Actively Recruiting
TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2024-07-08
162
Participants Needed
8
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc.
CONDITIONS
Official Title
TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Pathologically confirmed differentiated non-keratinizing carcinoma or undifferentiated non-keratinizing carcinoma (WHO type II or III)
- Staged as T4N0-3M0 or T1-4N2-3M0 according to UICC 8th edition
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate bone marrow function: leucocyte count ≥ 4×10⁹/L, hemoglobin ≥ 90 g/L, and platelet count ≥ 100×10⁹/L
- Adequate liver function: total bilirubin ≤ 1.5 times upper limit of normal and AST or ALT ≤ 1.5 times upper limit of normal
- Adequate kidney function: creatinine clearance rate ≥ 60 ml/min or creatinine ≤ 1.5 times upper limit of normal
- Women of childbearing potential and sexually active males must agree to use effective birth control during treatment
- Ability to understand the investigational nature of the study and provide written informed consent
You will not qualify if you...
- Keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma (WHO type)
- Treatment intended to be palliative only
- Previous malignancy except treated carcinoma in situ of the cervix or certain skin cancers
- Prior radiotherapy except for non-melanomatous skin cancers outside treatment area
- Previous chemotherapy or surgery (other than diagnostic) to primary tumor or lymph nodes
- Pregnancy or breastfeeding
- Serious ongoing diseases that increase risk or affect study compliance, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, or emotional disorders
- Allergic reactions to study drugs involved in this trial
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Affiliated cancer hospital and institute of guangzhou medical university
Guangzhou, Please Select, China, 510060
Not Yet Recruiting
3
Sun Yat-Sen Memorial Hospital
Guangzhou, Please Select, China, 510060
Not Yet Recruiting
4
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Please Select, China, 510060
Not Yet Recruiting
5
Dongguan people's hospital
Dongguan, China
Not Yet Recruiting
6
Foshan First People's Hospital
Foshan, China
Not Yet Recruiting
7
Peking university shenzhen hospital
Shenzhen, China
Actively Recruiting
8
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
Research Team
H
Hai-Qiang Mai
CONTACT
M
Mai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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