Health Condition 1: C021- Malignant neoplasm of border of tongue Health Condition 2: C060- Malignant neoplasm of cheek mucosa Health Condition 3: C020- Malignant neoplasm of dorsal surface of tongue Health Condition 4: C03- Malignant neoplasm of gum Health Condition 5: C050- Malignant neoplasm of hard palate Health Condition 6: C06- Malignant neoplasm of other and unspecified parts of mouth Health Condition 7: C02- Malignant neoplasm of other and unspecified parts of tongue Health Condition 8: C
Conditions
Interventions
Intervention1: Dysphagia optimised-IMRT: Dose constraints to Dysphagia Aspiration Related Structures (DARS)
Control Intervention1: Standard-IMRT: Dose constraints not given to Dysphagia Aspiration rel
Sponsors
Dr Ram Manohar Lohia Istitute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Post operative patients of oral cavity cancer with histopathology of squamous cell carcinoma (excluding lip). 2. Patients willing to give written informed consent 3. Karnofsky performance status 70 or above 4. One or more of the following risk factors: a. pT3/pT4 b. Node positive c. Close margin(1-5mm) d. Perineural invasion present e. Lympho-vascular invasion present f. Depth of invasion more than or equal to 3mm for tongue and more than or equal to 7 mm for buccal mucosa g. High grade tumor 5. Patients with indications for chemo-radiation but who are a. unfit for chemotherapy due to associated comorbid conditions b. unfit for chemotherapy due to poor GC c. unwilling to undergo chemotherapy 6. Non metastatic disease. 7. Patients taking oral feed at the time of commencement of radiation
Exclusion criteria
Exclusion criteria: 1. Patients who have received neoadjuvant chemotherapy. 2. Any histopathology other than SCC 3. Previous radiotherapy to the head and neck region 4. Patients with absolute indications for concurrent chemoradiotherapy 5. Synchronous or metachronous malignancy 6. Pregnant or lactating women 7. Uncontrolled concurrent illness like DM, HTN, tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare acute swallowing toxicity in post operative oral cavity carcinoma patients treated with Do-IMRT versus S-IMRT.Timepoint: This will be assessed weekly from the day of start of radiotherapy till completion of radiotherapy. After completion of radiotherapy, acute toxicities will be assessed monthly till 90 days from start of radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare other acute and late toxicities, and loco-regional control in patients treated with Do-IMRT versus S-IMRT.Timepoint: 1. Other acute toxicities will be assessed weekly from the day of start of radiotherapy till completion of radiotherapy. After completion of radiotherapy, acute toxicities will be assessed monthly till 90 days from the start of radiotherapy. 2. Late toxicities will be assessed after 90 days of start of radiotherapy till last follow up at monthly interval. 3.Loco-regional control will be assessed at 6 months after completion of radiotherapy or at the time of last follow up (whichever is later). | — |
Countries
India
Contacts
Public ContactDr Ayushi Patni
Dr. Ram Manohar Lohia Institute of Medical Sciences
Outcome results
None listed