A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Head and Neck Neoplasms

Treatments: Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03678649

ZJCH-2018-HNC01

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

the treatment arm

Experimental group

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

Treatment:

Drug: Capecitabine

the control arm

No Intervention group

Description:

clinical observation