Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma
NCT ID: NCT06516133
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
494 participants
INTERVENTIONAL
2024-05-17
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional radiotherapy with conventional margins w or w/o chemotherapy
Complete the full course of radiotherapy using the original treatment plan. PTV margin: 3mm.
Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy
Radiation: Complete the full course of radiotherapy using the original treatment plan.
Planning target volume (PTV) margin: 3mm;
Chemotherapy
Chemotherapy: If given, platinum-based.
Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy
Throughout 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 the patients.
PTV margin: smaller.
Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy
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.
Chemotherapy
Chemotherapy: If given, platinum-based
Interventions
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Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy
Radiation: Complete the full course of radiotherapy using the original treatment plan.
Planning target volume (PTV) margin: 3mm;
Chemotherapy
Chemotherapy: If given, platinum-based.
Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy
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.
Chemotherapy
Chemotherapy: If given, platinum-based
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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YingSun
Principal Investigator
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SL-B2023-685-02
Identifier Type: -
Identifier Source: org_study_id
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