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

Phase 3RecruitingNCT07201337

Sun Yat-sen University700 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

700

Conditions

Nasopharyngeal Cancinoma (NPC)

Interventions

Radiation TherapyRADIATION

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

Radiation TherapyRADIATION

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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. \-

Locations (6)

Dongguan People's Hospital

Dongguan, Guangdong, China

RECRUITING

Sun yat-sen university cancer center

Guangzhou, Guangdong, China

RECRUITING

Affiliated Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Outcomes

Primary Outcomes

Locoregional relapse-free survival

Defined as the time from randomization to either documented local and/or regional relapse or death from any cause (except for metastasis), whichever occurred first.

Time frame: 3 year

Secondary Outcomes

Overall survival

Defined as the time from randomization to death from any cause.

Time frame: 3 year

Failure-free survival

Defined as the time from randomisation to disease recurrence (distant metastasis or locoregional recurrence) or death due to any cause, whichever occurred first.

Time frame: 3 year

Distant metastasis-free survival

Defined as the time from randomization to documented distant metastasis or death from any cause (except for locoregional relapse).

Time frame: 3 year

Acute toxicities

Occur within 3 months after RT. Acute radiation-related toxicities are assessed using the National Cancer Institute Common Toxicity Criteria version 5.0 scale.

Time frame: 3 months

Late toxicities

Occur 3 months after RT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria

Time frame: 3 year

Patient's quality-of-life

Quality-of-life (QoL) scores were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire Core 30 items (QLQ-C30) version 3.0 and the head and neck cancer module (QLQ-H and N35).

Central Contacts

Hai-Qiang Mai, Ph. D.

CONTACT

+86-020-87343643 maihq@sysucc.org.cn

Data from ClinicalTrials.gov

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