Comparing two chemotherapy regimens for nasopharyngeal carcinoma

TPC Versus GP Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma, a Multi-center Phase II Randomized Trial

This study is testing whether a new chemotherapy treatment for nasopharyngeal carcinoma can work better and cause fewer side effects than the standard treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy
• Locations: 8 sites (Guangzhou, Guangdong and 7 other locations)
• Trial ID: NCT06301165 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with pathologically confirmed non-keratinizing nasopharyngeal carcinoma staged as T4N0-3M0 or T1-4N2-3M0.

Not a fit: Patients with keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with nasopharyngeal carcinoma, potentially enhancing survival rates and reducing side effects.

How similar studies have performed: While there have been studies on various chemotherapy regimens for NPC, the specific use of polymeric micellar paclitaxel in this context is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong and 7 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, 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)
• Dongguan people's hospital — Dongguan, China (NOT_YET_RECRUITING)
• Foshan First People's Hospital — Foshan, China (NOT_YET_RECRUITING)
• Peking university shenzhen hospital — Shenzhen, China (RECRUITING)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (RECRUITING)

Study contacts

• Study coordinator: Hai-Qiang Mai

Conditions: Nasopharyngeal Carcinoma, Polymeric micellar paclitaxel, TPC, GP