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Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.

ConditionNasopharyngeal Cancinoma (NPC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

To evaluate the locoregional control, survival rate, toxicity, and quality of life in patients with nasopharyngeal carcinoma treated with reduced prophylactic irradiation doses to the Low-Risk Clinical Target Volume (CTV).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiation Therapy

    Radiation

    PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：42Gy/26Fr.

  • Radiation Therapy

    Radiation

    PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：54Gy/33Fr.

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: Reduced-dose Radiotherapy for Low-risk CTVExperimental treatment 1 intervention
Group B: Standard-dose Radiotherapy for Low-risk CTVActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Locoregional relapse-free survival

Defined as the time from randomization to either documented local and/or regional relapse or death from any cause (except for metastasis), whichever occurred first.

Time frame
3 year

Secondary outcomes

1

Overall survival

Defined as the time from randomization to death from any cause.

Time frame
3 year
2

Failure-free survival

Defined as the time from randomisation to disease recurrence (distant metastasis or locoregional recurrence) or death due to any cause, whichever occurred first.

Time frame
3 year
3

Distant metastasis-free survival

Defined as the time from randomization to documented distant metastasis or death from any cause (except for locoregional relapse).

Time frame
3 year
4

Acute toxicities

Occur within 3 months after RT. Acute radiation-related toxicities are assessed using the National Cancer Institute Common Toxicity Criteria version 5.0 scale.

Time frame
3 months

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Collaborator

Affiliated Hospital of Guangdong Medical University

Collaborator

The University of Hong Kong-Shenzhen Hospital

Collaborator

Dongguan People's Hospital

Collaborator

Affiliated Cancer Hospital of Shantou University Medical College

Collaborator

Source ClinicalTrials.gov
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