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A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC

Primary Purpose

Head and Neck Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Capecitabine
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Head and Neck Neoplasms;Capecitabine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the treatment arm

the control arm

Arm Description

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

clinical observation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 18, 2018
Last Updated
September 18, 2018
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03678649
Brief Title
A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2018 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Head and Neck Neoplasms;Capecitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the treatment arm
Arm Type
Experimental
Arm Description
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
Arm Title
the control arm
Arm Type
No Intervention
Arm Description
clinical observation
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
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 .
Primary Outcome Measure Information:
Title
PFS (progression free survival)
Description
PFS is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is calculated from the date of randomization to death from any cause.
Time Frame
3-year
Title
Locoregional failure-free survival
Description
Locoregional failure-free survival is calculated from the date of randomization to the first locoregional failure.
Time Frame
3-year
Title
Distant failure-free survival
Description
Distant failure-free survival is calculated from the date of randomization to the first remote failure.
Time Frame
3-year
Title
QoL(quality of life)
Description
Changes in quality of life were assessed by EORTC C30; QLQ-H&N35 (V1.0)
Time Frame
3-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaozhong Chen, MD
Phone
+86-571-88128202
Email
cxzfyun@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD
Phone
86-571-88122098
Email
cxzfyun@sina.com
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC

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