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Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response

ConditionNasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University

About this trial

This is an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial aimed to investigate the impact of reduced-dose radiotherapy in combination with chemotherapy and immunotherapy on patients' prognosis and complication compared with conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 Years to 65 Years;

Eastern Cooperative Oncology Group performance status ≤1;

Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma, the pathological type is non-keratinising carcinoma;

Tumor staged as Stage III (T3N0 Excepted; AJCC 8th);

Disqualifiers

Hepatitis B virus surface antigen (HBsAg) positive and Hepatitis B virus DNA > 1000 copies/ml;

Anti-hepatitis C virus positive;

Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS);

Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment, history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved;

Trial design

Design model

Parallel

Treatments tested in this trial

  • PD-1 blocking antibody

    Drug

    1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC. 2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1.

  • Gemcitabine

    Drug

    Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.

  • Cisplatin (80 mg/m2)

    Drug

    Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.

  • Reduced-dose Intensity-modulated radiotherapy

    Radiation

    1. Definitive IMRT, 30 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6360cGy/30F; pCTV1: 5460cGy/30F; pCTV2: 4920cGy/30F.

  • Conventional-dose Intensity-modulated radiotherapy

    Radiation

    1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F.

  • Cisplatin (100 mg/m2)

    Drug

    Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles

  • Capecitabine

    Drug

    Metronomic adjuvant capecitabine chemotherapy: 650 mg/m2 p.o. bid, 1 year, adminstration starts immediately after concurrent chemoradiotherapy.

Treatment groups

593 Participants
are divided into 3 treatment groups
Group A: Reduced-dose radiotherapy groupExperimental treatment 5 interventions
Group B: Conventional-dose radiotherapy groupActive comparator 5 interventions
Group C: Not-Randomized populationOther 6 interventions

Trial outcomes

Primary outcomes

1

Locoregional failure-free survival (LRFFS)

Locoregional failure-free survival is measured from day of diagnosis until local or regional recurrence.

Time frame
3-year

Secondary outcomes

1

Overall survival (OS)

Overall survival is measured from day of diagnosis until death from any cause.

Time frame
3 year
2

Failure-free survival (FFS)

Failure-free survival is measured from day of diagnosis until local recurrence, regional recurrence, distant failure, or death from any cause, whichever occurred first.

Time frame
3 year
3

Distant failure-free survival (DFFS)

Distant failure-free survival is measured from day of diagnosis until distant failure.

Time frame
3 year
4

Local failure-free survival (LFFS)

Local failure-free survival is measured from day of diagnosis until local recurrence.

Time frame
3 year

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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