| CTRI Number |
CTRI/2018/01/011637 [Registered on: 31/01/2018] Trial Registered Prospectively |
| Last Modified On: |
31/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Optimizing the Radiotherapy plan according to tumor shrinkage in Head and Neck Cancers-A Prilimenary Study |
|
Scientific Title of Study
|
Adaptive Radiotherapy in Head and Neck Cancers-A Prospective Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suman Bhasker |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
R No- 214, Institute Rotary Cancer Hospital, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811093418 |
| Fax |
|
| Email |
drsumanbhasker@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Bhasker |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
R No- 214, Institute Rotary Cancer Hospital, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811093418 |
| Fax |
|
| Email |
drsumanbhasker@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Bhasker |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
R No- 214, Institute Rotary Cancer Hospital, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811093418 |
| Fax |
|
| Email |
drsumanbhasker@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (in the form of exemption of radiotherapy charges and admission if required) |
|
|
Primary Sponsor
|
| Name |
CSIR |
| Address |
CSIR,Library Avenue, Pusa road,New Delhi 110012
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NA |
NA |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suman Bhasker |
All India Institute of Medical Sciences, New Delhi |
Department of Radiotherapy
New Delhi
DELHI |
9811093418
drsumanbhasker@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Head and Neck Cancer patients who will be suitable for Radical Chemo-radiotherapy will be recruited for this study, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ART arm |
Adaptive radiotherapy for locally advanced head and neck cancers |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age > 18 years
Histologically proven squamous cell carcinoma
Written informed consent
Locally advanced head and neck cancers
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome
To evaluate the dosimetric changes in PTV and organs at risk during adaptive radiotherapy.
2.To assess acute and chronic toxicities of treatment.
Secondary Outcome
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
|
| Outcome |
TimePoints |
To assess local control and survival
|
every 3 monthly for local control for 2 years and then 6 monthly for 5 years and survival at 3 and 5 years |
To assess local control and survival
|
every 3 monthly for local control for 2 years and then 6 monthly for 5 years and survival at 3 and 5 years |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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) — 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. |