Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma
Study Details
Study Description
Brief Summary
This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Reduced CTVn2 Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level. |
Radiation: Intensity Modulated Radiation Therapy
All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
Other Names:
Drug: Chemotherapy
Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.
|
| Active Comparator: Conventional CTVn2 Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline. |
Radiation: Intensity Modulated Radiation Therapy
All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
Other Names:
Drug: Chemotherapy
Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.
|
Outcome Measures
Primary Outcome Measures
- Regional recurrence-free survival [3 years]
From the date of randomization to regional recurrence or any death
Secondary Outcome Measures
- Overall survival [3 years]
From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up
- Local recurrence-free survival [3 years]
From the date of randomization to local recurrence or any death
- Distant metastasis-free survival [3 years]
From the date of randomization to distant metastasis or any death
- Progression free survival [3 years]
From the date of randomization to local or regional recurrence, distant metastasis or any death
- Acute toxicities [From the start of treatment until 3 months post treatment]
Assessed with CTCAE v5.0
- Late toxicities [3 years post treatment]
Assessed with RTOG/EORTC
- Quality of life score [During treatment and 3 years post treatment]
Assessed with EORTC-Quality of life questionnaire-C30 version 3.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
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All genders, range from 18-70 years old;
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ECOG score 0-1;
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Clinical stage I-IVa (AJCC/UICC 8th);
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Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
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No contraindications to chemotherapy or radiotherapy;
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Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
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Sign the consent form.
Exclusion Criteria:
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Neck lymph nodes exist skipping metastasis;
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Distant metastases;
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Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
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Have or are suffering from other malignant tumors;
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Participating in other clinical trials;
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Pregnancy or lactation;
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Have uncontrolled cardiovascular disease;
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Severe complication, eg, uncontrolled hypertension;
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Mental disorder;
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Drug or alcohol addition;
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Do not have full capacity for civil acts.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sun Yat-sen University
- Jiangxi Provincial Cancer Hospital
- Zhejiang Cancer Hospital
- Chongqing University Cancer Hospital
- Dongguan People's Hospital
- LiuZhou People's Hospital
Investigators
- Principal Investigator: Chong Zhao, MD PhD, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Reduced CTV in NPC