Thyroid Cancer
Conditions
Keywords
poorly differentiated thyroid cancer, anaplastic thyroid cancer, selective coverage radiotherapy, locoregional control, radiotherapy-related toxicity
Brief summary
To explore the efficacy and safety of selective coverage radiotherapy in poorly differentiated and anaplastic thyroid cancer
Detailed description
To explore that selective coverage radiotherapy is non-inferior to comprehensive coverage radiotherapy in terms of locoregional control rate at 12 months in poorly differentiated and anaplastic thyroid cancer, while reducing radiotherapy-related toxicity and improving quality of life.
Interventions
RADIATIONSelective coverage radiotherapy
1. GTV or GTV tb 66-70Gy/33-35Fx 2. High-risk CTV 60Gy: Expand the GTV/GTVtb by 10 mm and adjust according to the anatomical barriers, pre-treatment area were involved if received systemic treatment before radiotherapy；The lymphatic drainage areas where the positive lymph nodes are located, can also be regarded as high-risk CTVs according to MDT decision.
RADIATIONcomprehensive coverage radiotherapy
1. GTV or GTV tb 66-70Gy/33-35Fx 2. CTV: Expand the GTV/GTVtb by 10 mm and adjust according to the anatomical barriers, pre-treatment area were involved if received systemic treatment before radiotherapy（60 Gy）；prophylactic irradiation was performed on the bilateral neck II-VI regions and upper mediastinum regions based on the extent of lymph node invasion, and the dose was determined according to the risk stratification（54-60Gy）.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional control rate，LRC | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival，PFS | 12 months | From the date of randomization to the date of the first recording of tumor PD (evaluated according to the RECIST 1.1) or the date of death due to any cause, whichever comes earlier. PD includes local regional recurrence/progression and distant metastasis. |
| Overall Survival, OS | 12 months | The time from randomization to death due to any cause. |
| Disease Control Rate，DCR | up to 12 months | Defined as the proportion of patients with a complete response, partial response and stable Disease to radiotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST). Applicable to those with measurable lesions. |
| Adverse Events | 12 months | All radiotherapy-related adverse events will be documented |
| Quality of Life (QoL) by EORTC QLQ-H&N35 questionnaire. | 12 months | Changes in QoL of participants from baseline to up to 12 months after the radiotherapy. Use EORTC QLQ-H\&N35 questionnaire. |
Countries
China
Contacts
CONTACTXiayun He, MD
CONTACTFen Xue, MD
Outcome results
None listed