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ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

ConditionLocally Advanced Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years old;

Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;

Stage T3-4N0-1 (according to the UICC/AJCC 8th);

No distant metastasis;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

447 Participants
are divided into 2 treatment groups
Group A: Induction Chemotherapy+ChemoradiotherapyOther 3 interventions
Group B: ChemoradiotherapyOther 2 interventions

Trial outcomes

Primary outcomes

1

FFS (Failure-free Survival)

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.

Time frame
3 year

Secondary outcomes

1

OS (Overall Survival)

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.

Time frame
3 year
2

LRFS (Locoregional Recurrence-free Survival)

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.

Time frame
3 year
3

DMFS (Distant Metastasis-free Survival)

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.

Time frame
3 year
4

AE (Adverse events)

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.

Time frame
3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov
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