Optimizing the Radiotherapy plan according to tumor shrinkage in Head and Neck Cancers-A Prilimenary Study

Not yet recruiting

Conditions: Head and Neck Cancer patients who will be suitable for Radical Chemo-radiotherapy will be recruited for this study

Registration Number: CTRI/2018/01/011637

Lead Sponsor: CSIR

Brief Summary: Head and neck cancers (HNC) constitute one of the most common cancers in the developing world. In a recent study from India, of approximately 556,400 cancer deaths in the year 2010, the most fatal cancers were HNC. Radiotherapy plays a central role in treatment of locally advanced head and neck cancers (LAHNC). Over the years, the delivery of radiation therapy has improved with innovations that have reduced toxicity without compromisÂing loco-regional control. Among these advances, the development of intensity-modulated radiation therapy (IMRT) has represented a major turning point in the treatment of HNC patients.

Several factors may result in set-up uncertainties and a potentially decreased therapeutic ratio such as patient repositioning on the treatment table, weight loss, tumor and lymph node shrinkage, tissue swelling and lymphedema, and alteration of fat distribution. More recently, image guidance has been used for adaptive radiotherapy (ART) â€” the adjustment of treatment planning durÂing the course of radiation to account for anatomic changes and improves the theraÂpeutic index.

**Why is ART necessary?**

In literature, some studies have reported volumetric changes during adaptive planning. Barker et al have reported a median GTV reduction at a rate of 0.2 cm3 per day, corresponding to a 70% reduction on the last day of RT.

ART is conceptually an attractive approach to account for and correct tumour and normal tissue variations during treatment, but at present, there are limited data to guide its clinical application in day-to-day practice. This study will help in designing institutional protocol and will give useful scientific data for further studies.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Age > 18 years Histologically proven squamous cell carcinoma Written informed consent Locally advanced head and neck cancers.

Exclusion Criteria

1.Resection of primary tumor 2.Delivery of induction chemotherapy prio to radiation 3.Prior history of malignancy 4.History of prior radiation 5.KPS <70.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome	weekly during treatment then at 1 month, 3 monthly for 2 years and 6 monthly for 5 years
To evaluate the dosimetric changes in PTV and organs at risk during adaptive radiotherapy.	weekly during treatment then at 1 month, 3 monthly for 2 years and 6 monthly for 5 years
Secondary Outcome	weekly during treatment then at 1 month, 3 monthly for 2 years and 6 monthly for 5 years
2.To assess acute and chronic toxicities of treatment.	weekly during treatment then at 1 month, 3 monthly for 2 years and 6 monthly for 5 years
To assess local control and survival	weekly during treatment then at 1 month, 3 monthly for 2 years and 6 monthly for 5 years

Secondary Outcome Measures

Name	Time	Method
Primary outcome	To evaluate the dosimetric changes in PTV and organs at risk during adaptive radiotherapy.
To assess local control and survival

Trial Locations

Locations (1): All India Institute of Medical Sciences, New Delhi
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Dr Suman Bhasker
Principal investigator
9811093418
drsumanbhasker@gmail.com