A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC

Phase 2

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: Capecitabine

• Registration Number: NCT03678649
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

This prospective randomized controlled clinical Trial will be performed in patients with locally advanced squamous cell carcinoma of the head and neck. The objectives of the trial are to compare the efficacy and safety of Capecitabine treatment with placebo as adjuvant therapy to patients who have received radiotherapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-10
• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-18
• Last Update Submitted: 2018-09-18
• Study First Posted: 2018-09-19
• Last Update Posted: 2018-09-19
• Primary Completion: 2020-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. histologically type： squamous cell carcinoma
2. head and neck squamous cell carcinoma (HNSCC), Tumor staged as III to IVb (according to the 8th AJCC edition).
3. Eastern cooperative oncology group (ECOG) performance status 0 or 1
4. Age between 18 and 65 years old
5. Prior treatment with chemo-radiotherapy (CRT) based Platinum drugs.
6. Adequate marrow: WBC count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
7. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.
8. Adequate renal function: creatinine clearance ≥60 ml/min.
9. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria

1. Nasopharyngeal carcinoma and/or salivary gland carcinoma.
2. Any other malignancy (except for primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ)
3. currently recurrent of metastatic disease
4. received research drug in 4 weeks
5. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
6. Severe hematological abnormality and intolerance to chemotherapy
7. Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
8. Pregnancy or breast feeding
9. patients who cannot obey to completion of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the treatment arm	Capecitabine	1000-1250 mg/m2 orally twice daily for 14 days followed by a 1-week rest period, given as 3- week cycles for a total of 6 cycles . it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measures

Name	Time	Method
PFS (progression free survival)	3-year	PFS is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

Secondary Outcome Measures

Name	Time	Method
Locoregional failure-free survival	3-year	Locoregional failure-free survival is calculated from the date of randomization to the first locoregional failure.
Distant failure-free survival	3-year	Distant failure-free survival is calculated from the date of randomization to the first remote failure.
QoL(quality of life)	3-year	Changes in quality of life were assessed by EORTC C30; QLQ-H\&N35 (V1.0)
Overall survival	3-year	Overall survival is calculated from the date of randomization to death from any cause.

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China