To compare two advanced high-precision radiotherapy techniques in head and neck cancers.

Phase II study of 3-Dimensional conformal Radiotherapy (3D-CRT) vs. Intensity Modulated Radiotherapy (IMRT) for Squamous Cell Carcinoma of the Head and Neck (HNSCC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000045

Enrollment

Registered

2008-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Intensity modulated radiation therapy: Gross disease-66 Gy/30 fractions

Highrisk elective nodal volume-60 Gy/30 fractions

Lowrisk elective nodal volume-50 Gy/25 fractions Control Intervention1: 3D conformal radiation therapy: Gross disease-70 Gy/35 fractions

Lowrisk elective nodal volume-54 Gy/30 fractions

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age > 18 and < 65 2)Biopsy proven squamous cell carcinoma of the oropharynx. 3)AJCC stage T1-3, N0-N2b, M0 patients with pre-treatment tumor measurements clinically as well as on CT/MRI scans. 4)Surgery of the primary tumor limited to excisional or incisional biopsy. 5)No form of neck dissection for nodal metastases. 6)KPS >=60 7)No prior history of therapeutic irradiation 8)Patient willing and reliable for follow-up 9)Patients nutritional & physical condition compatible with planned therapy 10)Signed study specific consent form

Exclusion criteria

Exclusion criteria: 1)Evidence of distant metastasis 2)Previous therapeutic irradiation for head & neck cancer or any other invasive cancer other than squamous or basal cell carcinoma of the skin 3)History of prior malignancy 4)Prophylactic use of amifostine or pilocarpine 5)Active untreated infection like tuberculosis, which preclude the use of systemic chemotherapy or wound interfere with completion of the treatment 6)Any histopathology other than squamous carcinoma 7)Primary nasopharyngeal carcinoma 8)Age <18 or > 65 years 9)Pregnancy or lactating

Design outcomes

Primary

Measure	Time frame
Acute Salivary Gland Toxicity (>= Gr.2) as per the RTOG toxicity criteria.Timepoint: 3 months	—

Secondary

Measure	Time frame
Local control & Loco-Regional control Disease-Free Survival & Overall Survival Timepoint: 5 years	—

Countries

India

Contacts

Public ContactDr. Tejpal Gupta

Assistant Professor

tgupta@actrec.gov.in91-22-27405057

Outcome results