CTVp1-NPC: Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Reduction CTVp1 CTVp1=GTVp+5mm |
Radiation: Reduction CTVp1
High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)
|
| Placebo Comparator: Non-reduction CTVp1 CTVp1=GTVp+5mm+whole nasopharynx |
Radiation: Non-reduction CTVp1
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)
|
Outcome Measures
Primary Outcome Measures
- Local Relapse-free Survival(LRFS) [3 years]
the time from randomization to documented local recurrence or death from any cause
- Incidence of hearing impairment worse than graded 2 [3 years]
audiometry and symptoms graded according to the CTCAE (version 5.0).
Secondary Outcome Measures
- Overall survival (OS) [3 years]
the time from randomization to documented death from any cause
- Regional Relapse-free Survival(RRFS) [3 years]
the time from randomization to documented regional recurrence or death from any cause
- Distant metastasis-free survival (DMFS) [3 years]
calculated from randomization to documented distant metastasis or death
- Acute toxicities [3 months]
Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0
- Late toxicities [3 years]
3 months after completion of radiotherapy graded according to both the Radiation Therapy Oncology Group criteria and the CTCAE (version 5.0)
- Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35) [3 years]
Patient reported quality-of-life data and higher scores indicated more severe symptoms
- Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30) [3 years]
Patient reported quality-of-life data and higher scores indicated more severe symptoms
- radiation-induced otitis media with effusion (OME) [3 years]
Evaluated by tympanometry
- V60Gy [3 years]
Volume that received at least 60Gy
Eligibility Criteria
Criteria
Inclusion Criteria:
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histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
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newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system
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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.
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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 )
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no previous treatment for cancer；
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a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability);
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between 18 and 70 years old;
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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);
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Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
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receipt of treatment with palliative intent;
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receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx;
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had disease progress after neoadjuvant chemotherapy in local advantage NPC
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presence of distant metastasis;
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Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
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Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
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Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
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lactation or pregnancy;
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Any other condition including Mental disorder,drug or alcohol addition;do not have full capacity for civil acts.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan City People's Hospital | Zhongshan | Guangdong | China | 528403 |
Sponsors and Collaborators
- Zhongshan People's Hospital, Guangdong, China
- Sun Yat-sen University Cancer Centre
Investigators
- Principal Investigator: Gui-qiong Xu, Zhongshan People's Hospital, Guangdong, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZSCPH-002