Induction chemotherapy for advanced hypopharyngeal cancer
A Randomized Phase III Comparing Sequential Therapy With Induction Chemotherapy/Chemoradiation To Cisplatinum-Based Chemoradiotherapy in Locally Advanced Hypopharyngeal Carcinoma
This study is testing if adding induction chemotherapy before standard treatment can help people with advanced hypopharyngeal cancer do better than just having the usual treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | sunitinib, chemotherapy, radiation, anlotinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04502641 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of induction chemotherapy followed by concurrent chemoradiotherapy in patients with locally advanced hypopharyngeal carcinoma. A total of 160 patients will be randomly assigned to receive either the combination of induction chemotherapy and chemoradiotherapy or chemoradiotherapy alone. The study aims to determine if the addition of induction chemotherapy improves treatment outcomes compared to standard chemoradiotherapy. Data will be meticulously collected and analyzed to assess the efficacy of the treatment approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histopathologically confirmed stage III or IVA-B hypopharyngeal squamous cell carcinoma.
Not a fit: Patients with prior anti-tumor therapies or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and quality of life for patients with advanced hypopharyngeal cancer.
How similar studies have performed: Previous studies have shown promising results with induction chemotherapy in similar cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Male or female, aged 18 to 75 years; 2. Performance status (PS) score ≤ 2 points; 3. The expected survival period is more than 3 months; 4. Patients have histopathologically confirmed hypopharyngeal squamous cell carcinoma, including the piriform fossa, postcricoid region, and posterior pharyngeal wall with stage III and IVA-B (TNM stageT1-2N1-3M0/T3-4aN0-3M0) according to the AJCC 8th edition; 5. With measurable lesions: According to the evaluation criteria for the efficacy of solid tumors (Response Evaluation Criteria In Solid Tumors 1.1), the patient has at least one measurable lesion. The measurable lesion should not have received local treatment such as radiotherapy (target lesion located in the previous radiotherapy area, if it is confirmed that significant progress has occurred , And comply with evaluation standard, can also be used as target lesions); 6. No previous anti-tumor therapy, including anti-angiogenesis therapy, such as pazopanib, sunitinib, sorafenib, regorafenib, etc.; 7. Sufficient liver function: total bilirubin ≤ upper limit of normal value (ULN); glutamic oxalacetic transaminase (AST) and glutamic-pyruvic transaminase (ALT) ≤ 2 times upper limit of normal value (ULN); alkaline phosphatase ≤ 5 times upper limit of normal value (ULN); 8. Adequate renal function: creatinine clearance rate ≥80 mL/min; 9. Adequate blood function: absolute neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9g/dL; 10. No serious heart, lung and other important organ dysfunction; 11. Women of childbearing age must have taken reliable contraceptive measures; pregnancy tests (serum or urine) are negative within 7 days before enrollment, and must be non-lactating patients; and are willing to adopt appropriate during the test and within 6 months after the last treatment Methods of contraception. For men, it is necessary to agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last dose; 12. The subjects voluntarily joined the study and signed an informed consent form with good compliance and cooperated with the follow-up. Exclusion Criteria: * 1. Have a history of other cancers in the past five years, radical or untreated prostate cancer (Gleason score ≤ 6), or complete treatment of breast ductal carcinoma in situ, except for patients with cured skin basal cell carcinoma or squamous cell skin cancer; 2. Patients with target lesions who have received radiation therapy or surgery (except biopsy); 3. Treatment with palliative intent; 4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes; 5. Any severe coexisting disease.
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yong Chen — First Affiliated Hospital, Sun Yat-Sen University
- Study coordinator: Yong Chen
- Email: chenyong@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.