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Trial Title:
Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma
NCT ID:
NCT05994170
Condition:
Nasopharyngeal Carcinoma
Intensity-Modulated Radiotherapy
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Radiation
Intervention name:
Reduction CTVp1
Description:
High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from
GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)
Arm group label:
Reduction CTVp1
Intervention type:
Radiation
Intervention name:
Non-reduction CTVp1
Description:
High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx
as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx)
Arm group label:
Non-reduction CTVp1
Summary:
To evaluate the long-term local control, survival rate, acute and late radiation related
toxicities, quality of life after reducing high risk primary tumor clinical target
volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.
Detailed description:
This phase 3, multicenter,randomized controlled clinical trial recruits patients with
newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The
intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as
GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local
control, survival rate, acute and late radiation related toxicities between the two
groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
2. newly diagnosed stage I to IVa according to the American Joint Committee on
Cancer-Union for International Cancer Control 8th edition stage-classification
system
3. nasopharyngeal mass confined to one side of nasopharynx and did not exceed the
midline(the line between the nasal septum and the midpoint of spinal cord/medulla)
detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI).
Pathological biopsy was recommended if it was unclear whether tumor invaded the
contralateral side radiographically.
4. planned to receive curative IMRT, Chemotherapy drugs should be administered
according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the
TNM stage;(T1N0: No chemotherapy required;T2N0：No chemotherapy or concurrent
cisplatin chemoradiotherapy if there are adverse prognostic indicators such as
Epstein-Barr virus (EBV) DNA>4000 copies，node >3cm or with extranodal
extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin
chemoradiotherapy; stage III-Iva: platinum-based neoadjuvant chemotherapy+
concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy )
5. no previous treatment for cancer；
6. a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with
lower scores indicating greater disability);
7. between 18 and 70 years old;
8. adequate hematologic, renal, and hepatic function: Adequate marrow function: WBC
count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥
100×10E9/L;Adequate liver function: ALT and AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;Adequate
renal function: BUN and CRE ≤ 1.5×ULN , endogenous creatinine clearance ≥ 60ml/min
(Cockcroft-Gault formula);
9. Patients must be informed of the investigational nature of this study and give
written informed consent.
Exclusion Criteria:
1. receipt of treatment with palliative intent;
2. receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except
diagnostic procedures]) to the nasopharynx;
3. had disease progress after neoadjuvant chemotherapy in local advantage NPC
4. presence of distant metastasis;
5. Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
6. Prior malignancy except adequately treated non-melanoma skin cancer, in situ
cervical cancer, and papillary thyroid carcinoma;
7. Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial
-infarction within 1 year, or clinically meaningful arrhythmia that requires
treatment;
8. lactation or pregnancy;
9. Any other condition including Mental disorder,drug or alcohol addition;do not have
full capacity for civil acts.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan City People's Hospital
Address:
City:
Zhongshan
Zip:
528403
Country:
China
Status:
Recruiting
Contact:
Last name:
Guiqiong Xu
Phone:
+8613528109888
Email:
donna_shee@163.com
Contact backup:
Last name:
Yu-long Xie, MD
Phone:
+8615625031643
Email:
xieyl1@sysucc.org.cn
Start date:
August 4, 2023
Completion date:
September 1, 2029
Lead sponsor:
Agency:
Zhongshan People's Hospital, Guangdong, China
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University Cancer Centre
Agency class:
Other
Source:
Zhongshan People's Hospital, Guangdong, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05994170
