Actively Recruiting

Phase 3
Age: 18Years - 64Years
All Genders
ID03919552

Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 3 Trial

Led by Nanfang Hospital, Southern Medical University · Updated on 2023-06-18

482

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two types of chemoradiotherapy—cisplatin-based and carboplatin-based—in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). This phase 3 trial focuses on patients with non-keratinizing NPC at specific tumor stages without distant metastasis. The goal is to confirm the value of carboplatin-based treatment in this patient group. Patients are randomly assigned to receive either cisplatin or carboplatin chemotherapy combined with docetaxel before undergoing radical radiotherapy. The investigational group receives docetaxel and carboplatin every three weeks for two cycles before radiotherapy, then carboplatin concurrently with radiotherapy for three cycles. The control group receives docetaxel and cisplatin before radiotherapy, then cisplatin with radiotherapy for three cycles. Treatment doses and schedules are specified for each regimen. Participants will be monitored for their survival without treatment failure over three years, along with other outcomes like distant and locoregional relapse, response rates after treatments, and side effects. Evaluations occur at set intervals after chemotherapy and radiotherapy completion. Safety is assessed in those receiving assigned treatments, with all analyses performed on an intention-to-treat basis. The study duration extends through 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with newly confirmed non-keratinizing nasopharyngeal carcinoma
  • Tumor staged as T3-4Nx or TxN2-3 without distant metastasis (M0)
  • Karnofsky performance score above 70
  • Adequate blood counts: leucocytes 2000/bcL, hemoglobin 90g/L, platelets 100000/bcL
  • Normal liver function within defined limits
  • Adequate kidney function with creatinine clearance 60 ml/min
  • Age between 18 and 64 years
  • Provided informed consent after understanding study nature
Not Eligible

You will not qualify if you...

  • Keratinizing or basaloid squamous cell carcinoma types
  • Age below 18 or above 64 years
  • Treatment intended only for symptom relief (palliative)
  • Prior cancers except treated basal or squamous skin cancer and in situ cervical cancer
  • Pregnancy or breastfeeding
  • Previous radiotherapy except limited skin cancer outside treatment area
  • Prior chemotherapy or surgery on primary tumor or lymph nodes
  • Severe other diseases affecting safety or trial compliance, such as unstable heart disease, renal disease, chronic hepatitis, or poorly controlled diabetes

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Run-in Period

Duration - Approximately 6 weeks

Participants receive docetaxel and either carboplatin or cisplatin chemotherapy every three weeks for two cycles before starting radiotherapy.

2 chemotherapy visits every three weeks

Treatment

Duration - Approximately 9 weeks

Participants receive radical radiotherapy combined with carboplatin or cisplatin chemotherapy every three weeks for three cycles during radiotherapy.

3 chemotherapy and radiotherapy visits every three weeks

Trial Site Locations

Total: 1 location

1

Southern medical university

Guangzhou, Guangdong, China, 510515

Actively Recruiting

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Research Team

J

Jian Guan, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A meta-analysis of weekly cisplatin versus three weekly cisplatin chemotherapy plus concurrent radiotherapy (CRT) for advanced head and neck cancer (HNC).

Jian Guan, Yue Zhang, Qinyang Li...

https://pubmed.ncbi.nlm.nih.gov/27602493

Interaction between tobacco and alcohol use and the risk of head and neck cancer: pooled analysis in the International Head and Neck Cancer Epidemiology Consortium.

Mia Hashibe, Paul Brennan, Shu-Chun Chuang...

https://pubmed.ncbi.nlm.nih.gov/19190158

Long-term results of a multimodal intensification regimen for previously untreated advanced resectable squamous cell cancer of the oral cavity, oropharynx, or hypopharynx.

Enver Ozer, John C Grecula, Amit Agrawal...

https://pubmed.ncbi.nlm.nih.gov/16585867

Long-term results of conventional radiotherapy versus accelerated hyperfractionated radiotherapy versus concomitant radiotherapy and chemotherapy in locoregionally advanced carcinoma of the oropharynx.

Carlo Fallai, Andrea Bolner, Marco Signor...

https://pubmed.ncbi.nlm.nih.gov/16683383

Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site.

Pierre Blanchard, Bertrand Baujat, Victoria Holostenco...

https://pubmed.ncbi.nlm.nih.gov/21684027