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Study to compare the effects of a new radiotherapy planning modality which reduces dose to organs involved in swallowing and comparison of this with normal radiotherapy technique which does not focus on reducing dose to swallowing structures in cases of oral cavity cancers after surgery.

Not Applicable
Registration Number
CTRI/2020/01/022774
Lead Sponsor
Dr Ram Manohar Lohia Istitute of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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. <br/ ><br>2. Late toxicities will be assessed after 90 days of start of radiotherapy till last follow up at monthly interval. <br/ ><br>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).
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