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

ConditionNon-metastatic Nasopharyngeal Carcinoma
Trial statusNot yet recruiting
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 at investigating the impact of individualized primary clinical target volume based on margin expansion on patients' prognosis and complications compared with the consensus primary clinical target volume based on margin expansion and stepwise extension pattern for patients with 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: Induction Chemoimmunotherapy (GP Regimen + PD-1 Monoclonal Antibody) + Concurrent Chemoradiotherapy (Cisplatin) + Adjuvant Immunotherapy (PD-1 Monoclonal Antibody).

  • IMRT with Individualized 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: Individualized 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 failure-free survival (LFFS)

Local failure-free survival is measured from the date of diagnosis until local recurrence.

Time frame
3 years

Secondary outcomes

1

Overall survival (OS)

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

Time frame
3 years
2

Failure-free survival (FFS)

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

Time frame
3 years
3

Distant failure-free survival (DFFS)

Distant failure-free survival is measured from the date of diagnosis until distant failure.

Time frame
3 years
4

Locoregional failure-free survival (LRFFS)

Locoregional failure-free survival is measured from the date of diagnosis until local or regional recurrence.

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

This trial is not recruiting at the moment. You can still explore other options: