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

Last updated: May 6, 2023
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

3

Condition

Carcinoma

Nasopharyngeal Cancer

Treatment

3 cycles induction chemotherapy

2 cycles induction chemotherapy

Clinical Study ID

NCT05860868
Two VS Three
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 trialperiod;
  5. Combined serious illness.

Study Design

Total Participants: 474
Treatment Group(s): 2
Primary Treatment: 3 cycles induction chemotherapy
Phase: 3
Study Start date:
May 01, 2023
Estimated Completion Date:
May 31, 2030

Connect with a study center

  • First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Other (Non U.s.) 510080
    China

    Active - Recruiting

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