| CTRI Number |
CTRI/2025/01/079104 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study Comparing Radiation Therapy Alone vs Radiation with Additional Drug Treatment for Elderly Patients with Advanced Head and Neck Cancer |
|
Scientific Title of Study
|
Phase III Open Label Randomized Trial Comparing the Addition of Systemic Therapy to Radical Radiation with Radiation Therapy Alone in Elderly Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck |
| 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 Nandini Menon |
| Designation |
Associate Professor and Medical Oncologist |
| Affiliation |
Tata Memorial Centre |
| Address |
OPD No 204 2nd Floor Homi Bhabha Block Medical Oncology Department Tata Memorial centre Dr E Borges Marg Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769178270 |
| Fax |
|
| Email |
nandini.menon1412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandini Menon |
| Designation |
Associate Professor and Medical Oncologist |
| Affiliation |
Tata Memorial Centre |
| Address |
OPD No 204 2nd Floor Homi Bhabha Block Medical Oncology Department Tata Memorial centre Dr E Borges Marg Parel
MAHARASHTRA
400012
India |
| Phone |
9769178270 |
| Fax |
|
| Email |
nandini.menon1412@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dilan Davis |
| Designation |
SENIOR RESIDENT III |
| Affiliation |
Tata Memorial Centre |
| Address |
OPD No 204 2nd Floor Homi Bhabha Block Medical Oncology Department Tata Memorial centre Dr E Borges Marg Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8848017945 |
| Fax |
|
| Email |
dilandavis@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre Dr E Borges Marg Parel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
DR E Borges Marg Parel Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav Kumar |
Homi Bhabha Cancer Hospital and Research Center, Muzaffarpur |
Department of Medical Oncology , Room no. 214, HBCH&RC, SKMCH Campus, Uma Nagar, Rasulpur, Bihar, Muzaffarpur, 842004
Muzaffarpur
BIHAR |
9264493969
kumarg@hbchrcmzp.tmc.gov.in |
| Dr Bal Krishna Mishra |
Mahamana Pandit Madan Mohan Malaviya Cancer centre |
OPD 22, Ground floor,
Department of Medical
Oncology, Banaras Hindu
University Campus, Sundar
Bagiya Colony, Sundarpur,
Varanasi, Uttar Pradesh 221005
Varanasi
UTTAR PRADESH |
9415214254
bkmmishra@hotmail.com |
| Dr Nandini Menon |
Tata Memorial Centre |
OPD No 204 2nd Floor Homi Bhabha Block Tata Memorial Centre Dr E Borges Marg Parel Mumbai
Mumbai
MAHARASHTRA |
09769178270
nandini.menon1412@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (2) ICD-10 Condition: C000||Malignant neoplasm of external upper lip, (3) ICD-10 Condition: C030||Malignant neoplasm of upper gum, (4) ICD-10 Condition: C031||Malignant neoplasm of lower gum, (5) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (6) ICD-10 Condition: C040||Malignant neoplasm of anterior floor of mouth, (7) ICD-10 Condition: C041||Malignant neoplasm of lateral floor of mouth, (8) ICD-10 Condition: C048||Malignant neoplasm of overlappingsites of floor of mouth, (9) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (10) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (11) ICD-10 Condition: C051||Malignant neoplasm of soft palate, (12) ICD-10 Condition: C052||Malignant neoplasm of uvula, (13) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (14) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (15) ICD-10 Condition: C061||Malignant neoplasm of vestibule ofmouth, (16) ICD-10 Condition: C062||Malignant neoplasm of retromolar area, (17) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (18) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (19) ICD-10 Condition: C090||Malignant neoplasm of tonsillar fossa, (20) ICD-10 Condition: C091||Malignant neoplasm of tonsillar pillar (anterior) (posterior), (21) ICD-10 Condition: C098||Malignant neoplasm of overlappingsites of tonsil, (22) ICD-10 Condition: C099||Malignant neoplasm of tonsil, unspecified, (23) ICD-10 Condition: C100||Malignant neoplasm of vallecula, (24) ICD-10 Condition: C101||Malignant neoplasm of anterior surface of epiglottis, (25) ICD-10 Condition: C102||Malignant neoplasm of lateral wallof oropharynx, (26) ICD-10 Condition: C103||Malignant neoplasm of posterior wall of oropharynx, (27) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (28) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (29) ICD-10 Condition: C130||Malignant neoplasm of postcricoidregion, (30) ICD-10 Condition: C131||Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect, (31) ICD-10 Condition: C132||Malignant neoplasm of posterior wall of hypopharynx, (32) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Definitive radiation conventional or altered fractionation |
Doses
Adjuvant RT
For 2DRT
Phase1 46 Gy/23 fractions, 2Gy/#, one fraction per day
Phase 2: 14 Gy/ 7 fractions, 2Gy/#, one fraction per day
Total dose to be 60 Gy/ 30 fractions/ 6 weeks
ForIMRT:
Prescription dose should follow the ICRU 50 report. PTV1: A total dose of 44-46 Gy in 22-23 fractions over a total 5.5 weeks (Equivalent: 2
Gy/fraction, 5 fractions per week)
PTV2: A total dose of 60 Gy in 30 fractions over a total 6 weeks (2 Gy/fraction, 5 fractions per
week)
Definitive
RTFor
2DRT:
Phase1: 40-46 Gy/20-23 fractions, 2Gy/#, one fraction per day
Phase 2: 24-30 Gy/12-15 fractions, 2Gy/#, one fraction per day
Protocol Version 4.0 dated 31.10.2024 17Total dose to be 70 Gy/ 35 fractions/ 7 weeks or biologically equivalent dose
ForIMRT:
Prescription dose should follow the ICRU 50 report. PTV1: A total dose of 50 Gy in 25 fractions over a total 5 weeks (2 Gy/fraction, 5 fractions per
week)
PTV2: A total dose of 70 Gy in 35 fractions over a total 7 weeks (2 Gy/fraction, 5 fractions
perweek) |
| Intervention |
Definitive radiation conventional or altered fractionation plus weekly docetaxel or cisplatin |
Definitive radiation conventional or altered fractionation Plus weekly docetaxel 15 mg per m2for maximum of 7 cycles or cisplatin 40mgbper m2
Doses Adjuvant RT For 2DRT Phase1 46 Gy/23 fractions, 2Gy/#, one fraction per day Phase 2: 14 Gy/ 7 fractions, 2Gy/#, one fraction per day Total dose to be 60 Gy/ 30 fractions/ 6 weeks ForIMRT: Prescription dose should follow the ICRU 50 report. PTV1: A total dose of 44-46 Gy in 22-23 fractions over a total 5.5 weeks (Equivalent: 2 Gy/fraction, 5 fractions per week) PTV2: A total dose of 60 Gy in 30 fractions over a total 6 weeks (2 Gy/fraction, 5 fractions per week) Definitive RTFor 2DRT: Phase1: 40-46 Gy/20-23 fractions, 2Gy/#, one fraction per day Phase 2: 24-30 Gy/12-15 fractions, 2Gy/#, one fraction per day Protocol Version 4.0 dated 31.10.2024 17Total dose to be 70 Gy/ 35 fractions/ 7 weeks or biologically equivalent dose ForIMRT: Prescription dose should follow the ICRU 50 report. PTV1: A total dose of 50 Gy in 25 fractions over a total 5 weeks (2 Gy/fraction, 5 fractions per week) PTV2: A total dose of 70 Gy in 35 fractions over a total 7 weeks (2 Gy/fraction, 5 fractions perweek) |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than65 years, no maximum age
2. Stage III or IV disease without evidence of distant metastases.
3. Participants must have a histologically confirmed stage III-IV squamous cell cancers of the
head and neck region.
4. Participants must warrant CTRT
5. Participants must have malignancy arising from one of the following sites oral cavity,
pharynx (inclusive of oropharynx, hypopharynx) or larynx (inclusive of supraglottis, glottis
and subglottis) or CUP (carcinoma unknown primary) with neck nodes
6. ECOG performance status less than and equal to 2
7. Participants must have normal organ and marrow function
8.The effects of chemotherapy on the developing human fetus are teratogenic. Hence
women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. Should a woman become pregnant or suspect she is
pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree
to use adequate contraception prior to the study, for the duration of study participation,
and 3 months after completion of protocol.
9. Both men and women of all races and ethnic groups are eligible for this trial.
10. Willing and able to comply with all study requirements
11. Ability to understand and the willingness to sign a written informed consent document |
|
| ExclusionCriteria |
| Details |
1. Patientswith contraindications to radiotherapy. 2. Life expectancy less than 6 months.
3. Patients with active second malignancies, apart from skin cancers and cervical
intraepithelial neoplasia.
4. Patients on other investigational drugs within the last 30 days
5. Patients who cannot follow up and can take all the cycles of chemotherapy at the
participating institution.
6. Patients with uncontrolled comorbidities precluding the use of docetaxel and cisplatin.
7. HIV-positive with CD4 count less than 200 may be excluded
8. Primary sites of malignancy are major salivary glands, nasopharynx or skin.
9. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to any agents used in study. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PFS |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.OS
2. Locoregional Control
3.acute and late toxicity
4.compliance
5.TOI |
1.at end of study
2 every visit
3.every visit
4.every visit
5.6 months, 12 months and at 24 months
|
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
31/01/2025 |
| 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)
|
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
|
Locally advanced squamous cell carcinoma of the head and neck (LAHNSCC) presents a significant clinical challenge due to its poor prognosis and limited treatment options. While concurrent chemoradiation (CRT) has emerged as the standard of care for the disease, elderly patients often face unique challenges in tolerating cisplatin-based CRT. Concurrent chemoradiation plays a crucial role in improving survival rates in locally advanced head and neck squamous cell carcinoma. However, cisplatin-based CRT may not be suitable for all patients, especially the elderly. Docetaxel-based CRT offers a more tailored approach for cisplatin-ineligible or high-risk patients. Hence further research is essential to refine treatment strategies and improve outcomes for elderly patients with LAHNSCC. This is a Phase 3 open label randomized trial to compare the addition of systemic therapy to radical radiation with radiation therapy alone in elderly patients of locally advanced squamous cell carcinoma of the head and neck. A total of 300 participants will be included in the study who are detected with cancer of the head and neck that is locally advanced and are planned for treatment. There will be predefined inclusion and exclusion criteria by which participants will be enrolled. The study aims to compare chemoradiation (with cisplatin or docetaxel) and radiation alone in elderly patients with advanced head and neck cancers. It also aims to understand the overall survival, acute as well as late toxicities. The total duration of the study is 2 years. Initial 6-7 weeks will be the treatment period after which you will be asked to come for check-up and response assessment at 12 weeks post- treatment completion. Thereafter you will be followed up every 3 months for the first year, 4monthly for 2nd year, Every 6-7 monthly for 3 rd year, Every 12-18 monthly for post 5 th year |