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Trial Title:
A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma
NCT ID:
NCT05940441
Condition:
to Explore Whether the Adjuvant Therapy of Metronomic Capecitabine Could Improve the Disease-free Survival of Locoregionally Advanced Hypopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Capecitabine
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Capecitabine 500Mg Oral Tablet
Description:
650 mg/m² body surface area twice daily for 1 year
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).
Criteria for eligibility:
Study pop:
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 )
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Eye & ENT Hospital, Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Tao
Phone:
+86-13916944810
Email:
doctortaolei@163.com
Start date:
July 1, 2023
Completion date:
July 1, 2027
Lead sponsor:
Agency:
Eye & ENT Hospital of Fudan University
Agency class:
Other
Source:
Eye & ENT Hospital of Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05940441
