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

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ClinicalTrials.gov Identifier: NCT05044117
Recruitment Status : Recruiting
First Posted : September 14, 2021
Last Update Posted : March 3, 2022
Sponsor:
Collaborators:
Fujian Medical University Union Hospital
Guangzhou Panyu Central Hospital
The Central Hospital of Yongzhou
The First People's Hospital of Huaihua
Hanzhong Central Hospital
Yichang Central People's Hospital
Affiliated Hospital of Guangdong Medical University
Jiangmen Central Hospital
Xiang Yang No.1 Peoples Hospital
Information provided by (Responsible Party):
Ying Sun, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: Capecitabine Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-agent Capecitabine as Metronomic Chemotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (CMHN)：A Phase III, Multicentre, Randomised Controlled Trial
Actual Study Start Date : October 18, 2021
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Capecitabine
Metronomic capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Adverse events [ Time Frame: Up to 2 years ]
    The incidence of capecitabine-related and other adverse events.

  5. 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). The score is between 0-100, and the higher score means worse quality of life.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
    3. Concurrent chemoradiotherapy
  4. Postoperative radiotherapy started within 4 to 8 weeks after completion of radical surgery.
  5. Within 4 to 8 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 after radiotherapy.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05044117


Contacts
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Contact: Ying Sun, M.D. +86-(020)-87343816 sunying@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ying Sun, M.D.    +86-(020)-87343816    sunying@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Fujian Medical University Union Hospital
Guangzhou Panyu Central Hospital
The Central Hospital of Yongzhou
The First People's Hospital of Huaihua
Hanzhong Central Hospital
Yichang Central People's Hospital
Affiliated Hospital of Guangdong Medical University
Jiangmen Central Hospital
Xiang Yang No.1 Peoples Hospital
Investigators
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Principal Investigator: Ying Sun, M.D. Sun Yat-sen University
More Information
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Responsible Party: Ying Sun, Vice president, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT05044117    
Other Study ID Numbers: CMHN
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ying Sun, Sun Yat-sen University:
head and neck squamous cell carcinoma
locoregionally advanced disease
metronomic capecitabine
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Head and Neck Neoplasms
Neoplasms by Site
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents