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

NCT05044117 | Recruiting Phase 3

• 1 other identifier: CMHN
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

head and neck squamous cell carcinoma; locoregionally advanced disease; metronomic capecitabine

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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.

  2 years

Secondary Outcomes (5)

• Overall survival

  2 years

• Distant failure-free survival

  2 years

• Locoregional failure-free survival

  2 years

• Adverse events

  Up to 2 years

• Patient reported quality-of-life score

  Up to 2 years

Study Arms (2)

Clinical observation

NO INTERVENTION

The standard treatment followed by clinical observation.

Metronomic capecitabine

EXPERIMENTAL

The standard treatment followed by a maintenance therapy with capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year.

Drug: Capecitabine

Interventions

Capecitabine DRUG

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

Metronomic capecitabine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Performance status of ECOG grade 0 or 1.
• 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.
• Complete one of the following treatments:
• Radical surgery plus radiotherapy or concurrent chemoradiotherapy
• Neoadjuvant therapy plus radical radiotherapy or concurrent chemoradiotherapy
• Concurrent chemoradiotherapy
• Postoperative radiotherapy started within 4 to 8 weeks after completion of radical surgery.
• Within 4 to 8 weeks after completion of the last radiation dose.
• No clinical evidence of persistent locoregional disease or distant metastases before enrollment.
• 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).
• Patients must be appraised of the investigational nature of the study and provide written informed consent.

You may not qualify if:

• p16 positive.
• Patients who were known to be intolerable or allergic to capecitabine.
• Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus.
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
• Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
• Prior surgery, chemotherapy, radiotherapy or other anti-tumor treatments (except diagnostic) to primary tumor or nodes before the standard therapy.
• Patients who received surgery treatment, biotherapy or immunotherapy during radiotherapy.
• Patients who are receiving or highly likely to receive other chemotherapy treatment, biotherapy or immunotherapy after radiotherapy.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Fujian Medical University Union Hospital: collaborator
• Guangzhou Panyu Central Hospital: collaborator
• The Central Hospital of Yongzhou: collaborator
• The First People's Hospital of Huaihua: collaborator
• Hanzhong Central Hospital: collaborator
• Yichang Central People's Hospital: collaborator
• Affiliated Hospital of Guangdong Medical University: collaborator
• Jiangmen Central Hospital: collaborator
• Xiang Yang No.1 Peoples Hospital: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

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

• Ying Sun, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Sun, M.D.

CONTACT

+86-(020)-87343816; sunying@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 14, 2021
• Study Start: October 18, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)