Exploring Metronomic Capecitabine for Advanced Hypopharyngeal Cancer
A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma
This study is testing if a new way of giving capecitabine can help people with advanced hypopharyngeal cancer stay cancer-free after their initial treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05940441 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the effectiveness of metronomic capecitabine as an adjuvant therapy in improving disease-free survival for patients with locoregionally advanced hypopharyngeal carcinoma. Participants will have completed standard treatments such as chemoradiotherapy or surgery and will be evaluated for their eligibility based on specific clinical criteria. The treatment involves administering capecitabine in a metronomic dosing schedule to assess its impact on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with histologically confirmed stage IV hypopharyngeal carcinoma who have completed standard treatment and show no evidence of disease.
Not a fit: Patients with persistent locoregional disease or distant metastases, or those outside the specified age range, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance disease-free survival rates for patients with advanced hypopharyngeal carcinoma.
How similar studies have performed: While the specific approach of metronomic capecitabine in this context is exploratory, similar studies have shown promise in using metronomic therapies for various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Age between 18 and 65 years old. 2. Histologically confirmed hypopharyngeal carcinoma, staged as IV (T4N0-1M0，anyTN2-3M0) (as defined by the 8th AJCC edition), Complete the recommended standard treatment (curative chemoradiotherapy, or radical surgery + postoperative chemo/radiotherapy ). 3\. No clinical evidence of persistent locoregional disease or distant metastases after definitive chemoradiotherapy. 4\. Within 8 weeks after completion of the last radiation dose. 5. Performance status of ECOG grade 0 or 1. 6. 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). 7\. Patients must be appraised of the investigational nature of the study and provide written informed consent. Exclusion Criteria: * 1.Patients who were known to be intolerable or allergic to capecitabine. 2. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 3\. 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). 4\. With esophagus cancer. 5. Pregnancy or lactation. 6. Other conditions that are not eligible for enrollment.
Where this trial is running
Shanghai
- Eye & ENT Hospital, Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Lei Tao
- Email: doctortaolei@163.com
- Phone: +86-13916944810
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.