Using capecitabine to improve treatment for advanced head and neck cancer
Single-agent Capecitabine as Metronomic Chemotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (CMHN)：A Phase III, Multicentre, Randomised Controlled Trial
This study is testing if adding a pill called capecitabine to the usual treatments can help people with advanced head and neck cancer live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05044117 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of metronomic capecitabine as an additional treatment for patients with locoregionally advanced head and neck squamous cell carcinoma (LAHNSCC) who have already undergone standard treatments such as surgery and radiotherapy. The aim is to determine if this oral chemotherapy can enhance patient outcomes and survival rates. Previous studies have indicated that metronomic capecitabine may improve prognosis in similar cancer types, but this is the first randomized trial to explore its use specifically in LAHNSCC. Participants will be monitored for both efficacy and safety throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults with newly diagnosed, histologically confirmed LAHNSCC who have completed standard treatment and have no evidence of disease progression.
Not a fit: Patients with distant metastases or those who have not undergone the required standard treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with advanced head and neck cancer.
How similar studies have performed: While previous studies have shown promise with metronomic capecitabine in other cancer types, this specific application in LAHNSCC is novel and has not been tested in randomized trials before.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Performance status of ECOG grade 0 or 1. 2. Tumor staged as III-IV (as defined by the 8th AJCC edition), with newly histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, larynx or hypopharynx. 3. Complete one of the following treatments: 1. Radical surgery plus radiotherapy or concurrent chemoradiotherapy 2. Neoadjuvant therapy plus radical radiotherapy or concurrent chemoradiotherapy 3. Concurrent chemoradiotherapy 4. Postoperative radiotherapy started within 4 to 8 weeks after completion of radical surgery. 5. Within 4 to 8 weeks after completion of the last radiation dose. 6. No clinical evidence of persistent locoregional disease or distant metastases before enrollment. 7. Adequate hematologic (neutrophil count \> 1.5×10\^9/L, hemoglobin \> 90g/L and platelet count \> 100×10\^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase ≤ 2.5×ULN) and renal function (creatinine clearance ≥ 50 ml/min). 8. Patients must be appraised of the investigational nature of the study and provide written informed consent. Exclusion Criteria: 1. p16 positive. 2. Patients who were known to be intolerable or allergic to capecitabine. 3. Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus. 4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 5. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). 6. Prior surgery, chemotherapy, radiotherapy or other anti-tumor treatments (except diagnostic) to primary tumor or nodes before the standard therapy. 7. Patients who received surgery treatment, biotherapy or immunotherapy during radiotherapy. 8. Patients who are receiving or highly likely to receive other chemotherapy treatment, biotherapy or immunotherapy after radiotherapy. 9. 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Ying Sun, M.D. — Sun Yat-sen University
- Study coordinator: Ying Sun, M.D.
- Email: sunying@sysucc.org.cn
- Phone: +86-(020)-87343816
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.