Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

To explore the efficacy and safety of selective coverage radiotherapy in poorly differentiated and anaplastic thyroid cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Selective coverage radiotherapy

    Radiation

    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.

  • comprehensive coverage radiotherapy

    Radiation

    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).

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Selective coverage radiotherapyExperimental treatment 1 intervention
Group B: comprehensive coverage radiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Locoregional control rate,LRC

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.

Time frame
12 months

Secondary outcomes

1

Progression Free Survival,PFS

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.

Time frame
12 months
2

Overall Survival, OS

The time from randomization to death due to any cause.

Time frame
12 months
3

Disease Control Rate,DCR

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.

Time frame
up to 12 months
4

Adverse Events

All radiotherapy-related adverse events will be documented

Time frame
12 months

Other outcomes

Sponsors and contacts

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