RecruitingNCT05940441

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

Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

74 participants

Start Date

Jul 1, 2023

Study Type

OBSERVATIONAL

Conditions

to Explore Whether the Adjuvant Therapy of Metronomic Capecitabine Could Improve the Disease-free Survival of Locoregionally Advanced Hypopharyngeal Carcinoma

Summary

To explore whether the adjuvant therapy of metronomic capecitabine could improve the disease-free survival of locoregionally advanced hypopharyngeal carcinoma (stage IV：T4N0-1M0，anyTN2-3M0).

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

\. 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 ).
\. No clinical evidence of persistent locoregional disease or distant metastases after definitive chemoradiotherapy.
\. 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).
\. Patients must be appraised of the investigational nature of the study and provide written informed consent.

Exclusion Criteria3

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.
\. 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).
\. With esophagus cancer. 5. Pregnancy or lactation. 6. Other conditions that are not eligible for enrollment.

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Interventions

DRUGCapecitabine 500Mg Oral Tablet

650 mg/m² body surface area twice daily for 1 year

Locations(1)

Eye & ENT Hospital, Fudan University

Shanghai, China

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NCT05940441