| CTRI Number |
CTRI/2008/091/000007 [Registered on: 25/01/2008] |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
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Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
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A clinical trial to study the effect of Docetaxel when added to standard treatment (Cisplatin and 5-FluroUracil) in Nasopharyngeal Carcinoma in children and adolescents. |
Scientific Title of Study
Modification(s)
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International randomized study to evaluate the addition of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) vs. cisplatin-5-fluorouracil (CF) in the induction treatment of nasopharyngeal carcinoma (NPC) in children and adolescents. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| EFC10339 |
Protocol Number |
| NCT00565448 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Mrs Gayatri Jaiswal |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo India Limited |
| Address |
Aventis house, 54/A, Sir Mathuradas Vasanji Road, Andheri (E)
Andheri (E)
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02230707806 |
| Fax |
02230707843 |
| Email |
Gayatri.Jaiswal@sanofi-aventis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mrs Gayatri Jaiswal |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo India Limited |
| Address |
Aventis house, 54/A, Sir Mathuradas Vasanji Road
Andheri (E)
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02230707806 |
| Fax |
022307078434 |
| Email |
Gayatri.Jaiswal@sanofi.com |
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Source of Monetary or Material Support
Modification(s)
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| Group sanofi-aventis,
Aventis house, 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai 400093, |
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Primary Sponsor
Modification(s)
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| Name |
Sanofi Synthelabo India Limited |
| Address |
54/A, Sir Mathuradas Vasanji Road,
Andheri (East)
Mumbai – 400 093
India
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| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
Modification(s)
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|
Countries of Recruitment
Modification(s)
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India
Indonesia
Thailand
Morocco
South Africa
Turkey |
Sites of Study
Modification(s)
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| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subhashini John |
Christian Medical College |
(Main Campus), Department of Radiotherapy,
Vellore 632 004,
Tamil Nadu, INDIA
Vellore
TAMIL NADU |
04162282046
subha@cmcvellore.ac.in |
| Dr Gauri Shankar Bhattacharyya |
Orchid Nursing Home |
P-17, CIT Road,Scheme VI M Phoolbagan, Kolkata 700054
Kolkata
WEST BENGAL |
03323202729
docgs@hotmail.com |
| Dr Ranga Rao |
Rajiv Gandhi Cancer Institute and Research Centre |
Rajiv Gandhi Cancer Institute and Research Centre, Sector V, Rohini, Delhi 110085
New Delhi
DELHI |
01147022222
ranga_rr@vsnl.net |
| Dr Rejnish Kumar |
Regional Cancer Center |
Division of Head & Neck Oncology,
Thiruvananthapuram - 695011
Kerala, INDIA
Thiruvananthapuram
KERALA |
04712522239
rejnish@yahoo.com |
| Dr Shailesh Talati |
The Gujarat Cancer & Research Institute |
Clinical Research Wing, Civil Hospital Campus, Asarwa, Ahmadabad-380 016, Gujarat, INDIA.
Ahmadabad
GUJARAT |
07922681451
gcri.clinicaltrials@gmail.com |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee of Christian Medical College / Vellore / Subhashini John |
Approved |
| Gujarat Cancer Research Institute /Gujarat Cancer Society Ethics Committee, Ahmedabad, Dr Shailesh Talati |
Approved |
| Human Ethics Committee, Regional Cancer Center / Thiruvananthapuram / Rejnish Kumar |
Approved |
| Institutional Ethical Review Board Orchid Nursing Home / Kolkata / Gauri Shankar Bhattacharyya |
Approved |
| Institutional Review Borad, Rajiv Gandhi Cancer Institute and Research Centre/ Delhi/Ranga Rao |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
Nasopharyngeal Carcinoma in children and adolescents., (1) ICD-10 Condition: C119||Malignant neoplasm of nasopharynx,unspecified, |
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Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Cisplatin |
75 mg/m2, Intravenous, over 6 hours, on Day 1, every 3 weeks (3 cycles) |
| Intervention |
Docetaxel |
75 mg/m2, Intravenous, on Day 1, every 3 weeks (3 cycles) |
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Inclusion Criteria
Modification(s)
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| Age From |
1.00 Month(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
1. Histological confirmed nasopharyngeal carcinoma, subtypes WHO type II (non-keratinizing carcinoma) or III (undifferentiated carcinoma including lymphoepitheliomas)
2. Newly diagnosed disease NPC Stage IIB-IV disease with measurable disease.
3. Ages eligible for study: >1 month to ≤21 years of age at time of diagnosis.
4. Genders eligible for study: Both
5. All patients and/or their parents or legal guardians must sign a written informed consent and assent.
|
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| ExclusionCriteria |
| Details |
1. Patients with short (less than 12 weeks) of life expectancy.
2. Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
3. Performance status:
− Patients ≤16 years of age: Lansky <60%
− Patients >16 years of age: Karnofsky <60%
4. Creatinine clearance or radioisotope glomerular filtration rate (GFR) <70 mL/min OR Serum creatinine based on age as follows for the calculation of GFR to :
− Greater than 0.8 mg/dL (for patients ≤5 years of age)
− Greater than 1.0 mg/dL (for patients 6-10 years of age)
− Greater than 1.2 mg/dL (for patients 11-15 years of age)
− Greater than 1.5 mg/dL (for patients >15 years of age)
5. Bilirubin >1.5 times upper limit of normal (ULN) for age
6. AST or ALT >2.5 times ULN for age
7. Hypersensitivity to one of the drugs or their excipients.
8. Pregnant or breast feeding females
9. Females of child bearing potential who are unwilling or unable to be tested for pregnancy
10. Females of child bearing potential who are unwilling or unable to use effective contraception
11. Refusal or inability to give informed consents to participate in the study
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Method of Generating Random Sequence
Modification(s)
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Computer generated randomization |
Method of Concealment
Modification(s)
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Centralized |
Blinding/Masking
Modification(s)
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Open Label |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
Primary end point:
Complete response (CR) rate following the Induction treatment and prior to the radiation treatment.
|
2 years |
|
Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
Secondary end points:
1. Overall safety and efficacy of docetaxel in combination with CF.
2. Overall response on completion of Radiotherapy treatment.
3. Role of EBV and the predictive value of the determination of EBV-DNA in peripheral blood.
4. Overall survival comparison between arms. |
3 years |
|
Target Sample Size
Modification(s)
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Total Sample Size="72"
Sample Size from India="5"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
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Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
22/04/2007 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/10/2007 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet available |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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Trial will be conducted in 16 countries all over the world The Indian target - 6 patients. Indian status - 5 patients randomized.
|