Trial Title:
Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.
NCT ID:
NCT06529562
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Conditions: Keywords:
Surgery
Target-Reduction Chemoradiotherapy
Dose-Reduction Chemoradiotherapy
Locally Resectable Nasopharyngeal Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Surgery combined with Target-reduction intensity-modulated radiotherapy
Description:
in control arm
Arm group label:
surgery plus target reduction Chemoradiotherapy
Other name:
Target-reduction intensity-modulated radiotherapy
Intervention type:
Radiation
Intervention name:
Surgery combined with Dose-reduction intensity-modulated radiotherapy
Description:
in experimental arm
Arm group label:
surgery plus dose reduction Chemoradiotherapy
Other name:
Dose-reduction intensity-modulated radiotherapy
Summary:
The goal of this clinical trial is to compare surgery plus reduced target
chemoradiotherapy with surgery plus reduced dose chemoradiotherapy in newly diagnosed
operable Nasopharyngeal Carcinoma.The main questions it aims to answer are:whether
endoscopic surgery combined with reduced dose chemoradiotherapy vs surgery plus target
reduction chemoradiotherapy can bring substantial survival benefits, lower toxicity, and
shorter treatment cycle for patients with operable nasopharyngeal carcinoma .
Detailed description:
Currently, the treatment of newly diagnosed non-metastatic nasopharyngeal carcinoma with
intensity modulated radiotherapy as the core and chemotherapy with platinum-containing
drugs has achieved good therapeutic outcomes. However, the toxicity and side effects
caused by local radiotherapy greatly affect the quality of life of patients with
nasopharyngeal carcinoma during treatment. In order to find a more "high-efficiency and
low-toxicity" nasopharyngeal cancer treatment mode, combined with minimally invasive
surgery for radical tumor treatment and radiotherapy and chemotherapy to eliminate
potential micro-metastatic lesions,, Our team has previously carried out "prospective
clinical trial of newly diagnosed operable nasopharyngeal carcinoma surgery combined with
reduced target chemoradiotherapy versus conventional chemoradiotherapy", It has been
prelim natively confirmed that gross tumor volume(GTV) and clinical tumor volume (CTV1)
high-risk infiltrating area need not be recharacterized after the combined nasopharyngeal
or non-combined retropharyngeal surgery and radical resection of cervical lesions. Only
low risk infiltrating area (CTV2) was delineated and preventive irradiation of 54 Gy/33
times /45 days was administered, combined with induction or concurrent chemotherapy.
Preliminary study results showed that it could further reduce the local recurrence of
tumors and the overall curative effect while reducing the toxic side effects of treatment
and achieve the therapeutic effect of increased efficacy and reduced toxicity.
Although compared to the conventional radiotherapy dose of 70Gy, postoperative reduced
target radiotherapy has achieved a significant reduction in radiotherapy dose while
ensuring tumor control, However, we are concerned that nearly 40% of patients still have
≥ grade 3 dry mouth, mucosal ulcer, mouth difficulty and dysphagia during or after
treatment. Therefore, for newly diagnosed patients with surgically resectable
nasopharyngeal carcinoma, we plan to conduct a prospective clinical trial comparing the
survival prognosis and toxic side effects of newly diagnosed surgery combined with
reduced dose radiotherapy compared with conventional reduced target radiotherapy combined
with concurrent chemotherapy. To explore whether this treatment model can bring
comparable survival benefits, lower toxic side effects and shorter treatment cycles for
patients.
According to our team's previous research results and literature data, we designed the
following scheme: patients with operable nasopharyngeal carcinoma were assigned to the
control group and the experimental group. Control group: nasopharyngeal combined with or
without combined retropharyngeal and neck lesions radical surgery, postoperative routine
target reduction chemoradiotherapy at the same period. Experimental group: Patients
underwent radical surgery with or without nasopharynx combined with retropharyngeal and
cervical lesions, followed by concurrent low-dose radiotherapy and chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Performance Status Score 0-1 points.
- Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated,
i.e., WHO type II or III) confirmed histologically and/or cytologically.
- Patients with primary nasopharyngeal lesions evaluated as surgically resectable,
including T1 (tumor limited to nasopharynx), T2 (tumor limited to the surface of
parapharyngeal space) and T3 (tumor limited to the bottom wall of sphenoid sinus)
and tumor diameter ≤1.5cm. Resectable retropharyngeal lymph nodes were defined as;
The diameter was ≤ 1.5cm, the tissue space was intact, and there was no obvious
extranodal invasion; The resectable cervical lymph nodes were defined as ≤ 3cm in
diameter, located above the lower edge of the cricoid cartilage, with moderate
mobility and no obvious extranodal invasion. Clinical stage: T1-3N1-2M0, T2-3N0M0
(Stage II-III) according to AJCC 8th staging edition.
- Adequate organ function: WBC ≥ 4×10^9 /L, NEUT ≥ 2×10^6 /L, HGB ≥ 9 g/dL, PLT count
≥ 100×10^9/L, TBIL ≤1.5 ULN (TBIL ≤3 ULN for patients with Gilbert Disease), ALT ≤3
ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr
≥ 60 mL/min.
- Informed Concent signed with willingness to obey the follow-up, treatment,
examination and any other programs according to the research protocol.
Exclusion Criteria:
- Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together
with any other malignancy.
- Suffering severe organ dysfunction or physical disorder which could not tolerate
surgery or radiotherapy or chemotherapy.
- Retropharyngeal lymph node diameter>1.5cm, or extranodal invasion, such as invasion
of internal carotid artery, muscle, or extensive extracapsular dissemination.
- Cervical lymph node diameter>3cm, or in the area below the lower margin of the
cricoid cartilage, or with extranodal invasion, such as invasion of the internal
carotid artery, skin, muscle, mediastinal structure, prevertebral fascia or cervical
spine, or extensive extra-capsular spread, subcutaneous metastasis, etc.
- Unable to cooperate with regular follow-up due to psychological, social, domestic or
geological reasons.
- During pregnancy or lactation.
- Other patients that the chief physician considered as illegal for this trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fifth Affiliated Hospital of Sun Yat-sen University
Address:
City:
Zhuhai
Zip:
519000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming-Yuan Chen
Phone:
+8613903052650
Email:
chmingy@email.sysu.edu.cn
Start date:
November 1, 2022
Completion date:
November 1, 2032
Lead sponsor:
Agency:
Ming-Yuan Chen
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Huazhong University of Science and Technology Union Hospital (Nanshan Hospital)
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of University of South China
Agency class:
Other
Collaborator:
Agency:
Guangxi Zhuang Autonomous Region People's Hospital
Agency class:
Other
Collaborator:
Agency:
Nanchang City First Hospital
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06529562
