ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Locally Advanced Nasopharyngeal Carcinoma

Treatments: Drug: Induction Chemotherapy; Drug: Concurrent Chemotherapy; Radiation: Definitive Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05062005

NCICCRTvCRT

Details and patient eligibility

About

This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether concurrent chemoradiotherapy is not inferior to induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.

Enrollment: 447 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-65 years old;
2. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;
3. Stage T3-4N0-1 (according to the UICC/AJCC 8th);
4. No distant metastasis;
5. Have not received anti-cancer treatment in the past;
6. ECOG (Eastern Cooperative Oncology Group of the United States): 0-1;
7. Adequate hematologic, hepatic and renal function.

Exclusion criteria

1. The purpose of treatment is palliative;
2. Diagnosed with other malignant tumors at the same time;
3. Malignant tumor history;
4. Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period;
5. Combined serious illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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447 participants in 2 patient groups

Induction Chemotherapy+Chemoradiotherapy

Other group

Treatment:

Drug: Concurrent Chemotherapy

Drug: Induction Chemotherapy

Radiation: Definitive Radiotherapy

Chemoradiotherapy

Other group

Treatment:

Drug: Concurrent Chemotherapy

Radiation: Definitive Radiotherapy