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Trial Title:
Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma
NCT ID:
NCT06516133
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Conditions: Keywords:
Nasopharyngeal Carcinoma
Online adaptive radiotherapy
Smaller PTV margin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy
Description:
Radiation: Complete the full course of radiotherapy using the original treatment plan.
Planning target volume (PTV) margin: 3mm;
Arm group label:
Conventional radiotherapy with conventional margins w or w/o chemotherapy
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Chemotherapy: If given, platinum-based.
Arm group label:
Conventional radiotherapy with conventional margins w or w/o chemotherapy
Intervention type:
Radiation
Intervention name:
Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy
Description:
Radiation: During the course of radiotherapy, the treatment plan is adjusted online based
on the anatomical and dosimetric changes in the target volumes and organs at risk of
patients.
planning target volume (PTV) margin: smaller.
Arm group label:
Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Chemotherapy: If given, platinum-based
Arm group label:
Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy
Summary:
In this multicenter, prospective, randomized, controlled, non-inferiority Phase III
clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without
metastasis will be enrolled for curative radiotherapy. The participants will be randomly
assigned to two groups. The experimental group will receive online adaptive radiotherapy
(ART) during the radiotherapy process, with a smaller PTV margin, while the control group
will use original treatment plan during full-course radiotherapy, with a PTV margin of 3
mm. The study aims to compare the survival, adverse events, and quality of survival
between the two groups, with the primary endpoint being the locoregional recurrence-free
survival rate. The main objective is to determine the role of online ART in
nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in
patients while ensuring treatment efficacy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Newly diagnosed nasopharyngeal carcinoma confirmed by pathology, with a histological
classification of non-keratinizing carcinoma (according to the World Health
Organization, WHO), pathological classification.
2. No evidence of distant metastasis (M0).
3. Age between 18 and 70 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status score:0-1.
5. Undergoing radical intensity-modulated radiation therapy (IMRT).
6. No claustrophobia and able to remain in a fixed position for at least 30 minutes
7. Patients must be informed of the main content of this study, sign an informed
consent form, and be willing and able to comply with the treatment, follow-up plan,
laboratory tests, and other requirements specified in the study protocol.
Exclusion Criteria:
1. Histological types include squamous cell carcinoma or basal cell carcinoma.
2. Radiation therapy intended for palliative care.
3. History of malignant tumors, excluding adequately treated basal cell carcinoma,
squamous cell carcinoma, and cervical intraepithelial neoplasia.
4. Pregnant or lactating women (women of childbearing age should undergo pregnancy
testing; effective contraception should be emphasized during treatment.
5. Previous radical radiotherapy for nasopharyngeal cancer.
6. Primary and neck metastatic lesions treated with chemotherapy or surgery.
7. Presence of other serious underlying diseases that may pose a greater risk or affect
compliance with the trial. Examples include unstable cardiac diseases requiring
treatment, renal diseases, chronic hepatitis, poorly controlled diabetes (fasting
blood glucose > 1.5×ULN), and psychiatric disorders.
8. Initial assessment of treatment efficacy more than 120 days after the end of
radiotherapy.
9. Inability to undergo enhanced magnetic resonance imaging due to contrast agent
allergies, claustrophobia.
Gender:
All
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu-xian Yang
Phone:
+86 147 4892 2370
Email:
yangyx1@sysucc.org.cn
Contact backup:
Last name:
Guan-quan Zhou
Phone:
+86 159 1437 2887
Email:
zhougq@sysucc.org.cn
Investigator:
Last name:
Ying Sun, PhD
Email:
Principal Investigator
Start date:
May 17, 2024
Completion date:
December 2030
Lead sponsor:
Agency:
Sun Yat-sen University
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/NCT06516133
