Comparing two chemotherapy regimens for nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the efficacy and safety of two different induction chemotherapy regimens for patients with locoregionally advanced nasopharyngeal carcinoma (NPC). The study evaluates the polymeric micellar paclitaxel-based regimen (TPC) against the standard gemcitabine and cisplatin (GP) regimen. By focusing on the pharmacological advantages of polymeric micellar paclitaxel, the trial seeks to determine whether TPC can provide better therapeutic outcomes with fewer side effects. Participants will be closely monitored for their response to treatment and any adverse effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 18 and 65 years;
2. Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma (WHO type II or III);
3. Staged as T4N0-3M0 or T1-4N2-3M0 (UICC 8th edition);
4. Easte Cooperative Oncology Group performance status of 0 or 1;
5. Adequate bone marrow: leucocyte count ≥ 4×109/L, hemoglobin ≥ 90g/L and platelet count ≥ 100×109/L;
6. Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and AST or ALT ≤ 1.5 xULN;
7. Adequate renal function: creatinine clearance rate ≥ 60 ml/min or creatinine ≤ 1.5× ULN;
8. Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment;
9. Patients must be appraised of the investigational nature of the study and provide written informed consent.

Exclusion Criteria:

1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma;
2. Treatment with palliative intent;
3. Prior malignancy (except for adequately treated carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin);
4. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume);
5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
6. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period);
7. 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 control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance;
8. Prior allergic reaction to the study drug(s) involved in this protocol.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Peking university shenzhen hospital
  Shenzhen, China Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, China Recruiting
• Affiliated cancer hospital and institute of guangzhou medical university
  Guangzhou, Please Select, China Not yet recruiting
• Sun Yat-Sen Memorial Hospital
  Guangzhou, Please Select, China Not yet recruiting
• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Please Select, China Not yet recruiting

Study contacts

• Study coordinator: Hai-Qiang Mai
• Email: maihq@sysucc.org.cn
• Phone: 086-020-8734

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.