A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC

NCT ID: NCT03678649

Last Updated: 2018-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2023-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the treatment arm

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

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: 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 control arm

clinical observation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 .

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen Xiaozhong

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaozhong Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaozhong Chen, MD

Role: CONTACT

cxzfyun@sina.com

+86-571-88128202

Facility Contacts

Xiaozhong Chen, MD

Role: primary

cxzfyun@sina.com

86-571-88122098

Other Identifiers

ZJCH-2018-HNC01

Identifier Type: -

Identifier Source: org_study_id