Evaluating role of Adaptive radiotherapy in head neck cancers in reducing salivary gland toxicity

Phase 3

Not yet recruiting

Brief Summary: IMRT is widely accepted as the standard treatment for head and neck cancers. As dose application becomes more precise, various factors may lead to a deviation in the intended radiation dose delivery like daily setup variations and geometric and volumetric changes during the course of RT. This inaccuracy may lead to either under dosage of the target volume with resultant risk of tumour recurrence or over dosage of the normal tissues leading potential risk of increased complications. This has led to the development of an adaptive radiation scheme with periodic adjustment of the treatment plan that takes into account such treatment-related anatomic changes and protects parotid glands from an overdose of irradiation.Hence this study is planned to assess the efficacy of adaptive radiotherapy in reducing salivary toxicity in head and neck cancer patients.

Recruitment & Eligibility

Inclusion Criteria

1.Biopsy proven Squamous cell carcinoma of the oropharynx, hypopharynx and larynx.
2.AJCC stage T1-3, N0-2c, M 0.
4.Age â‰¥18 and â‰¤ 70 years.
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

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.
8.Primary nasopharyngeal or paranasal sinus cancers.
9.Pregnancy or lactating women.
10.Previous history of malignancy within 5 years.

Primary Outcome Measures

Name	Time	Method
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%.	1 year

Secondary Outcome Measures

Name	Time	Method
1.To assess the acute and late normal tissue toxicity.	2.To compare the loco-regional control.

Locations (1): Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Sarbani Ghosh Laskar
Principal investigator
9820834386
sarbanilaskar@gmail.com