Gemcitabine
Drugfor induction chemotherapy
NCT Number: NCT05352321
Through a prospective clinical trial, we intend to combine surgery, induction chemotherapy, target-reduction intensity-modulated radiotherapy and concurrent chemotherapy as an experimental treatment for patients with newly diagnosed resectable nasopharyngeal carcinoma to illuminate whether combined surgery could bring patients better local-regional control and lower adverse reactions.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
for induction chemotherapy
for induction and concurrent chemotherapy
in active comparator arm
in experimental arm
Other names: Endoscopic nasopharyngectomy, Retropharyngeal lymphadenectomy, Neck lymph node dissection
in experimental arm
Time frame: 3 years
The LRRFS is evaluated and calculated from the date of random assignment until the day of first local regional relapse or until the date of the last follow-up visit.
Time frame: 3 years
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Time frame: 3 years
Progress-free survival is calculated from the date of randomization to the date of the first progression of any site or death or censored at the date of the last follow-up.
Time frame: 3 years
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
Time frame: 3 years
The RRFS was defined as the duration from the date of random assignment to the date of regional relapse or censored at the date of the last follow-up.
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before treatment, during treatment, after treatment.
Time frame: 1 years
The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Time frame: 3 years
The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Contact information is provided by the study sponsor or research team.
Ming-yuan Chen, MD, PhD
CONTACT
Rui You, MD, PhD
CONTACT
Sun Yat-sen University
Other
Multicenter Randomized Controlled Trial of Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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