Recruitment

Recruitment Status
Active, not recruiting

Summary

Conditions
Squamous Cell Carcinoma of the Head and Neck
Type
Interventional
Phase
Phase 2Phase 3
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

Squamous cell carcinoma of head and neck (HNSCC) is being increasingly treated by multimodality approaches combining surgery, radiotherapy, and chemotherapy. Randomized controlled trials have demonstrated major improvements in loco-regional tumor control from altered fractionation radiotherapy with ...

Squamous cell carcinoma of head and neck (HNSCC) is being increasingly treated by multimodality approaches combining surgery, radiotherapy, and chemotherapy. Randomized controlled trials have demonstrated major improvements in loco-regional tumor control from altered fractionation radiotherapy with chemotherapy as compared with conventional fractionation. Altered fractionation schedules seek to improve the therapeutic ratio between tumor cell kill and normal tissue damage by exploiting the dissociation between acute and late radiation effects. Hypofractionated radiotherapy utilizes a small number of fractions with a larger dose per fraction, shortening overall treatment time compared to a conventional protocol . Although a shorter treatment time can be obtained by applying a higher dose per fraction, it might also result in a disproportionate increase in the incidence of late complications. In a meta-analysis of 50 trials including a total of 9615 patients, the addition of synchronous chemotherapy to radiotherapy for locally advanced SCCHN resulted in an overall survival benefit of 6.5% at five years . However, this is associated with late toxicity and questionable improvement in the therapeutic ratio Radiotherapy acceleration reduces the effect of tumor repopulation. Hypofractionated schedules accelerate treatment by employing fewer but larger radiation dose per fractions (>2Gy per fraction). In the meta analysis, treatment acceleration without total dose reduction (a category including eight trials and 3818 patients) increased ?ve-year loco regional tumor control by 7.3%, but there was no overall survival benefit . Some schedules were associated with an unacceptable increase in acute toxicity and consequential late effects . This is partly due to the use of conventional 2D-planned radiotherapy and should be improved by application of highly conformed volumes, using intensity-modulated radiotherapy (IMRT) or 3Dconformal radiotherapy. In the meta-analysis, treatment acceleration with a reduction in the total dose did not improve loco regional tumor control . However, more than half of patients in this group received the CHART regimen (54 Gy in 36 fractions over 12 days), which can be criticised for an ' over shortening ' of the overall treatment time, where the relative onset of accelerated repopulation between normal mucosa (seven days) and tumor (21 days) was not fully exploited . For ?ve fractions per week, the modeled optimal overall treatment time (to match early and late biologically equivalent doses to obtain greatest tumor effect) is in the range 20- 32 days (approx. 3- 5 weeks) The objective of this study was to investigate hypofractionated 3D CRT with 62.5 Gy in 25 daily fractions over five weeks (2.5 Gy per fractions biologically equivalent dose to the tumor, 70.9Gy 10 and late reacting tissues, 114.6 Gy 3) with synchronous weekly cisplatin 40mg/m2 in patients with stage III (T1-3 N1 or T3N0).And stage IVA,IVB (T1-4N2 orN3)

Tracking Information

NCT #
NCT03880396
Collaborators
Not Provided
Investigators
Principal Investigator: Doaa G Abdelnaser Fathy Mahmoud, Doctor Assiut University Principal Investigator: Hoda H Essa, Doctor Assiut University Principal Investigator: Ola N Abdelfatah, Doctor Assiut University Principal Investigator: Aiat M Mohammed, Doctor Assiut University Principal Investigator: Mohamed O Gad, Doctor Assiut University