IMRT - adjuvant concurrent CRT/ RTommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphaticsCisplatin
IMRT - adjuvant concurrent CRT/ RT: IMRT - adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr to primary and regional lymphatics
ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics: IMRT- adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr / Brachytherapy 40-48 Gy in10-12 fractions twice daily at least 6 hours apart, to primary tumor bed only
\- elimination of regional lymphatics
Cisplatin: Cisplatin is a antineoplastic drug, will be given during the radiation at a dose of 40 mg/m2 weekly to a cumulative dose of at least 200 mg/m2 in case of margin positive disease.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Aged 18 or above and less than 70 years
2. Stage pT1-4histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral/bilateral neck dissection.
3. Patient with high risk features: positive or close (≤ 5mm) margin, presence of LVI or PNI, pT3-4
4. At least one dissected hemi-neck (at least 12 nodes recovered in one dissected hemi-neck)
5. Pathological N0/ N1 neck and high risk features undergoing radiotherapy for HNSCC of the oral cavity
6. Brandwein-Gensler (BG) histological risk assessment in all patients
7. Karnofsky performance score greater or equal 70
8. Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version.
9. Timely delivery of PORT preferable within 6weeks of surgery (upto 1-2 weeks of delay beyond 6 weeks is permissible to accommodate for delayed wound healing or other logistics)
10. Written informed consent for treatment.
11. Available to attend long term follow- up
Exclusion Criteria:
1. Non squamous histology
2. Presences of distant metastases
3. pT1-2 disease and no high risk features
4. Pathologically N2/N3 disease.
5. Patients that require re-irradiation for recurrent disease
6. Inadequate neck dissection (less than 12 nodes examined)
7. Primary tumor reaching midline (within 1 cm from midline) and only ipsilateral neck dissection done
8. Initiation of PORT after 8 weeks of radical surgery.
9. Previous radiotherapy to the head and neck region
10. Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).
11. Age \< 18 years or \> 70 years
12. Brandwein-Gensler (BG) histological risk not done
Primary outcome measure(s)
Regional control — 2 years Regional control will be assessed as occurrence of any new lesion in the regional /nearby area over time with the help of radiological imaging (CT/MRI/PET-CT) and clinical examination.
will be assessed at 3 months, 6 months, 12 months, 18 months, 24 months
Trial sites (1)
Facility
City
Region
Status
Nci, Aiims
Jhajjar
Haryana
Recruiting
More All India Institute of Medical Sciences trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.