TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma

NCT06301165 | Recruiting Phase 2 DMC

• 1 other identifier: 2023-FXY-129
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Polymeric micellar paclitaxel; TPC; GP

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.

  2 years

Secondary Outcomes (5)

• Overall survival

  2 years

• Distant progression

  2 years

• Locoregional progression

  2 years

• Short-term response rate

  32 weeks

• Incidence of acute and late toxicity

  2 years

Study Arms (2)

TPC induction chemotherapy + CCRT

EXPERIMENTAL

TPC induction chemotherapy regimen followed by concurrent chemoraditherapy (cisplatin 100 mg/m2, every 3 weeks for 3 cycles) and IMRT (PTVnx 70Gy/33f; PTVnd 70Gy/33f; PTV1 60Gy/33f; PTV2 54Gy/33f)

Drug: TPC induction chemotherapy

GP induction chemotherapy + CCRT

ACTIVE COMPARATOR

GP induction chemotherapy regimen followed by concurrent chemoraditherapy (cisplatin 100 mg/m2, every 3 weeks for 3 cycles) and IMRT (PTVnx 70Gy/33f; PTVnd 70Gy/33f; PTV1 60Gy/33f; PTV2 54Gy/33f)

Drug: GP induction chemotherapy

Interventions

TPC induction chemotherapy DRUG

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).

TPC induction chemotherapy + CCRT

GP induction chemotherapy DRUG

GP induction chemotherapy regimen (gemcitabine 1000 mg/m2 D1/8, cisplatin 80 mg/m2 D1, every 3 weeks for 3 cycles)

GP induction chemotherapy + CCRT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years;
• Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma (WHO type II or III);
• Staged as T4N0-3M0 or T1-4N2-3M0 (UICC 8th edition);
• Easte Cooperative Oncology Group performance status of 0 or 1;
• Adequate bone marrow: leucocyte count ≥ 4×109/L, hemoglobin ≥ 90g/L and platelet count ≥ 100×109/L;
• Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and AST or ALT ≤ 1.5 xULN;
• Adequate renal function: creatinine clearance rate ≥ 60 ml/min or creatinine ≤ 1.5× ULN;
• 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;
• Patients must be appraised of the investigational nature of the study and provide written informed consent.

You may not qualify if:

• WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma;
• Treatment with palliative intent;
• Prior malignancy (except for adequately treated carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin);
• History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume);
• Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
• Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period);
• 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;
• Prior allergic reaction to the study drug(s) involved in this protocol.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (8)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Affiliated cancer hospital and institute of guangzhou medical university

Guangzhou, Please Select, 510060, China

NOT YET RECRUITING

Sun Yat-Sen Memorial Hospital

Guangzhou, Please Select, 510060, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Please Select, 510060, 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

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Hai-Qiang Mai

CONTACT

086-020-8734; maihq@sysucc.org.cn

Mai

CONTACT

086-020-8734; maihq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 8, 2024
• Study Start: March 19, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)