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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. 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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included rampukarbharat@gmail.com).

  6. 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.

  7. 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.
 
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