Recruiting PHASE3 Cisplatin

New treatment option for Cisplatin

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

ClinicalTrials.gov ID: NCT03919552

What this study is testing

What is Docetaxel,Carboplatin?

Docetaxel,Carboplatin is an investigational medicine, being studied as a potential treatment for cisplatin.

Also referred to as TC induction chemotherapy.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 64

You may be able to join if

  • 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.
  • Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.

You likely can't join if

  • 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.
  • Pregnancy or lactation.
  • History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
See the full eligibility criteria
Who can join
  • 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.
  • Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
  • Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
  • Adequate renal function: creatinine clearance ≥60 ml/min.
  • Patients must be informed of the investigational nature of this study and give written informed consent.
What rules you out
  • 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.
  • Pregnancy or lactation.
  • History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor...

The study team makes the final eligibility decision.

Where it's taking place

  • Guangzhou, Guangdong, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.