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
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Drug: Capecitabine||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
Metronomic capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year
- 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.
- 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). The score is between 0-100, and the higher score means worse quality of life.
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
|Contact: Ying Sun, M.D.||+86-(020)-firstname.lastname@example.org|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Ying Sun, M.D. +86-(020)-87343816 email@example.com|
|Principal Investigator:||Ying Sun, M.D.||Sun Yat-sen University|