A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC

NCT03678649 | Unknown Phase 2 DMC

• 1 other identifier: ZJCH-2018-HNC01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms

Keywords

Head and Neck Neoplasms;Capecitabine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival

  3-year

• Locoregional failure-free survival

  3-year

• Distant failure-free survival

  3-year

• QoL(quality of life)

  3-year

Study Arms (2)

the treatment arm

EXPERIMENTAL

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

Drug: Capecitabine

the control arm

NO INTERVENTION

clinical observation

Interventions

Capecitabine DRUG

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 .

the treatment arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically type： squamous cell carcinoma
• head and neck squamous cell carcinoma (HNSCC), Tumor staged as III to IVb (according to the 8th AJCC edition).
• Eastern cooperative oncology group (ECOG) performance status 0 or 1
• Age between 18 and 65 years old
• Prior treatment with chemo-radiotherapy (CRT) based Platinum drugs.
• Adequate marrow: WBC count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
• 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.
• Adequate renal function: creatinine clearance ≥60 ml/min.
• Patients must be informed of the investigational nature of this study and give written informed consent.

You may not qualify if:

• Nasopharyngeal carcinoma and/or salivary gland carcinoma.
• Any other malignancy (except for primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ)
• currently recurrent of metastatic disease
• received research drug in 4 weeks
• Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
• Severe hematological abnormality and intolerance to chemotherapy
• 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.
• Pregnancy or breast feeding
• patients who cannot obey to completion of the study

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Xiaozhong Chen, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaozhong Chen, MD

CONTACT

+86-571-88128202; cxzfyun@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: September 10, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2023
• Last Updated: September 19, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)