Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Experimental Arm B - A-IGRT: Head and neck cancer patients planned for curative radiotherapy with concurrent chemotherapy at Department of Radiation Oncology, Tata Memorial centre, who
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Biopsy proven Squamous cell carcinoma of the oropharynx, hypopharynx and larynx. 2.AJCC stage T1-3, N0-2c, M 0. 3.KPS >= 70. 4.Age >=18 and 5.Patient willing and reliable for follow-up. 6.Patientâ??s nutritional & physical condition compatible with planned therapy. 7.Signed study specific consent form.
Exclusion criteria
Exclusion criteria: 1.T1-2 N0 M0 of Vocal cords 2.History of surgery for the primary or node in head and neck. 3.Evidence of distant metastases or N3 nodal stage. 4.Previous therapeutic irradiation for head & neck cancer. 5.Patients who have received neoadjuvant chemotherapy. 6.Active untreated infection, which preclude the use of systemic chemotherapy or would interfere with completion of treatment. 7.Any histopathology other than Squamous Carcinoma. 8.Primary nasopharyngeal or paranasal sinus cancers. 9.Pregnancy or lactating women. 10.Previous history of malignancy within 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Salivary toxicity at 12 months post radiation: The acute salivary toxicity will be assessed with salivary scintigraphy. The salivary function at 12 months will be determined by the ratio of SEF at 12 months after treatment compared to the baseline SEF (pre-treatment) x 100%.Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the acute and late normal tissue toxicity. 2.To compare the loco-regional control. 3.To compare the disease free survival. 4.To compare the overall survival. 5.To compare the quality of life in patients randomized to the two study arms. 6.To assess parotid shrinkage over time and document the dosimetric changes.Timepoint: 1, 3 , 5 yrs | — |
Countries
India
Contacts
Public ContactDr Sarbani Ghosh Laskar
Tata Memorial Hospital
Outcome results
None listed