| CTRI Number |
CTRI/2012/06/002717 [Registered on: 06/06/2012] Trial Registered Retrospectively |
| Last Modified On: |
08/08/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
We are comparing two arm of treatment ,compare short course palliative Radiotherapy with short course concurrent palliative Chemotherapy plus radiotherapy in advanced and unresectable head and neck cancer . |
|
Scientific Title of Study
|
A Phase 2 randomized study to compare short course palliative Radiotherapy with short course concurrent palliative Chemotherapy plus radiotherapy in advanced and unresectable head and neck cancer . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arvind Kumar |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 229 2nd floor,
Deptt of Medical Oncology,
Inst Rotary Cancer Hospital,
All India Institute of Medical Sciences
Room no 229 2nd floor,
Deptt of Medical Oncology,
Inst Rotary Cancer Hospital,
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
9871584654 |
| Fax |
01126589490 |
| Email |
hidrarvind@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul sharma |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 229 2nd floor,
Deptt of Medical Oncology,
Inst Rotary Cancer Hospital,
All India Institute of Medical Sciences
Room no 229 2nd floor,
Deptt of Medical Oncology,
Inst Rotary Cancer Hospital,
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
01126589490 |
| Fax |
01126589490 |
| Email |
atul1@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arvind Kumar |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 229 2nd floor,
Deptt of Medical Oncology,
Inst Rotary Cancer Hospital,
All India Institute of Medical Sciences
Room no 229 2nd floor,
Deptt of Medical Oncology,
Inst Rotary Cancer Hospital,
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
9871584654 |
| Fax |
01126589490 |
| Email |
hidrarvind@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Inst Rotary Cancer Hospital,
All India Institute of Medical Sciences,Ansari Nagar,New Delhi 110029.India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| All India Institute of medical Sciences |
Inst Rotary Cancer Hospital,
All India Institute of Medical Sciences,Ansari Nagar,New Delhi 110029,India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arvind Kumar |
institute rotary cancer hospital,all india institute of medical sciences |
room no 229 2nd floor,Institute Rotary Cancer Hospital,AIIMS,Ansari Nagar,New Delhi 11029.
South
DELHI |
9871584654
01126589490
hidrarvind@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Head and Neck Cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
short course of concurrent palliative chemotherapy plus radiotherapy |
Inj Cisplatin @ 6mg/m2 IV push in 50 ml normal saline over 10 minutes D1-D5 along with radiotherapy 20gray 5 fractions. |
| Comparator Agent |
short course of palliative radiotherapy |
short course of palliative radiotherapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
A Biopsy proven Squamous cell carcinoma of the Head and Neck region.
B ECOG Performance Status of 1/2/3.
C T4b and /or N3 TUMOUR that had been unanimously defined as inoperable and incurable by multidisciplinary team members.
D Sites –oral cavity, oropharynx, hypopharynx.
|
|
| ExclusionCriteria |
| Details |
A Patients with ECOG PS 4
B Non-squamous histology.
C H/o previous malignancy at same or other site.
D Patients who has received Radiotherapy or Chemotherapy in the past either from IRCH or from other centre.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess locoregional disease control at 6 months between patients with short course palliative Radiotherapy PRT versus patients with short course concurrent palliative Chemotherapy plus radiotherapy CTRT in advanced and unresectable head and neck cancer.
2.Proportion of patients eligible for radical RT versus radical CT and RT in each treatment arm.
|
6 months from the date of randomization. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess for degree of symptom relief & palliation between two groups.
2. To compare progression free survival and overall survival between two groups
3. To compare toxicity between two groups.
|
at one month and six month. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/03/2012 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Head and Neck cancer (HNSCC )patients present as advance and incurable stage in nearly 30-35% in India.These patients are neither suitable for surgery nor fit for curative RT or chemo-RT approaches.At the same time these advance HNSCC patients are not well defined in Western literature.These patients are similar to lung,Esophagus,Gall Bladder and need Palliative anti-cancer therapy and/or best supportive care.If adding concurrent IV bolus chemotherapy gives an added advantage over palliative RT with toxicities that are acceptable than it will have paradigm change in therapeutic modality in such a group of patients,which comprises nearly one third of HNSCC patients in a country with limited resources. |