| CTRI Number |
CTRI/2018/03/012441 [Registered on: 08/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Quality of Life After Conformal Radiotherapy in Late Stage Oral Cavity Cancer:A Prospective clinical Trial |
|
Scientific Title of Study
|
Effect of Hypofractionated Palliative Radiotherapy on Quality of Life in Late Stage Oral Cavity Cancer:A Prospective clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shyama Prem S |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Radiotherapy,RCC, JIPMER, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9345324215 |
| Fax |
|
| Email |
shyamagopalakrishnan@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyama Prem S |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Radiotherapy,RCC, JIPMER, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9345324215 |
| Fax |
|
| Email |
shyamagopalakrishnan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswin Chandran V |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Radiotherapy,RCC, JIPMER, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7639465597 |
| Fax |
|
| Email |
chandiru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Gorimedu, Puducherry - 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institue of Postgraduate Medical Education and research |
| Address |
JIPMER, Gorimedu, Pondicherry |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shyama Prem S |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Radiotherapy, Regional Cancer Centre
Pondicherry
PONDICHERRY |
9345324215
shyamagopalakrishnan@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committe(Human Studies), JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Carcinoma Oral Cavity Stage IV A and IV B fit for palliative treatment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hypofractionated Palliative Radiotherapy |
Hypofractionated Radiotherapy(5250 cGy/15 fractions) will be given for patients with late stage Oral cavity cancer ( Stage IVA and IV B) and their Quality of life will be assessed abefore and after treatment and compared |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
i)Biopsy proven Squamous cell carcinoma
ii)Surgically unresectable stage IVB oral cavity cancer where oral cavity is defined as consisting of lip, alveolus, floor of mouth, hard palate, retromolar trigone, buccal mucosa and tongue (extension to infratemporal fossa extension,masticator space, pterygoid plates, or skull bases or encases internal carotid artery )
iii)Stage IVA disease- not fit for surgery/ curative treatment
iv)Stage IVC disease-for palliation of local symptoms
v)No previous history of radiotherapy/chemotherapy/surgery
vi)No previous history of cancer
|
|
| ExclusionCriteria |
| Details |
i)Patients with another primary at a different site
ii)Pregnant women
iii)Age <18 and >80 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of hypofractionated palliative radiotherapy on quality of life in patients with late stage oral cavity cancer with the EORTC H&N 35 questionnaire with specific attention to pain,swallowing and mouth opening sub scales |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Median survival |
6 months |
| Assessment of general quality of life as per the QLQ C30 and other parameters in the H&N 35 |
2 months
|
| The response rates as assessed by the RECIST guidelines 1.1-complete, partial, overall response rates |
2 months
|
| Acute toxicity during radiation therapy – using RTOG/CTCAE grading. |
2 months |
| Late toxicity using RTOG/CTCAE grading14 |
6 months |
| Compliance to the treatment regimen |
6 months |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2015 |
| Date of Study Completion (India) |
30/06/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Late stage oral cavity cancers can be extremely debilitating and the need for achieving symptomatic relief and local disease control can’t be overstated. Most of these patients have poor performance status, very advanced loco-regional disease , comorbid illnesses, old age or a combination of these factors which make the attempts at radical treatments questionable. The focus should be to identify an optimal palliative radiotherapy schedule which will minimise patient dropout during treatment by minimising side effects and at the same time result in tumor regression and palliation of symptoms. Our experimental arm shall receive a dose of 5250cGy in 15 fractions with a biologically equivalent dose of 5906 cGy with advantages as stated below i) Shortened overall treatment time, and therefore better compliance and less dropouts during treatment. ii)Shortened overall treatment time results in completion of treatment before the tumour repopulation sets in and therefore better tumour control iii) Delivering a biological equivalent dose of around 64 Gy will also ensure adequate tumour regression and improve local control.
We are aiming to assess the quality of life using the EORTC QLQ C30 and H&N 35 questionnaire and the clinical complete response by CT/MRI imaging ( according to RECIST guidelines 1.1), and median survival of the study group.If a 3 week schedule of radiation therapy could be developed which would shorten the treatment time it will enhance the compliance of patients to treatment. A higher dose per fraction can also achieve higher local control thereby leading to prolonged palliation and possibly prolonged survival |