RecruitingPhase 3NCT06092957

Reduced-dose RT With/Without CCT Versus Standard CCRT for High-risk LANPC Who Achieved CR Post Induction Chemotherapy

Reduced-dose Radiotherapy With/Without Concurrent Chemotherapy Versus Standard Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma Who Achieved Complete Response After Induction Chemotherapy Plus Immunotherapy: a Randomized, Open-label, Multicenter, Phase III Trial


Sponsor

Sun Yat-sen University

Enrollment

504 participants

Start Date

Oct 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This prospective trial aims to enroll patients with high-risk stage III-IVA (AJCC 8th, except T3N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved both radiological and biological complete response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1:1 ratio to receive reduced-dose radiotherapy (60Gy/30F) alone or reduced-dose radiotherapy plus concurrent chemotherapy or standard dose radiotherapy (70Gy/33F) with concurrent chemotherapy. To solve the urgent problem of whether patients with high-risk advanced nasopharyngeal carcinoma are suitable for downgrade treatment.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether patients with locally advanced nasopharyngeal carcinoma (cancer at the back of the nasal cavity) who respond exceptionally well to initial chemotherapy and immunotherapy can be treated with a lower dose of radiation — either with or without additional chemotherapy — compared to the standard, higher-dose treatment. **You may be eligible if...** - You have been diagnosed with nasopharyngeal carcinoma (a specific type of throat/nasal cancer) - Your cancer is stage III or IVA - After 3 cycles of platinum-based chemotherapy plus immunotherapy, imaging, biopsy, and a blood test (EBV DNA) all confirm complete remission - You are in reasonably good health (ECOG 0-1) - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You did not achieve complete remission after initial treatment - You have serious infection, autoimmune disease, or other major illnesses - You have had prior radiation to the head and neck area - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCisplatin-based induction chemotherapy

Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy including GP, TP, and TPF regimen.

DRUGFull course of PD-1/PD-L1 blockades

a) Camrelizumab 200mg, b) Toripalimab 240mg, or c) Adebrelimab 1200mg will be started on day 1 of induction chemotherapy and given every 3 weeks for up to 12 cycles, or until intolerable toxicity, or disease progression or withdrawal from the treatment.

RADIATIONReduced-dose IMRT

GTVnx:60Gy/30F/2.0Gy,CTV1:54Gy/30F/1.8Gy,CTV2:48Gy/30F/1.6Gy

RADIATIONStandard-dose IMRT

GTVnx:69.96Gy/33Fr/2.12Gy;CTV1:60.60Gy/33Fr/1.82y;CTV2:54.12Gy/33Fr/1.64Gy

DRUGConcurrent Chemotherapy

Cisplatin 100mg/m2 every 3 weeks for 2 cycles


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06092957


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