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NCT Number: NCT05062005

ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

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.

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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

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Shuang Wu, PHD

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

Induction chemotherapy

Drug

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.

Concurrent chemotherapy

Drug

Cisplatin 100 mg/m², Q3w.

Definitive radiotherapy

Radiation

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 year

    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.

Secondary outcomes

  1. OS (Overall Survival)

    Time frame: 3 year

    Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.

  2. LRFS (Locoregional Recurrence-free Survival)

    Time frame: 3 year

    Defined as the time from randomization to local or regional recurrence. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and recurrence free. Patients not having an event will be censored at the date last seen alive.

  3. DMFS (Distant Metastasis-free Survival)

    Time frame: 3 year

    Defined as the time of randomization to the appearance of distant metastasis. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and metastasis free. Patients not having an event will be censored at the date last seen alive.

  4. AE (Adverse events)

    Time frame: 3 year

    Adverse events during the treatment period will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Late AE of radiotherapy will be assessed according to RTOG criteria.

Study contacts

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

Shuang Wu, PHD

CONTACT

[email protected]

+862087755766

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Induction Chemotherapy+Chemoradiotherapy vs. Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2021
Registry last updated
Sep 30, 2021

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.

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