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

Sponsor

Eye & ENT Hospital of Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05940441

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
to Explore Whether the Adjuvant Therapy of Metronomic Capecitabine Could Improve the Disease-free Survival of Locoregionally Advanced Hypopharyngeal Carcinoma	Drug: Capecitabine 500Mg Oral Tablet

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

74 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2027

Outcome Measures

Primary Outcome Measures

disease-free survival [2023.7-2025.7]
the time from enrolled to disease recurrence (distant metastasis or locoregional recurrence) or death due to any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 ).

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 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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye & ENT Hospital, Fudan University	Shanghai		China

Sponsors and Collaborators

Eye & ENT Hospital of Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eye & ENT Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT05940441

Other Study ID Numbers:

2023060

First Posted:

Jul 11, 2023

Last Update Posted:

Jul 11, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Capecitabine

Study Results

No Results Posted as of Jul 11, 2023