| CTRI Number |
CTRI/2025/08/092583 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Metronomic chemotherapy in head and neck cancers |
|
Scientific Title of Study
|
A single arm feasibility study of Metronomic Chemotherapy(etoposide plus methotrexate + celecoxib- ETOMEC) in Advanced, Inoperable, and Metastatic Head and Neck Squamous Cell Carcinoma |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Sundriyal |
| Designation |
Associate Professor |
| Affiliation |
All Indi Institute of Medical Sciences |
| Address |
Department of Medical Oncology Hematology
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9968175838 |
| Fax |
|
| Email |
drdeepaksundriyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak Sundriyal |
| Designation |
Associate Professor |
| Affiliation |
All Indi Institute of Medical Sciences |
| Address |
Department of Medical Oncology Hematology
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9968175838 |
| Fax |
|
| Email |
drdeepaksundriyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Sundriyal |
| Designation |
Associate Professor |
| Affiliation |
All Indi Institute of Medical Sciences |
| Address |
Department of Medical Oncology Hematology
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9968175838 |
| Fax |
|
| Email |
drdeepaksundriyal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of MEdical sciences, Rishikesh, Dehradoon,Uttarakhand India, 249203 249203 |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Manav Seva Samiti, Delhi |
| Address |
35, Himalaya Apartment, IP extension, New Delhi, 110092 |
| Type of Sponsor |
Other [Non governmental organisation] |
|
|
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 Deepak Sundriyal |
All India Institute Of Medical Sciences |
Room no 016513, Department of Medical Oncology Hematology
Dehradun
UTTARANCHAL |
09968175838
drdeepaksundriyal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of MEdical Sciences, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (2) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (3) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (4) ICD-10 Condition: C140||Malignant neoplasm of pharynx, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
etoposide, methotrexate, celecoxib |
Methotrexate Tablet (15 mg/m2) PO on day 1 , day 8, day 15
Etoposide capsule 50 mg PO daily day 1 to day 14
Celecoxib Capsule 200 mg PO twice a day x 21 days
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with histologically or cytologically confirmed squamous cell carcinoma of the head and neck region
2. Locally advanced or metastatic tumor unsuitable for loco-regional therapy (involvement of skull base, prevertebral fascia, major vessels, gross mandibular erosion, oro-cutaneous fistula, or extensive disease which cannot be safely encompassed in radiation field). Palliative radiation for pain relief is acceptable. Patients who have taken prior lines of therapies are included provided they have a documented progression.
3. Age 18 years to 80 years.
4. Eastern Cooperative Oncology Group performance status 0, 1, 2.
5. Measurable disease as defined by response evaluation criteria in solid tumors (version 1.1) (7)
6. Adequate bone marrow function: Absolute Neutrophil Count (ANC) more than 1,500, platelets more than 100,000, hemoglobin more than 8 g)
7. Creatinine clearance using Cockroft Gault formula more than 45 ml/min
8. Adequate hepatic function: bilirubin less than 1.5 x UNL SGOT PT less than 30 or below the reference range of the lab
9. Adequate cardiac function as decided by clinical examination.
10. Women should use contraceptive medication for 6 months after the end of the study or she would be post-menopause status. Men should consent with the contraception for 6 months after the end of the study or he would be infertile.
11. Have financial constraints for immunotherapy or cetuximab based therapy
12. Patients should sign a written informed consent before study entry.
|
|
| ExclusionCriteria |
| Details |
1. Histologic types other than squamous cell or the primaries in the thyroid, salivary glands and nasopharynx should be excluded.
2.Decompensated, cardiac, pulmonary, renal, immunological disease, psychiatric illness, active tuberculosis and those seropositive for HIV, HBV and HCV not on treatment.
3. Those who have received methotrexate or etoposide in the prior lines of therapy or on celecoxib for any other reason.
4. Pregnant or lactating women, women of childbearing potential not employing adequate contraception.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the objective response rate (ORR) to oral etoposide, methotrexate and celecoxib combination in the locally advanced, inoperable, and metastatic head and neck cancer patients. |
response evaluation to be done after completion of
4 cycles
8 cycles
12 cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical benefit rate (CBR) of this regimen
Progression free survival (PFS) of this regimen
Toxicity associated with this regimen
|
Last patient enrollment date 36 months from the date of IEC approval
Data analysis 4 months
Preparation of final report 2 months
|
| nil |
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="3"
Months="6"
Days="20" |
|
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
|
Metronomic chemotherapy defined as the frequent administration of drug doses designed to maintain a low but active range of concentrations of chemotherapeutic agents during prolonged periods of time without inducing excessive toxicities. This includes a 2-drug regimen of methotrexate and celecoxib with a response rate of 12-13% in head and neck cancers. We hypothesize that a combination of oral etoposide, methotrexate and celecoxib can lead to an improvement in the response rate from 12-25% in patients with locally advanced, inoperable and metastatic squamous cell carcinoma of head and neck region |