Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529562
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Surgery Plus Reduced Target Chemoradiotherapy Versus Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma a Prospective Multicenter Radomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CarcinomaThe main questions it aims to answer arewhether 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 volumeGTV 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 Gy33 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 teams 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
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 teams 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None