| CTRI Number |
CTRI/2017/12/010805 [Registered on: 07/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
09/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Outcomes of Stage III and IV Larynx (air pipe) and Hypopharynx (food pipe) Cancers treated with Chemotherapy and Radiation only |
|
Scientific Title of Study
|
Definitive Volumetric Modulated Arc Therapy(VMAT) for Locally Advanced Laryngeal and Hypopharyngeal Squamous Cell Carcinoma: Clinical Outcomes and Toxicity Analysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fathima Almas |
| Designation |
Junior Resident |
| Affiliation |
KMC Manipal |
| Address |
Department of Radiotherapy and Oncology
Shirdi Sai Cancer Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8197132016 |
| Fax |
|
| Email |
fathimaalmas25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Donald Fernandes |
| Designation |
Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Radiotherapy and Oncology
Shirdi Sai Cancer Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922657 |
| Fax |
|
| Email |
donaldjf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Fathima Almas |
| Designation |
Junior Resident |
| Affiliation |
KMC Manipal |
| Address |
Department of Radiotherapy and Oncology
Shirdi Sai Cancer Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8197132016 |
| Fax |
|
| Email |
fathimaalmas25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital Manipal |
| Address |
Manipal, Udupi, Karnataka |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Fathima Almas |
Shirdi Sai Cancer Center, KMC Manipal |
Department of Radiotherapy and Oncology,Shirdi Sai Cancer Center, KMC Manipal
Udupi
KARNATAKA |
8197132016
fathimaalmas25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Stage III or IV laryngeal or hypopharyngeal SCC, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with hypopharyngeal and laryngeal SCC (except T1N0 and T2N0 Glottic cancers), Stages III – IV (AJCC) treated with definitive VMAT |
|
| ExclusionCriteria |
| Details |
1. Patients with laryngeal and hypopharyngeal tumors with histology other than SCC
2. Patients with Stage I/II tumors
3. Patients with distant metastasis
4. Patients undergoing upfront laryngectomy
5. Initial Karnofsky Performance Status (KPS) less than 60%
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To report the loco-regional control (LRC) rate of locally advanced laryngeal and hypopharyngeal cancers treated using definitive VMAT (+ chemotherapy) |
Assessment at 3 monthly intervals |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To report the median laryngectomy free survival on follow-up
2. To report the median distant metastasis free survival on follow-up
3. To report the incidence rate of residual disease at the end of treatment.
4. To report the median overall survival on serial follow-up
5. To report the incidence of acute toxicity with VMAT based IMRT
6. To report the incidence of late toxicity with VMAT based IMRT |
6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
13/09/2017 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Our objectives of this study are to document the loco-regional control rate and the incidence of acute and late toxicities with definitive VMAT (+ chemotherapy) in locally advanced laryngeal and hypopharyngeal cancers. With our analysis we hope to add to the body of knowledge pertaining to the treatment of laryngeal and hypopharyngeal cancers using the VMAT technique. |