Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2032-11-30

Brief Summary

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To evaluate the locoregional control, survival rate, toxicity, and quality of life in patients with nasopharyngeal carcinoma treated with reduced prophylactic irradiation doses to the Low-Risk Clinical Target Volume (CTV).

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Detailed Description

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This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly diagnosed, untreated, non-distant metastatic, non-keratinizing nasopharyngeal carcinoma (NPC). The intervention involves comparing reduced-dose prophylactic irradiation to standard-dose prophylactic irradiation for the low-risk clinical target volume (CTV). The objective is to compare the locoregional control, survival rate, toxicity, and quality of life between the two groups.

Conditions

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Nasopharyngeal Cancinoma (NPC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reduced-dose Radiotherapy for Low-risk CTV

Group Type EXPERIMENTAL

Radiation Therapy

Intervention Type RADIATION

PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：42Gy/26Fr.

Standard-dose Radiotherapy for Low-risk CTV

Group Type ACTIVE_COMPARATOR

Radiation Therapy

Intervention Type RADIATION

PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：54Gy/33Fr.

Interventions

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Radiation Therapy

PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：42Gy/26Fr.

Intervention Type RADIATION

Radiation Therapy

PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：54Gy/33Fr.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

Newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; aged between 18 and 70 years; Eastern Cooperative Oncology Group performance score of 0-1; adequate hematologic function (neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥100×109/L, and hemoglobin≥ 90 g/L); adequate renal function (creatinine ≤ 1.5 upper limit of normal \[ULN\]) or calculated creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); and adequate hepatic function (serum bilirubin ≤ 2.0×ULN, and alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN).

Exclusion Criteria

Previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy (except for cured basal cell carcinoma or carcinoma in situ of the cervix); lactation or pregnancy; or severe coexisting illness.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No