| CTRI Number |
CTRI/2017/05/008700 [Registered on: 30/05/2017] Trial Registered Prospectively |
| Last Modified On: |
17/05/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Docetaxel chemotherapy with radiation in head and neck cancer |
|
Scientific Title of Study
|
DHANUSH : Docetaxel as radiosensitizer in Head And Neck cancer patients,Unsuitable for ciSplatin based cHemoradiation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Patil |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1110, 11th floor, Homi Bhabha Block, Tata Memorial
Hospital, Dr E Borges Marg, Parel, East
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
vijaypgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Patil |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1110, 11th floor, Homi Bhabha Block, Tata Memorial
Hospital, Dr E Borges Marg,Parel,East
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
vijaypgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Patil |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1110, 11th floor, Homi Bhabha Block ,Tata Memorial
Hospital, Dr E Borges Marg, Parel, East
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
vijaypgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre
Dr E Borges Marg
Parel East |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital 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
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVijay Patil |
Tata Memorial Hospital |
OPD No 204 2nd Floor Homi Bhabha Block Medical Oncology Department Tata Memorial Hospital Dr E Borges marg Parel Mumbai 400012
Mumbai
MAHARASHTRA |
022-24177000
vijaypgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having head and neck cancers who are unsuitable for cisplatin based chemoradiation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Radical or Adjuvant Radiation |
Radical ( 70 Gy over 7 weeks) or Adjuvant Radiation ( 60 Gy over 6 weeks) without chemotherapy |
| Intervention |
Radical or Adjuvant radiation with chemotherapy |
Radical ( 70 Gy over 7 weeks) or Adjuvant Radiation ( 60 Gy over 6 weeks) with chemothearpy weekly docetaxel 15 mg/m2 maximum 7 cycles intravenous with low antiemetic prophylaxis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants must have a histologically confirmed stage III-IV squamous cell cancers of the head and neck region.
2. Participants must warrant CTRT must warrant at least one of the following
a. Radical setting : stage III-IV head and neck cancer
b. Adjuvant setting : Stage III-IV head and neck cancer postoperative with one of the below mentioned feature on pathology specimen
i. Extracapsular extension
ii. Margin positive
iii. Close margin ( cut margin 0.5 mm or below)
3. 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
4. Unsuitable for cisplatin due to at least anyone of the following reason
a. Performance status ECOG (Eastern Cooperative Oncology Group) score of grade 2
b. Organ dysfunction of grade 2 or higher based on the NCI CTC (National Cancer Institute Common Toxicity Criteria) version 4.0 , such as hearing loss and tinnitus and neurologic disorders
c. Hypersensitivity to Cisplatin
d. Calculated creatinine clearance (CCR) value of <50 ml/min
e. Borderline organ function or comorbidities precluding use of cisplatin
f. Weight loss : > 10% of baseline body weight in preceding 6 months
g. Nutritional status : Malnourished status as defined by BMI 16 KG/m2
h. Concomitant use of nephrotoxic drugs required for concurrent medical condition
5. Age : Any age above 18 years. No maximum age.
6. ECOG performance status ≤2
7. Participants must have normal organ and marrow function as defined below:
a. Leukocytes ≥3,000/mcL
b. Platelets ≥100,000/mcL
c. Total bilirubin < 1.5 × institutional upper limit of normal
d. AST(SGOT)/ALT(SGPT) ≤1.5 × institutional upper limit of normal
e. Calculated Creatinine clearance > 30 ml/min
8. The effects of docetaxel 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 6 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. Participants who are receiving any other investigational agents.
2. Primary sites of malignancy major salivary gland or nasopharynx or skin
3. Patients with QTc prolongation defined as QTc interval greater than 480 ms in view of risk of sudden cardiac death associated with use of antiemetics.
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
5. Uncontrolled intercurrent illness including, but not limited to tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease, known hyperkalemia ( CTCAE version 4.02 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements.
6. Pregnant women and breastfeeding women are excluded from this study because docetaxel has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants. These potential risks may also apply to other agents used in this study.
7. HIV-positive, Active Hepatitis B and Active Hepatitis C seropositive patients are excluded from this study.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Overall survival
|
1. 2 Years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Disease Free survival
2.Quality of life
3.Toxicity |
1.2 Years
2.At baseline, 6 months, 12 months and at 24 months
3.Between the 2 arms during any period of chemotherapy |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
14/06/2017 |
| 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="12"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Chemoradiation (CTRT) with cisplatin is the standard of care in locally advanced head and neck cancers. However in clinical practice about about 10-20% of patients are unfit for cisplatin. At present these patients are treated with radical radiation or docetaxel based CTRT or RT ( radiation) with cetuximab on physician s discretion and logistic feasibility. Recent meta analysis have suggested that taxane based chemoradiation might be superior to only RT in head and neck cancers. However whether docetaxel based chemoradiation can provide similar benefit in patients who are unfit for cisplatin as provided by cisplatin based CTRT over radiation is unknown.
It is Phase 2 going to Phase 3 randomized, parallel, open label, superiority , explanatory design.
Patients will be randomized on Arm A and Arm B. Arm A : Radical radiation ( conventional or altered fractionation) Arm B : Radical radiation ( conventional or altered fractionation) + weekly docetaxel ( 15 mg/m2 for maximum of 7 cycles)
Outcomes will be 2years OS,2 Years PFS,Toxicity and Trial Outcome Index. |