Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05860868

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

First Affiliated Hospital, Sun Yat-Sen University

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

Location status: Recruiting

Location contact

Cheng-Tao Wang

CONTACT

[email protected]

+862087755766

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

2 cycles induction chemotherapy

Drug

Drug: 2 cycles Induction Chemotherapy Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w.

Drug: Concurrent Chemotherapy Cisplatin 100 mg/m², Q3w.

Radiation: Definitive Radiotherapy For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).

3 cycles induction chemotherapy

Drug

Drug: 3 cycles Induction Chemotherapy Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w.

Drug: Concurrent Chemotherapy Cisplatin 100 mg/m², Q3w.

Radiation: Definitive Radiotherapy For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).

Primary outcomes

  1. FFS, Failure Free Survival

    Time frame: 3 years

    Defined as the time from randomization to tumor recurrence, distant metastasis, or death due to any reason, whichever occurs first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng-Tao Wang

CONTACT

[email protected]

+862087755766

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
May 16, 2023
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.