A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's
ConditionHead and Neck Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAll India Institute of Medical Sciences
About this trial
The present study is a phase II/III prospective randomized trial designed to determine whether eliminating of post operative radiotherapy to regional lymphatics in pN0-N1oral cavity is associated with similar treatment outcomes.
Eligibility criteria
Qualifiers
Aged 18 or above and less than 70 years
Stage pT1-4histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral/bilateral neck dissection.
Patient with high risk features: positive or close (≤ 5mm) margin, presence of LVI or PNI, pT3-4
At least one dissected hemi-neck (at least 12 nodes recovered in one dissected hemi-neck)
Disqualifiers
Non squamous histology
Presences of distant metastases
pT1-2 disease and no high risk features
Pathologically N2/N3 disease.
Trial design
Treatments tested in this trial
- IMRT - adjuvant concurrent CRT/ RT
- ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics
- Cisplatin
Treatment groups
396 Participants
are divided into 2 treatment groupsSponsors and collaborators
All India Institute of Medical Sciences
Lead sponsor
All India Institute of Medical Sciences, Rishikesh
Collaborator
All India Institute of Medical Sciences, Raipur
Collaborator
Jawaharlal Institute of Postgraduate Medical Education & Research
Collaborator
Source ClinicalTrials.gov