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

NCT ID: NCT05940441

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2027-07-01

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Capecitabine 500Mg Oral Tablet

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eye & ENT Hospital, Fudan University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Tao

Role: CONTACT

+86-13916944810

Facility Contacts

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Lei Tao

Role: primary

+86-13916944810

Other Identifiers

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2023060

Identifier Type: -

Identifier Source: org_study_id

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