Single-agent Capecitabine as Metronomic Chemotherapy in LAHNSCC (CMHN)

Overview

The purpose of this study is to investigate whether the addition of metronomic capecitabine to the standard treatment can improve prognosis in locoregionally advanced head and neck squamous cell carcinoma.

Full Title of Study: “Single-agent Capecitabine as Metronomic Chemotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (CMHN):A Phase III, Multicentre, Randomised Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2026

Detailed Description

The standard treatment for resectable locoregionally advanced squamous cell carcinoma of the head and the neck (LAHNSCC) is a regimen consisting of radical surgery plus radiotherapy or concurrent chemoradiotherapy. And induction chemotherapy plus radical radiotherapy or concurrent chemoradiotherapy is also recommended for locoregionally advanced squamous cell carcinoma of larynx and hypopharynx. With the extensive application of comprehensive treatment, the 5-year overall survival of LAHNSCC has not reached 50% yet. So, it is urgent to explore a regimen with high efficiency and low toxicity on the basis of existing standard treatment. Two retrospective studies found that the metronomic use of orally administered fluorouracil drugs following the reference treatment significantly improved prognosis in LAHNSCC. And capecitabine is one kind of the oral fluorouracil drugs, which has high efficiency and low toxicity. Indeed, metronomic capecitabine maintenance was shown to be effective in patients with breast cancer, colorectal cancer, and nasopharyngeal carcinoma in phase III trials. The abovementioned studies suggested the promising use of metronomic capecitabine in LAHNSCC. However, there has been no randomized trials in this field. Therefore, we initiated a randomized phase III trial to investigate the efficacy and safety of the addition of metronomic capecitabine to the standard treatment in LAHNSCC.

Interventions

  • Drug: Capecitabine
    • Metronomic capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year

Arms, Groups and Cohorts

  • No Intervention: Clinical observation
    • The standard treatment followed by clinical observation.
  • Experimental: Metronomic capecitabine
    • The standard treatment followed by a maintenance therapy with capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year.

Clinical Trial Outcome Measures

Primary Measures

  • Progression-free survival
    • Time Frame: 2 years
    • PFS will be measured from the day of randomization until treatment failure, death from any cause, or the last follow-up visit, whichever occurred first.

Secondary Measures

  • Overall survival
    • Time Frame: 2 years
    • OS will be measured from the day of randomization until death due to any cause, or the last follow-up visit.
  • Distant failure-free survival
    • Time Frame: 2 years
    • DFFS will be measured from the day of randomization until death until distant metastasis, or the last follow-up visit.
  • Locoregional failure-free survival
    • Time Frame: 2 years
    • LRFFS will be measured from the day of randomization until death until local and/or regional recurrence, or the last follow-up visit.
  • Adverse events
    • Time Frame: Up to 2 years
    • The incidence of capecitabine-related and other adverse events.
  • Patient reported quality-of-life score
    • Time Frame: Up to 2 years
    • Patient reported quality of life would be evaluated using the Quality of Life Questionnaire-Core 30 module (QLQ-C30).

Participating in This Clinical Trial

Inclusion Criteria

1. Performance status of ECOG grade 0 or 1. 2. Tumor staged as III-IV (as defined by the 8th AJCC edition), with newly histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, larynx or hypopharynx. 3. Complete one of the following treatments: 1. Radical surgery plus radiotherapy or concurrent chemoradiotherapy 2. Neoadjuvant therapy plus radical radiotherapy or concurrent chemoradiotherapy 4. Postoperative radiotherapy started within 4 to 8 weeks after completion of radical surgery. 5. Within 4 to 6 weeks after completion of the last radiation dose. 6. No clinical evidence of persistent locoregional disease or distant metastases before enrollment. 7. Adequate hematologic (neutrophil count > 1.5×10^9/L, hemoglobin > 90g/L and platelet count > 100×10^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase ≤ 2.5×ULN) and renal function (creatinine clearance ≥ 50 ml/min). 8. Patients must be appraised of the investigational nature of the study and provide written informed consent. Exclusion Criteria:

1. p16 positive. 2. Patients who were known to be intolerable or allergic to capecitabine. 3. Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus. 4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 5. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). 6. Prior surgery, chemotherapy, radiotherapy or other anti-tumor treatments (except diagnostic) to primary tumor or nodes before the standard therapy. 7. Patients who received surgery treatment, biotherapy or immunotherapy during radiotherapy. 8. Patients who are receiving or highly likely to receive other chemotherapy treatment, biotherapy or immunotherapy. 9. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Collaborator
    • Fujian Medical University Union Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ying Sun, Vice president – Sun Yat-sen University
  • Overall Official(s)
    • Ying Sun, M.D., Principal Investigator, Sun Yat-sen University
  • Overall Contact(s)
    • Ying Sun, M.D., +86-(020)-87343816, sunying@sysucc.org.cn

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