A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Jul 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called metronomic capecitabine to see if it can help patients with locoregionally advanced hypopharyngeal carcinoma (a type of throat cancer). The goal is to determine if this treatment can improve the time patients remain free from the disease after completing their standard therapy, which usually includes radiation and chemotherapy or surgery followed by more treatment. The trial is currently recruiting participants.

To be eligible for this trial, participants must be between 18 and 65 years old and have been diagnosed with stage IV hypopharyngeal carcinoma. They should have completed their main treatment and have no signs of the cancer returning. Participants will need to provide consent and meet certain health criteria to ensure their safety during the study. Those who join the trial can expect to receive metronomic capecitabine as an additional treatment and will be monitored closely throughout the study to assess its effects.

Gender

ALL

Eligibility 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.