| CTRI Number |
CTRI/2024/08/073042 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Palliative radiation with or without chemotherapy in advanced head and neck cancer - a randomised controlled trial |
|
Scientific Title of Study
|
Palliative hypofractionated radiotherapy with or without chemotherapy in locally advanced head and neck squamous cell carcinoma -a randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JIP/IEC/2024/04/80 (Dated-25/06/24) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mruthulagi S P |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER, Puducherry |
| Address |
Department of Radiation Oncology, Regional Cancer Centre RCC, JIPMER, Dhanvantri Nagar, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8838416020 |
| Fax |
|
| Email |
mruthulagisp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shyama Prem |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER, Puducherry |
| Address |
Department of Radiation Oncology, Regional Cancer Centre RCC, JIPMER, Dhanvantri Nagar, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9787814215 |
| Fax |
|
| Email |
shyamaprems1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shyama Prem |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER, Puducherry |
| Address |
Department of Radiation Oncology, Regional Cancer Centre RCC, JIPMER, Dhanvantri Nagar, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9787814215 |
| Fax |
|
| Email |
shyamaprems1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mruthulagi S P |
| Address |
Department of Radiation Oncology, Regional Cancer Centre RCC, JIPMER, Dhanvantri Nagar, Gorimedu, Puducherry |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shyama Prem |
Regional Cancer Centre, JIPMER, Puducherry |
No. 7, Department of Radiation Oncology, Regional Cancer Centre, JIPMER, Puducherry
Pondicherry
PONDICHERRY |
9787814215
shyamaprems1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Palliative hypofractionated radiotherapy in locally advanced head and neck squamous cell carcinoma |
Patients in the control arm will receive Palliative hypofractionated radiotherapy (52.5Gy/15#/3weeks)alone. |
| Intervention |
Palliative hypofractionated radiotherapy with chemotherapy in locally advanced head and neck squamous cell carcinoma |
Patients in the interventional arm will receive Inj.Docetaxel 50mg/m2 and Inj.cisplatin 50mg/m2 iv q2weekly (interval of 2 weeks between each cycle) – 2 cycles(Total duration of 4 weeks) followed by Palliative hypofractionated radiotherapy 52.5Gy/15#/3weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: above 18 years less than 80 yrs.
2. Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx and hypopharynx.
3. Stage: cT4a, T4b, N1-3, M0, and ECOG Performance status: 2-3, planned for palliative radiation.
4. Patient with normal renal, haematological and hepatic parameters. |
|
| ExclusionCriteria |
| Details |
1. Any patient with Stage: cT1-3, N1,2a,b,c, M0, ECOG PS: 0,1, squamous cell carcinoma of the head and neck planned for curative intent treatment- definitive or adjuvant radiation
2. Cancers arising from the salivary gland, nasal cavity, paranasal sinuses and nasopharynx
3.Abnormal renal function (creatinine clearance less than 45 ml/min), haematological parameters (grade 3-4 neutropenia and thrombocytopenia ) and liver function (serum Alkaline Phosphatase more than 6 times the normal upper limit, serum AST +/or ALT more than 3.5 times the normal upper limit)
4.Cardiovascular abnormalities which include prior history of myocardial infarction, angina, dysrhythmias, Coronary Artery Disease(CAD), cardiac failure.
5. Previous history of hypersensitivity to Docetaxel or platinum-containing compounds
6. Recurrent tumors
7. Uncontrolled co-morbidities
8. Non squamous pathology.
9. Prior history of radiation
10. Pregnancy. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the progression-free survival (PFS) in both arms. |
Expected time to follow up - 14 months. Events for PFS will include disease progression, relapse (locoregional or distant), the development of a second primary, or death from any cause. PFS will be defined as the time from random assignment to attainment of an event for PFS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the overall response of the tumour in both arms assessed by contrast-enhanced CT of the head and neck using RECIST 1.1 criteria |
3 months post-treatment |
| 2. To compare the locoregional control (LRC) in both arms assessed by contrast-enhanced CT of the head and neck, using RECIST 1.1 criteria |
6 months and 1 year post-treatment |
| To compare the overall survival (OS) in both arms. |
Events for OS will include death from any cause. OS will be measured from the time of random assignment to death from any cause. |
| 4. To compare the quality of life in both arms using EORTC QOL 30 and EORTC QOL 35 questionnaire version 3.0 |
6 months post radiation. |
| 5. To compare the proportion of patients developing acute and late side effects of radiation using acute and late RTOG toxicity scoring criteria and CTCAE version 5.0 toxicity criteria. |
Weekly during the course of radiation and 3 months post treatment |
| 6. To assess the proportion of patients developing chemotherapy toxicity using CTCAE version 5.0 toxicity criteria. |
Weekly during the course of chemotherapy. |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
05/09/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Palliative radiotherapy
has now become a standard palliative modality in locally advanced head and neck
cancers. In locally advanced cases,
if we have to extend the survival and achieve lasting palliation, enhancing
overall response is crucial. We believe that 5250 cGy in 15 fractions may not
deliver a sufficiently tumoricidal dose, even with concurrent chemotherapy since
most of our patients have very large tumour and nodal volumes at presentation.
Additionally, irradiating only the tumour with the involved nodal region can
lead to recurrences in the adjacent nodal areas.
To address
this, two approaches can be considered:
1. We can consider reducing the tumour volume by giving chemotherapy for
downstaging the tumour before radiation. 2. irradiating not only the
involved nodal region but also the adjacent at-risk levels to an elective dose.
Administering chemotherapy
before radiation has the potential to reduce the tumor volume which in turn,
allows radiation to target a smaller tumor volume, potentially boosting its
effectiveness. Therefore chemotherapy followed by hypofractionated radiotherapy
in locally advanced head and neck cancers is expected to improve the overall
response and progression-free survival resulting in prolonged palliation.
|