| CTRI Number |
CTRI/2024/10/075166 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of two neoadjuvant chemotherapy drug regimens in technically unresectable head and neck cancer. |
|
Scientific Title of Study
|
A prospective comparative analysis of two neoadjuvant chemotherapy protocols in technically unresectable head and neck cancer. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ram Pukar Bharat |
| Designation |
Senior Resident (Acad) |
| Affiliation |
Jawaharlal Nehru Medical College(Sawangi,) Wardha , Maharashtra |
| Address |
Department of Medical Oncology, Jawaharlal Nehru Medical College(Sawangi,) Wardha , Maharashtra
Wardha MAHARASHTRA 442001 India |
| Phone |
9386950771 |
| Fax |
|
| Email |
rampukarbharat@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Amol Shankar Dongre |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College(Sawangi,) Wardha , Maharashtra |
| Address |
Department of Medical Oncology, Jawaharlal Nehru Medical College(Sawangi,) Wardha , Maharashtra
Wardha MAHARASHTRA 442001 India |
| Phone |
9386950771 |
| Fax |
|
| Email |
amolpgi@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Ram Pukar Bharat |
| Designation |
Senior Resident (Acad) |
| Affiliation |
Jawaharlal Nehru Medical College(Sawangi,) Wardha , Maharashtra |
| Address |
Department of Medical Oncology, Jawaharlal Nehru Medical College(Sawangi,) Wardha , Maharashtra
Wardha MAHARASHTRA 442001 India |
| Phone |
9386950771 |
| Fax |
|
| Email |
rampukarbharat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College Sawangi Wardha and Acharya Vinoba Bhave rural Hospital,Sawangi, Wardha, Pin code- 442001, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital Sawangi Wardha |
| Address |
Jawaharlal Nehru Medical College Sawangi Wardha,Pin code- 442001, Maharashtra, India |
| Type of Sponsor |
Private 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 Ram Pukar Bharat |
Jawaharlal Nehru Medical College (Sawangi )Wardha |
Room no 47
Ward no-47
1st floor
Division- Siddharth Gupta Memorial Cancer Hospital
Department of Medical Oncology Wardha MAHARASHTRA |
9386950771
bharatkumar1271985@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| D.M.I.H.E.R. (D.U.) INSTITUTIONAL ETHICS COMMITTEE |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ARM A - NEOADJUVANT CHEMOTHERAPY REGIMEN
1. Inj. PACLITAXEL
2. Inj. CISPLATIN
3. inj. 5 FLURO-URACIL (5FU) |
ON WEEKLY BASIS FOR 9 CYCLES:-
1. Inj. PACLITAXEL
DOSE- 100 mg IV infusion on DAY 01, WEEKLY FOR 9 CYCLES
2. Inj. CISPLATIN
DOSE- 50 mg IV infusion on
DAY 01 , WEEKLY FOR 9 CYCLES
3. Inj. 5 FLURO URACIL( FU )
DOSE- 500 mg/m2 IV infusion over 6 HOUR on DAY-01, WEEKLY FOR 9 CYCLES
|
| Comparator Agent |
ARM B -
NEOADJUVANT CHEMOTHERAPY "ORAL METRONOMIC CHEMOTHERAPY",OMCT
1. TAB GEFITINIB 250MG
2. TAB CELECOXIB 200MG
3. TAB METHOTREXATE 15MG/M2 |
ON MONTHLY BASIS FOR 3 CYCLES:-
1. TAB GEFITINIB 250MG
DOSE- 1TAB PO DAILY FOR 3 MONTHS
2. TAB CELECOXIB 200MG
DOSE- PO 1TAB TWICE DAILY FOR 3 MONTHS
3. TAB METHOTREXATE 15MG/M2
DOSE-15MG/M2(TOTAL DOSE CALCULATED AS PER SURFACE BODY AREA) 1TAB PO ONCE WEEKLY FOR 3 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a. Age between 18 - 75 yrs.
b. ECOG performance status (ECOG PS): ≥3
c. Biopsy proven of Head and Neck region
d. Carcinoma Head & Neck staged IVA – IVB of all sub-sites namely Oral Cavity / Oropharynx / Hypo-pharynx /Larynx / Nasopharyngeal / Para-nasal sinus and Salivary gland primary.
e. Technically unresectable head and neck cancer in view of local invasion.
f. No synchronous / metachronous malignancy.
g. No prior cancer directed Treatment.
h. Giving written informed consent. |
|
| ExclusionCriteria |
| Details |
a. ECOG performance status (ECOG PS)
b. Any prior oncologic treatment with surgery, chemotherapy or radiotherapy.
c. Any co-morbidity which compromises treatment schedules e.g. Severe cardio-respiratory disease, renal-disease etc.
d. Patients refusing to give written informed consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Compare proportion of patients eligible for radical treatment.
2. Assess loco-regional disease control at 3 and 6 months. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assess and compare the degree of symptom relief and palliation
2. To compare toxicity between arms |
18 months |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
25/10/2024 |
| 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)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included rampukarbharat@gmail.com).
- For how long will this data be available start date provided 25-10-2024 and end date provided 10-10-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL. NO POLICY FOR SHARING IPD .
|
|
Brief Summary
|
In India, nearly two-thirds of patients of head and neck cancers present in advanced stages . The majority (60%) of these patients present with stage III/IV and have a poor-prognosis disease. The patients usually present in their fifth and early sixth decades of life in Asian population compared to seventh and eighth decades among Western population. Advanced head and neck cancers carry a dismal prognosis and patients usually die of uncontrolled loco-regional disease or its complications. Locally advanced oral cavity cancers with features discussed below are considered technically unresectable and selected for neoadjuvant (1) Buccal mucosa primary, with diffuse margins and peritumoral oedema going up to or above the level of zygomatic arch and without any satellite nodules. 2. Tongue primary {anterior 2/3rds} with the tumour extending up to or below the level of the hyoid bone. 3. Extension of tumour of anterior two third of oral tongue to the vallecula. 4. Extension of tumour into the high infratemporal fossa, as defined by the extension of tumour above an axial plane passing at the level of the sigmoid notch. 5. Extensive skin infiltration impacting the achievement of negative margins. Treatment decisions for locally advanced HNSCC, include the delivery of single versus multiple modality therapy. The sequence of administration if multi- modality therapy is indicated is based upon several factors that can be tumor-related, such as primary site and stage, as well as patient-related characteristics, such as age, performance status and pre-existent co-morbidities. TAX 323 and 324 are regarded as landmark studies that have used neoadjuvant chemotherapy in locally advanced HNC. The response rates with the three-drug regime were to the tune of 68%; however oral cavity cancers constituted a minority of the treated patient population in these studies. Results from early trials and encouraging results from meta-analyses have revived interest in the use of neoadjuvant chemotherapy prior to definitive local treatment. Based on the initial reports of the GORTEC2000-1, TAX323 and TAX324 trials, neoadjuvant chemotherapy followed by either RT or CRT is frequently used for the treatment of curable LAHNC and TPF has been approved by the Federal Drug Administration (FDA) for the treatment of LAHNC. Nonetheless, the role of neoadjuvant chemotherapy is still poorly defined and randomized trials are under way to determine whether induction chemotherapy is superior to concomitant chemo/RT. In this study we will compare two neoadjuvant chemotherapy in technically unresectable head and neck cancer. |