| CTRI Number |
CTRI/2024/05/068091 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomised phase III clinical trial to evaluated effect of induction chemotherapy and dysphagia optimized intensity modulated radiotherapy for management of pharyngeal tumors |
|
Scientific Title of Study
|
Induction chemotherapy and dysphagia optimized intensity modulated radiotherapy (DO- IMRT): An integrated approach for management of Pharyngeal Tumours- IC-DARS |
| Trial Acronym |
IC-DARS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul Kumar Gupta |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Radiation Oncology Department, AIIMS Jodhpur, Basni Phase II
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09694657580 |
| Fax |
|
| Email |
atulgupta455@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Pareek |
| Designation |
Additional Professor & HOD |
| Affiliation |
AIIMS Jodhpur |
| Address |
Radiation Oncology Department, AIIMS Jodhpur, Basni Phase II
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996890 |
| Fax |
|
| Email |
drpuneetpareek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Pareek |
| Designation |
Additional Professor & HOD |
| Affiliation |
AIIMS Jodhpur |
| Address |
Radiation Oncology Department, AIIMS Jodhpur, Basni Phase II
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996890 |
| Fax |
|
| Email |
drpuneetpareek@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Basni Phase 2, District-Jodhpur, State- Rajasthan (India)- 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Basni Phase II , Jodhpur (Rajasthan)
Country- India
Pin Code- 342005 |
| Type of Sponsor |
Government 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 |
| Dr Puneet Pareek |
All India Institute of Medical Sciences, Jodhpur |
Radiation Oncology Department (Bunker + OPD 5th floor A Block)
Basni Phase 2, Jodhpur
Jodhpur
RAJASTHAN |
8003996890
drpuneetpareek@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(CLINICAL TRIAL), All India Institute of Medical Sciences, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C13||Malignant neoplasm of hypopharynx, (2) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (3) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (4) ICD-10 Condition: C09||Malignant neoplasm of tonsil, (5) ICD-10 Condition: C10||Malignant neoplasm of oropharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Induction Chemotherapy and Dysphagia Optimized Intensity Modulated Radiotherapy (DO-IMRT) |
Induction chemotherapy of physician choice for 2-3 cycles every 3 weekly will be given as per patients general conditions and labs which will be followed by Dysphagia optimized intensity modulated radiotherapy for 5 weeks |
| Comparator Agent |
Standard Chemoradiotherapy |
In comparator arm, standard chemoradiotherapy with IMRT technique will be delievered for 5 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged 18 years or above
2. Any patient undergoing radiotherapy for head and neck cancer in the oropharynx or hypopharynx.
3.Patients with tumor at other sites where the radical radiotherapy dose is to be delivered to the pharyngeal constrictors may also be eligible
4.Stage T1-4,N03,M0 disease;
5. this will be mostly histologically confirmed squamous cell carcinoma (SCC) but other histological types may be eligible.
6. Radiotherapy with concomitant chemotherapy (unless contra-indicated) is the planned treatment
7.WHO performance status 0 or 1
8. Must be available to attend long term follow up
9.Adequate cognitive ability to complete the questionnaires
10. Written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Documented evidence of pre-existing swallowing dysfunction (not related to head and neck cancer).
2.Previous radiotherapy to the head and neck region.
3.Any contra-indication to Chemotherapy/Radiotherapy
4.Posterior pharyngeal wall, post cricoid or retropharyngeal lymph node involvement.
5.Lateralized tumors, requiring unilateral neck irradiation.
6.Major head and neck surgery (excluding biopsies/tonsillectomy).
7.Current/previous tracheostomy placement.
8.Previous or concurrent illness, which in the investigator’s opinion would interfere with completion of therapy, trial assessments or follow up.
9.Any invasive malignancy within previous 2 years (other than non-melanomatous skin carcinoma or cervical carcinoma in situ)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine, if using induction chemotherapy and dysphagia optimized IMRT (DO-IMRT) to reduce the radiation dose delivered to the dysphagia/aspiration related structures (DARS), improves swallowing function in patients with head and neck cancer treated with radical radiotherapy or chemoradiation. |
weekly assessment during RT delievery and thereafter 0,1,3,6 months post RT completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Local recurrence rate
Locoregional recurrence rate (LRR)
Disease free survival (DFS)
Disease metastases free survival (DMFS)
Overall survival (OS)
Disease specific survival (DSS)
Measurement of the quality of life (QOL)
Assessment of treatment-related toxicity measured by the physicians using standardized common toxicity criteria for adverse events CTCAE, version 5.0
Acute radiation Toxicity (CTCAE 5.0, Pre RT, Post RT)
Comparison of Doses to critical structures
Association of outcomes with HPV status |
weekly assessment during RT delievery and thereafter 0,1,3,6 months post RT completion |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 3 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is Phase 3 randomized controlled open label trial with the hypothesis that While treating patients of pharyngeal tumors with
definitive CTRT, if induction chemotherapy is being given, it will lead to
decrease in tumor volume which will further lead to better sparing of DARS
(Dysphagia and aspiration related structures) while planning Radiotherapy to
the site. It will result in good QOL of the patients and eventually will lead
to good survival outcome. With this hypothesis, appropriate sample size will be recruited after putting in inclusion and exclusion criteria. Comparator arm will be offered standard chemoradiotherapy with IMRT technique while intervention group will be offered induction chemotherapy followed by Dysphagia optimized intensity modulated radiotherapy. During RT, weekly assessment will be done and post RT completion, monthly then 3 monthly assessment will be done. Primary objective is to assess effect of induction chemotherapy and DO-IMRT to reduce radiation dose to dysphagia related structures result in improved quality of life and thereafter improved survival. Secondary objectives are local recurrence rate, locoregional recurrence rate, distant metastasis free survival, association with HPV status, overall survival. |