Comparing two versus three cycles of chemotherapy for advanced nasopharyngeal cancer
Two Cycles VS Three Cycles Induction Chemotherapy Plus Concurrent Chemoradiotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma
PHASE3 · First Affiliated Hospital, Sun Yat-Sen University · NCT05860868
This study is testing whether two cycles of chemotherapy before radiation is just as effective as three cycles for people with advanced nasopharyngeal cancer.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 474 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Other (Non U.s.)) |
| Trial ID | NCT05860868 on ClinicalTrials.gov |
What this trial studies
This multi-center phase III clinical trial aims to determine if two cycles of induction chemotherapy combined with concurrent chemoradiotherapy is as effective as three cycles in treating patients with locally advanced nasopharyngeal carcinoma. The study will enroll patients aged 18-65 with pathologically confirmed non-keratinizing nasopharyngeal carcinoma, specifically those at stage T3-4N0-1 without distant metastasis. Participants will be randomly assigned to receive either two or three cycles of chemotherapy before concurrent treatment. The goal is to assess the efficacy and safety of the shorter treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with confirmed non-keratinizing nasopharyngeal carcinoma at stage T3-4N0-1.
Not a fit: Patients seeking palliative treatment or those with other concurrent malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a less intensive chemotherapy regimen that maintains effectiveness while reducing treatment burden for patients.
How similar studies have performed: Previous studies have explored induction chemotherapy in nasopharyngeal carcinoma, but this specific comparison of two versus three cycles is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-65 years old; 2. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; 3. Stage T3-4N0-1 (according to the UICC/AJCC 8th); 4. No distant metastasis; 5. Have not received anti-cancer treatment in the past; 6. ECOG (Eastern Cooperative Oncology Group of the United States): 0-1; 7. Adequate hematologic, hepatic and renal function. Exclusion Criteria: 1. The purpose of treatment is palliative; 2. Diagnosed with other malignant tumors at the same time; 3. Malignant tumor history; 4. Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period; 5. Combined serious illness.
Where this trial is running
Guangzhou, Other (Non U.s.)
- First Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Other (Non U.s.), China (RECRUITING)
Study contacts
- Study coordinator: Cheng-Tao Wang
- Email: wangcht5@mail.sysu.edu.cn
- Phone: +862087755766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced Nasopharyngeal Carcinoma