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Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma

ConditionNon-metastatic Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University

About this trial

This is a non-inferiority, multicenter, randomized phase 3 trial aimed to evaluate whether primary clinical target volume (CTVp) delineation based on margin expansion provides comparable outcomes compared with the consensus CTVp approach based on margin expansion and the stepwise extension pattern in newly diagnosed non-metastatic nasopharyngeal carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 Years to 65 Years.

Eastern Cooperative Oncology Group performance status ≤1.

Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma (non-keratinizing subtype).

Tumor staged as T1-4N0-3M0 (AJCC 9th).

Disqualifiers

Active tuberculosis: active tuberculosis within the past 1 year should be excluded regardless of treatment; a history of active tuberculosis > 1 year ago is exclusionary unless prior adequate anti-tuberculosis treatment is documented.

Active infection requiring systemic treatment.

Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer.

History of radiotherapy, except for non-melanoma skin cancer located outside the target volume of radiotherapy for nasophayngeal carcinoma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Comprehensive Therapy Based on Tumor Stage

    Procedure/Surgery

    1. T1N0: Radiotherapy Only. 2. T1N1, T2N0-1, T3N0: Radiotherapy with or without Concurrent Chemotherapy (Cisplatin). 3. T3N1, T4N0: Concurrent Chemoradiotherapy (Cisplatin) with or without Induction Chemotherapy (GP Regimen). 4. T1-4N2-3, T4N1: ① Induction Chemotherapy (GP Regimen) + Concurrent Chemoradiotherapy (Cisplatin); ② Induction Chemoimmunotherapy (GP Regimen + PD-1 Monoclonal Antibody) + Concurrent Chemoradiotherapy (Cisplatin) + Adjuvant Immunotherapy (PD-1 Monoclonal Antibody); ③ Induction Chemotherapy (GP Regimen) + Concurrent Chemoradiotherapy (Cisplatin) + Adjuvant Immunotherapy (PD-1 Monoclonal Antibody).

  • IMRT with Primary Clinical Target Volume Based on Margin Expansion

    Radiation

    1. Target delineation: 1. CTVp\_High = GTVp + 0 mm; 2. CTVp\_Mid = CTVp\_High + 5 mm; 3. CTVp\_Low = CTVp\_Mid + 5 mm + whole nasopharynx; 4. CTVn\_High = GTVn + 0 mm; 5. CTVn\_Mid = CTVn\_High + 3-5 mm (for nodes with imaging-detected extranodal extension) or 0 mm (for nodes without imaging-detected extranodal extension) + equivocal nodes in the anticipated drainage levels, close proximity to enlarged nodes, or with suspicious PET results; 6. CTVn\_Low = CTVn\_Mid + 3 mm + elective drainage levels. 2. Dose prescription: 1. 6996 cGy/33 fx for CTVp\_High and CTVn\_High; 2. 6006 cGy/33 fx for CTVp\_Mid and CTVn\_Mid; 3. 5412 cGy/33 fx for CTVp\_Low and CTVn\_Low.

  • IMRT with Consensus Primary Clinical Target Volume

    Radiation

    1. Target delineation: 1. CTVp\_High = GTVp + 0 mm; 2. CTVp\_Mid = CTVp\_High + 5 mm; 3. CTVp\_Low = CTVp\_Mid + 5 mm + whole nasopharynx + high-risk structures based on stepwise local extension patterns of tumor spread; 4. CTVn\_High = GTVn + 0 mm; 5. CTVn\_Mid = CTVn\_High + 3-5 mm (for nodes with imaging-detected extranodal extension) or 0 mm (for nodes without imaging-detected extranodal extension) + equivocal nodes in the anticipated drainage levels, close proximity to enlarged nodes, or with suspicious PET results; 6. CTVn\_Low = CTVn\_Mid + 3 mm + elective drainage levels; 2. Dose prescription: 1. 6996 cGy/33 fx for CTVp\_High and CTVn\_High; 2. 6006 cGy/33 fx for CTVp\_Mid and CTVn\_Mid; 3. 5412 cGy/33 fx for CTVp\_Low and CTVn\_Low.

Treatment groups

568 Participants
are divided into 2 treatment groups
Group A: Primary Clinical Target Volume Based on Margin ExpansionExperimental treatment 2 interventions
Group B: Consensus Primary Clinical Target Volume Based on Margin Expansion and Stepwise Extension PatternActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Local relapse-free survival (LRFS)

Local relapse-free survival is estimated from randomisation to documented local relapse or death.

Time frame
3 years

Secondary outcomes

1

Overall survival (OS)

Overall survival is measured from the date of randomisation until death from any cause.

Time frame
3 years
2

Failure-free survival (FFS)

Failure-free survival is measured from the date of randomisation until local recurrence, regional recurrence, distant failure, or death from any cause, whichever occurs first.

Time frame
3 years
3

Distant metastasis-free survival (DMFS)

Distant metastasis-free survival is calculated from randomisation to documented distant metastasis or death.

Time frame
3 years
4

Locoregional relapse-free survival (LRFFS)

Locoregional relapse-free survival is measured from the date of randomisation until local or regional recurrence or death.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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