Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Locally Advanced Nasopharyngeal Carcinoma

Treatments: Drug: 3 cycles induction chemotherapy; Drug: 2 cycles induction chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05860868

Two VS Three

Details and patient eligibility

About

This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether 2 cycles induction chemotherapy combined with concurrent chemoradiotherapy is not inferior to 3 cycles induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.

Enrollment: 474 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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474 participants in 2 patient groups

2 cycles

Experimental group

Description:

2 cycles induction + concurrent chemoradiotherapy

Treatment:

Drug: 2 cycles induction chemotherapy

3 cycles

Active Comparator group

Description:

3 cycles induction + concurrent chemoradiotherapy

Treatment:

Drug: 3 cycles induction chemotherapy