IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorQiaojuan Guo
About this trial
This observational study aims to evaluate the efficacy and safety of intensity-modulated radiotherapy (IMRT) alone in patients with stage IB nasopharyngeal carcinoma (NPC) without high-risk features. The primary objective is to determine the therapeutic effectiveness of this approach
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Age > 70 years or < 18 years
Matted lymph nodes: two or more contiguous nodes with loss of intervening fat planes and/or extracapsular extension forming a confluent mass
Largest metastatic lymph-node ≥ 3 cm in the longest dimension
Lower-neck nodal metastasis: inferior border of any positive node below the inferior border of the hyoid bone
Trial population
Stage IB NPC
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
IMRT along
RadiationAll patients administered with definitive radiotherapy
Treatment groups
169 Participants
are divided into 1 treatment groupGroup A: IMRT along1 intervention
Trial outcomes
Primary outcomes
1
Relapse-Free Survival
Time from diagnosis to the disease relapse (either locoregional recurrence or distant metastasis) or death from any cause.
Time frame
3-yearSecondary outcomes
1
Locoregional Relapse-Free Survival
Time from diagnosis to first documented locoregional recurrence before the last follow-up visit.
Time frame
3-year2
Distant Metastasis-Free Survival
Time from diagnosis to first documented distant metastasis before the last follow-up visit
Time frame
3-year3
Overall Survival
Time from diagnosis to death from any cause or to the last follow-up visit for patients still alive.
Time frame
3-year4
Safety of Radiation
Acute and late radiation toxicities were graded with the CTCAE criteria
Time frame
at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Qiaojuan Guo
Lead sponsor
Fujian Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov