Trial Title:
TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma
NCT ID:
NCT06301165
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Conditions: Keywords:
Polymeric micellar paclitaxel
TPC
GP
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TPC induction chemotherapy
Description:
TPC induction chemotherapy regimen contains Polymeric micellar paclitaxel, which is a
novel Cremophor EL-free, nanoparticle micellar formulation of paclitaxel, cisplatin and
capecitabine. TPC induction chemotherapy regimen (polymeric micellar paclitaxel 200 mg/m2
D1, cisplatin 75 mg/m2 D1, capecitabine 1000 mg/m2/day D1-14, every 3 weeks for 3
cycles).
Arm group label:
TPC induction chemotherapy + CCRT
Intervention type:
Drug
Intervention name:
GP induction chemotherapy
Description:
GP induction chemotherapy regimen (gemcitabine 1000 mg/m2 D1/8, cisplatin 80 mg/m2 D1,
every 3 weeks for 3 cycles)
Arm group label:
GP induction chemotherapy + CCRT
Summary:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Hai-Qiang Mai
Phone:
860-020-8734
Phone ext:
86-20-8734-364
Email:
maihq@sysucc.org.cn
Investigator:
Last name:
Hai-Qiang Mai, MD,PhD
Email:
Principal Investigator
Facility:
Name:
Affiliated cancer hospital and institute of guangzhou medical university
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Weijun Zhang
Facility:
Name:
Sun Yat-Sen Memorial Hospital
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shoumin Bai
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jiancong Sun
Facility:
Name:
Dongguan people's hospital
Address:
City:
Dongguan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhigang Liu
Facility:
Name:
Foshan First People's Hospital
Address:
City:
Foshan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ning Zhang
Facility:
Name:
Peking university shenzhen hospital
Address:
City:
Shenzhen
Country:
China
Status:
Recruiting
Contact:
Last name:
Yajie Liu, MD
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Kunyu Yang
Start date:
March 19, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06301165