps significantly with it, and the normal tissue limit cannot be met. * Has severe uncontrolled infections, active bleeding, unaddressed airway crises, severe dysfunction of the heart, lungs, liver, kidneys or other diseases that cannot be safely treated with radiotherapy. * Pregnant or lactating women; women of childbearing age who do not agree to take effective contraceptive measures. * Has other active malignant tumors within 5 years or simultaneously (excluding cured localized tumors such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc.) * Cannot complete radiotherapy fixation, simulation positioning or follow-up imaging assessment. * Other situations that the researcher deems unsuitable for participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.