| CTRI Number |
CTRI/2023/10/058621 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Higher cumulative dose, 6days/week vs standard, 5days/week moderately hypofractionated palliative radiotherapy with concurrent chemotherapy in locally advanced head and neck carcinoma. |
|
Scientific Title of Study
|
Accelerated Hypofractionated Palliative Radiotherapy Vs Standard Hypofractionated Palliative Radiotherapy With Concurrent Chemotherapy In Locally Advanced Head And Neck Carcinoma: A Randomised Controlled Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanvi Gupta |
| Designation |
Junior Resident (Academic), Deptt of Radiation Oncology, AIIMS, New Delhi |
| Affiliation |
Department of Radiation Oncology, AIIMS, New Delhi |
| Address |
Department of Radiation Oncology, Dr.BRAIRCH, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9818694450 |
| Fax |
|
| Email |
tanvigupta7991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Bhasker |
| Designation |
Professor, Deptt of Radiation Oncology, AIIMS, New Delhi |
| Affiliation |
Department of Radiation Oncology, AIIMS, New Delhi |
| Address |
Department of Radiation Oncology, Dr.BRAIRCH, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9811093418 |
| Fax |
|
| Email |
drsumanbhasker@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Bhasker |
| Designation |
Professor, Deptt of Radiation Oncology, AIIMS, New Delhi |
| Affiliation |
Department of Radiation Oncology, AIIMS, New Delhi |
| Address |
Department of Radiation Oncology, Dr.BRAIRCH, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9811093418 |
| Fax |
|
| Email |
drsumanbhasker@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
AIIMS, New Delhi- 110029, India |
| 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 Tanvi Gupta |
AIIMS, New Delhi-110029 |
1st floor, RT ward, Department of Radiation Oncology, DR. BRAIRCH
New Delhi
DELHI |
9818694450
tanvigupta7991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00||Malignant neoplasm of lip, (2) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (3) ICD-10 Condition: C02||Malignant neoplasm of other and unspecified parts of tongue, (4) ICD-10 Condition: C04||Malignant neoplasm of floor of mouth, (5) ICD-10 Condition: C09||Malignant neoplasm of tonsil, (6) ICD-10 Condition: C03||Malignant neoplasm of gum, (7) ICD-10 Condition: C05||Malignant neoplasm of palate, (8) ICD-10 Condition: C10||Malignant neoplasm of oropharynx, (9) ICD-10 Condition: C13||Malignant neoplasm of hypopharynx, (10) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Accelerated hypofractionated palliative radiotherapy with concurrent weekly cisplatin. This would be followed by radical conversion in case of partial to complete response. |
42Gy in 12 fractions over 2 weeks with 6 fractions per week will be administered with weekly concurrent cisplatin at a dose of 40mg/m2 IV. After 3 weeks of Palliative Radiotherapy completion, response assessment will be done using CECT head and neck and radical conversion will be done in case of partial to complete response upto EQD2 dose of 70Gy. |
| Comparator Agent |
Standard hypofractionated palliative radiotherapy with concurrent daily cisplatin. This would be followed by radical conversion in case of partial to complete response. |
20Gy in 5 fractions over 5 days will be administered with daily concurrent cisplatin at a dose of 6mg/m2 IV. After 3 weeks of palliative radiotherapy completion, response assessment will be done using CECT Head and Neck and radical conversion will be done in case of partial to complete response upto EQD2 dose of 70Gy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-Treatment naive, Histo-pathologically proven Squamous Cell Carcinoma of head and neck region excluding nasopharyngeal, para-nasal sinus and salivary gland primary
-Defined as incurable or palliative intent by Head and Neck multidisciplinary team (MDT)
-Adequate organ functions and bone marrow reserve
-Eastern Co-operative Oncology Group Performance Score (ECOG PS)- (0-3)
-Age: 18- 70 years
-Negative viral serology markers (HIV, HBsAg, HCV)
-Giving written Informed consent
|
|
| ExclusionCriteria |
| Details |
-Nasopharyngeal, para-nasal sinus or salivary gland primary
-Recurrent disease
-Metastatic disease
-Patients who have previously received oncologic treatment with surgery, radiotherapy or chemotherapy
-Pregnant patients
-Synchronous malignancy or any other malignancy with in last 5 years
-Known uncontrolled medical comorbidities which could impact QOL
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tumour Response Rate
Quality of Life |
Tumor Response- 3 weeks, 3 months, 6 months after palliative radiotherapy completion.
Quality of Life- baseline, 3 months, 6 months after palliative radiotherapy completion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Progression Free Survival |
6 months |
| Overall Survival |
6 months |
| Assessment of Acute Toxicities |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/10/2023 |
| 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)
|
Not Applicable |
| 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
|
In patients with locally advanced head and neck carcinoma, Palliative
radiotherapy, in general, has the potential to greatly improve the quality of
life (QoL) of these patients and may actually increase overall survival. Considerations
for an optimal palliative radiotherapy schedule are: significant tumour
regression and symptom control within a short overall treatment time (OTT) with
minimal side effects. Frequently some form of hypofractionation is opted for.
The benefit of an increased tumour cell kill because of the large fraction size
in a short OTT is counteracted, from radiobiological point of view, by an
increased potential for late side effects. However, late radiation toxicity is
often less relevant in patients treated in palliative setting. Accelerated fractionation
is another option. The rationale for accelerated fractionation is that
reduction in overall treatment time decreases the opportunity for tumour cell
regeneration, thereby increasing the probability of tumour control for a given
total dose. Because overall treatment time has little influence on the
probability of late normal tissue injury, a therapeutic gain should be
realized, provided the interval between dose fractions is sufficient for
complete repair to take place. The
present study has been designed to address the benefit of accelerated moderately-hypofractionated
palliative radiotherapy with concurrent chemotherapy over standard hypofractionated
palliative radiotherapy with concurrent chemotherapy on the background of
previous study from this centre. |