A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC

Head and Neck Neoplasms Clinical Trial

Official title:

A Prospective Randomized Controlled Clinical Trial of Capecitabine Treatment in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck After Radiotherapy: Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03678649
• Other study ID #: ZJCH-2018-HNC01
• Status: Recruiting
• Phase: Phase 2
• Start date: September 10, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2018
• Source: Zhejiang Cancer Hospital
• Contact: Xiaozhong Chen, MD
• Phone: +86-571-88128202
• Email: cxzfyun[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Drug:
• 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 .

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS (progression free survival)	PFS is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.	3-year
Secondary	Overall survival	Overall survival is calculated from the date of randomization to death from any cause.	3-year
Secondary	Locoregional failure-free survival	Locoregional failure-free survival is calculated from the date of randomization to the first locoregional failure.	3-year
Secondary	Distant failure-free survival	Distant failure-free survival is calculated from the date of randomization to the first remote failure.	3-year
Secondary	QoL(quality of life)	Changes in quality of life were assessed by EORTC C30; QLQ-H&N35 (V1.0)	3-year