| CTRI Number |
CTRI/2015/08/006080 [Registered on: 06/08/2015] Trial Registered Retrospectively |
| Last Modified On: |
05/08/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pilot Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study response rate after chemotherapy in inoperable of head and neck cancers. |
|
Scientific Title of Study
|
Open label, non controlled, non randomized, interventional pilot study to evaluate the response rate after induction therapy with Docetaxel (T) and cisplatin (P) in unresectable locally advanced squamous cell carcinoma of head and neck. |
| Trial Acronym |
Direct Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project Number 851 Version 1 Dated 1st May 2010 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kumar Prabhash |
| Designation |
Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
11th Floor,Homi Bhabha Block Tata Memorial Hospital
Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400 012
India |
| Phone |
022241777214 |
| Fax |
02224146392 |
| Email |
kprabhash1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumar Prabhash |
| Designation |
Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
11th Floor,Homi Bhabha Block Tata Memorial Hospital
Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400 012
India |
| Phone |
022241777214 |
| Fax |
02224146392 |
| Email |
kprabhash1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumar Prabhash |
| Designation |
Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
11th Floor,Homi Bhabha Block Tata Memorial Hospital
Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400 012
India |
| Phone |
022241777214 |
| Fax |
02224146392 |
| Email |
kprabhash1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aventis Pharma Limited |
| Address |
54/A, Sir Mathuradas Vasanji Road,
Andheri East,
Mumbai 400 093
India
Board Tel.: (91-22) 28278000
Fax: (91-22) 28370939 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Kumar Prabhash |
Tata Memorial Hospital |
Dr. E. Borges Road, Parel, Mumbai - 400 012 India
Mumbai
MAHARASHTRA |
022-24177000
kprabhash1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with histologically confirmed, unresectable locally advanced SCCHN of oral cavity, oropharynx, larynx or hypopharynx in stage III–IV without evidence of distant metastases
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Docetaxel & Cisplatin |
3 weekly and 3 cycles docetaxle 75mg/m2 in 500ml NS over 1hour and cisplatin 75mg/m2 in 500ml Ns over 1 hour intravenous. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(i) histologically confirmed, unresectable locally advanced SCCHN of oral cavity, oropharynx, larynx or hypopharynx in stage III–IV without evidence of distant metastases
(ii) no prior chemotherapy or radiation therapy;
(iii) having at least one measurable lesion in one dimension;
(iv) age >18 & <65 years with Eastern Cooperative Oncology Group (ECOG) < 1;
(v) adequate haematological function with neutrophil count P1500/ml, platelets >100,000/ml and haemoglobin >10 g/ml;
(vi) adequate hepatic function with bilirubin <1• the upper normal limit, GOT and GPT 62.5 the upper normal limit and alkaline phosphatase 65 5 times the upper normal limitthe upper normal limit;
(vii) renal function within normality with serum creatinine <1.4 mg/dl and creatinine clearance >60 ml/ min calculated by the Cockcroft–Gault method.
|
|
| ExclusionCriteria |
| Details |
(i) Peripheral neuropathy or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction 6 months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer)
(ii) Being treated concomitantly with corticosteroids (except as pre-medication)
(iii) Patients having another type of neoplasm.
(iv) Previous chemotherapy or radiotherapy
(v) Any previous definitive surgery for squamous cell carcinoma of head and neck
(vi) Severe weight loss (> 20 % of body weight) in the preceding 3 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the overall response (OR) rate (including CR and partial response (PR)) of subjects treated with induction regimen Docetaxel and cisplatin with locally advanced head and neck cancer.
|
Response after Neoadjuvant Chemotherapy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of induction regimen Docetaxel and cisplatin in patients with locally advanced head and neck cancer. |
safety profile at every cycle |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/06/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an interventional
study to assess the overall response rate of the patient treated with induction
regimen prior to chemo radiotherapy in patients with locally advanced head and
neck cancer. Patients will be treated with induction regimen followed by chemo
radiotherapy will be included in the study. The treatment regimen is as
follows: Induction Regimen: Patients to receive a 1-hour intravenous
infusion of Docetaxel at 75 mg/m2 followed by a 30-minute intravenous infusion
of cisplatin at 75 mg/m2. All patients to be premedicated oral dexamethasone at
8 mg twice daily for 3 days, commencing 1 day before Docetaxel infusion. All patients will be premedicated with Intravenous
dexamethasone at 20 mg and either ondansetron or granisetron to be administered
before cisplatin infusion. Cisplatin to be mixed with normal saline and
given with pretreatment and post treatment intravenous hydration and mannitol
diuresis. Either oral ondansetron 8 mg three times daily for 2 days or oral
metoclopramide 0.5 mg/kg four times daily for 2 days to be given, commencing 16
hours after cisplatin. Docetaxel and cisplatin treatments to be repeated every
21 days for 3 cycles, provided that the patient’s blood count had returned to normal (absolute
neutrophil count > 1500/mm3 ; platelet count > 100,000/µl) by the start of the
next scheduled chemotherapy cycle.
CRT:
Intravenous cisplatin to be administered at a
dose of 30 mg/m2 weekly starting concomitantly with conventional radiotherapy
to the primary tumor and to the clinically positive nodes. Intravenous
cisplatin to be continued till the radiotherapy continues
Radiotherapy treatment plan:
Planning target volumes
(PTVs) of the primary tumor, lymphnode metastases, lymphnodes at risk of
metastatic disease, critical organs and the major salivary glands will be
outlined on planning CT scan /MRI . Conformal and / or IMRT techniques will be
utilized. Gross disease PTV dose will be 66 Gy/30 fractions and sub clinical
PTV dose 60 – 54 Gy/30 fractions. The major salivary glands will be spare
according to specified criteria.
A boost of 4 – 6 Gy in2
-3 fractions to the gross tumor PTV is optional.
|