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Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

ConditionsCisplatinCarboplatinNPC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorNanfang Hospital, Southern Medical University

About this trial

The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).

Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer edition).

No evidence of distant metastasis (M0).

Satisfactory performance status: Karnofsky scale (KPS) > 70.

Disqualifiers

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.

Age ≥65 years or <18 years.

Treatment with palliative intent.

Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Docetaxel,Carboplatin

    Drug

    Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.

  • Docetaxel,Cisplatin

    Drug

    Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy.

  • Carboplatin-based concurrent chemoradiotherapy

    Radiation

    Patients receive radical radiotherapy and carboplatin (AUC 5) every three weeks for three cycles during radiotherapy.

  • Cisplatin-based concurrent chemoradiotherapy

    Radiation

    Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Treatment groups

482 Participants
are divided into 2 treatment groups
Group A: CarboplatinExperimental treatment 2 interventions
Group B: CisplatinActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Failure-free survival

Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

Time frame
3-year

Secondary outcomes

1

Locoregional failure-free survival

Locoregional failure-free survival is calculated from randomisation to the first locoregional failure.

Time frame
3-year
2

Distant failure-free survival

Distant failure-free survival is calculated from randomisation to the first locoregional failure.

Time frame
3-year
3

The initial response rates after treatments

The initial response rates is calculated at the time 1 week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.

Time frame
A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.
4

Toxic effects

Radiation and chemotherapy related toxic effects as assessed by CTCAE v4.0.

Time frame
3-year

Other outcomes

Sponsors and contacts

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

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov
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