Combining surgery with targeted chemoradiotherapy for nasopharyngeal cancer
Multicenter Randomized Controlled Trial of Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma
This study is testing if combining surgery with a special type of chemotherapy and targeted radiation can help people with newly diagnosed nasopharyngeal cancer do better and have fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT05352321 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of combining surgery with induction chemotherapy and target-reduction intensity-modulated radiotherapy for patients with newly diagnosed resectable nasopharyngeal carcinoma. The approach seeks to improve local-regional control of the cancer while minimizing adverse reactions compared to regular chemoradiotherapy. Patients will receive a combination of Gemcitabine, Cisplatin, and both regular and target-reduction radiotherapy as part of their treatment plan. The study will assess the outcomes of this combined treatment strategy in a prospective manner.
Who should consider this trial
Good fit: Ideal candidates include patients with newly diagnosed, histologically confirmed, resectable nasopharyngeal carcinoma who meet specific staging criteria.
Not a fit: Patients with non-resectable nasopharyngeal carcinoma or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced side effects for patients with nasopharyngeal carcinoma.
How similar studies have performed: While there have been studies on chemoradiotherapy for nasopharyngeal carcinoma, this specific combination of surgery and targeted chemoradiotherapy is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Performance Status Score 0-1 points. * Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically. * Patients with primary nasopharyngeal lesions evaluated as surgically resectable before chemotherapy, including T1 (tumor limited to nasopharynx), T2 (tumor limited to the surface of parapharyngeal space) and T3 (tumor limited to the bottom wall of sphenoid sinus or pterygoid process). Clinical stage: T1-3N1-3M0, T2-3N0M0 (Stage II-IVA) according to AJCC v8. * Patients with cervical lymph nodes evaluated as surgically resectable before chemotherapy, including cervical lymph nodes with no invasion (encasement) of the common or ICA, the epidermis, mediastinal structures, prevertebral fascia, or cervical vertebrae. * Patients with retropharyngeal lymph nodes evaluated as surgically resectable before chemotherapy, including simple RPLNs with intact capsule or RPLNs ≤ 1.5cm with mouth opening range \> 4cm. * Adequate organ function: WBC ≥ 4×10\^9 /L, NEUT ≥ 2×10\^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10\^9/L, TBIL ≤1.5 ULN (TBIL ≤3 ULN for patients with Gilbert Disease), ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min. * Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol. Exclusion Criteria: * Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy. * Suffering severe cardiopathy or pulmonary dysfunction with cardiac or pulmonary function no more than grade 3. * Extensive recurrent primary tumour beyond the resectable area such as extensive invasion of the skull base or a distance from the tumour margins to the internal carotid artery of less than 0·5 cm. * Retropharyngeal lymph node involved or adjacent to primary nasopharyngeal lesions (less than 0·5 cm). * Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons. * During pregnancy or lactation. * Other patients that the chief physician considered as illegal for this trial.
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Fifth Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Ming-yuan Chen, MD, PhD — Sun Yat-sen University
- Study coordinator: Ming-yuan Chen, MD, PhD
- Email: chmingy@mail.sysu.edu.cn
- Phone: 02087342422
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.