- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00565448
Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
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
The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC).
The secondary objectives are to determine:
- the safety of TCF in comparison to CF after induction treatment of NPC,
- the pharmacokinetics of docetaxel when added to CF,
- the Overall Response rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and CF.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Planned treatment duration:
- induction period: 9 weeks of induction treatment
- consolidation period: 9 weeks of chemoradiation treatment.
The consolidation treatment was the same for all participants: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Alger, Algeria, 16005
- Investigational Site Number 012001
-
-
-
-
-
Rio De Janeiro, Brazil, 20230-130
- Investigational Site Number 076002
-
Sao Paulo, Brazil, 04023-062
- Investigational Site Number 076001
-
-
-
-
-
Fuzhou, China, 350014
- Investigational Site Number 156005
-
-
-
-
-
Villejuif Cedex, France, 94805
- Investigational Site Number 250001
-
-
-
-
-
Ahmedabad, India, 380006
- Investigational Site Number 356003
-
Kolkata, India, 700054
- Investigational Site Number 356004
-
Thiruvananthapuram, India, 695011
- Investigational Site Number 356002
-
Vellore, India, 632004
- Investigational Site Number 356001
-
-
-
-
-
Jakarta, Indonesia, 10430
- Investigational Site Number 360001
-
-
-
-
-
Milano, Italy, 20133
- Investigational Site Number 380001
-
-
-
-
-
Seoul, Korea, Republic of, 135-710
- Investigational Site Number 410003
-
Seoul, Korea, Republic of, 138-736
- Investigational Site Number 410002
-
Seoul, Korea, Republic of, 110-744
- Investigational Site Number 410001
-
-
-
-
-
Villahermosa, Mexico, 86100
- Investigational Site Number 484001
-
-
-
-
-
Casablanca, Morocco, 20000
- Investigational Site Number 504001
-
Rabat, Morocco, 10000
- Investigational Site Number 504002
-
Rabat, Morocco
- Investigational Site Number 504003
-
-
-
-
-
Quezon City, Philippines
- Investigational Site Number 608002
-
-
-
-
-
Bangkok, Thailand, 10330
- Investigational Site Number 764001
-
Chiang Mai, Thailand, 50200
- Investigational Site Number 764002
-
-
-
-
-
Sousse, Tunisia, 4000
- Investigational Site Number 788002
-
Tunis, Tunisia, 1006
- Investigational Site Number 788003
-
-
-
-
-
Abacioglu, Turkey, 34662
- Investigational Site Number 792003
-
Ankara, Turkey, 06100
- Investigational Site Number 792001
-
Istanbul, Turkey, 34303
- Investigational Site Number 792002
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histological diagnosis of nasopharyngeal carcinoma World Health Organization (WHO) type II or III
- Children and adolescents newly diagnosed with Stage IIB-IV NPC with measurable disease, who are >1 month to ≤21 years of age at the time of diagnosis. In France, participants must be ≥1 year to ≤21 years of age at the time of diagnosis
Exclusion Criteria:
- Participants with short life expectancy
- Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
- Inadequate renal function evidenced by unacceptable laboratory results
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Docetaxel/Cisplatin/5-FU (TCF)
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
Pharmaceutical form:solution for infusion Route of administration:intravenous
Other Names:
Pharmaceutical form:solution for infusion Route of administration:intravenous Pharmaceutical form:solution for infusion Route of administration:intravenous
Other Names:
|
Active Comparator: Cisplatin/5-FU (CF)
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
Pharmaceutical form:solution for infusion Route of administration:intravenous Pharmaceutical form:solution for infusion Route of administration:intravenous
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Complete Response (CR)
Time Frame: after the completion of the induction treatment (up to 9 weeks)
|
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI).
Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment.
CR defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
|
after the completion of the induction treatment (up to 9 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group
Time Frame: Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion
|
AUC estimated by Bayesian method using concentration-time data for each participant and the previously defined adult population model as prior information (with validity of the estimation verified).
|
Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion
|
Overall Response (OR)
Time Frame: after the completion of the consolidation treatment (up to 18 weeks)
|
OR is classified as CR, partial response (PR), stable disease (SD), progressive disease (PD) or Unknown on completion of both induction and radiation treatment and assessed according to the Modified RECIST from the NCI.
CR is defined as the disappearance of all target lesions (TLs) and non-TLs.
PR is defined as ≥30% decrease in the sum of the longest diameters (LD) of TLs, taking as reference the disease measurement done at study entry.
PD is defined as ≥20% increase in the sum of the LD of TLs, taking as a reference the smallest disease measurement recorded at study entry or the appearance of ≥1 new lesions or unequivocal progression of non-TLs.
SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
|
after the completion of the consolidation treatment (up to 18 weeks)
|
Overall Survival (OS) Rate
Time Frame: 3 years after the end of the consolidation treatment period (up to 40 months from randomization)
|
OS rate is the percentage of participants who survived 3 years after completion of consolidation treatment period.
The Kaplan-Meier method was used to estimate OS rate.
|
3 years after the end of the consolidation treatment period (up to 40 months from randomization)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Carcinoma
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Fluorouracil
Other Study ID Numbers
- EFC10339
- 2007-001211-33 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingEstrogen Receptor Positive | Ductal Breast Carcinoma In Situ | Grade 1 Invasive Breast Carcinoma | Grade 2 Invasive Breast Carcinoma | Grade 3 Invasive Breast Carcinoma | Invasive Ductal and Lobular Carcinoma In Situ | Mucinous Breast Carcinoma | Tubular Breast CarcinomaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Locally Advanced Bladder Urothelial Carcinoma | Locally Advanced Renal Pelvis Urothelial... and other conditionsUnited States
-
National Cancer Institute (NCI)Not yet recruitingBreast Carcinoma | Breast Ductal Carcinoma In Situ | Breast Lobular Carcinoma In Situ | Estrogen Receptor-Positive Breast CarcinomaUnited States
-
Eye & ENT Hospital of Fudan UniversityChanghai Hospital; Fudan University; RenJi Hospital; Xinhua Hospital, Shanghai... and other collaboratorsRecruitingGlottic Carcinoma | Supraglottic Carcinoma | Subglottic Carcinoma | Pyriform Sinus Carcinoma | Postcricoid Carcinoma | Posterior Pharyngeal Wall CarcinomaChina
-
Mamta ParikhNational Cancer Institute (NCI); Karyopharm Therapeutics IncRecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Advanced Urothelial Carcinoma | Refractory Urothelial CarcinomaUnited States
-
Ohio State University Comprehensive Cancer CenterEmbr Labs, Inc.Active, not recruitingHot Flashes | Breast Carcinoma | Breast Ductal Carcinoma In Situ | Breast Lobular Carcinoma In SituUnited States
-
Institut BergoniéCompletedIntraductal Carcinoma and Lobular Carcinoma in SituFrance
-
University of UtahNational Cancer Institute (NCI)RecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Unresectable Urothelial Carcinoma | Infiltrating Urothelial Carcinoma, Sarcomatoid VariantUnited States
-
Roswell Park Cancer InstituteIovance Biotherapeutics, Inc.WithdrawnMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Unresectable Renal Pelvis Urothelial Carcinoma | Unresectable Ureter Urothelial CarcinomaUnited States
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedAdvanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular Carcinoma | Stage III... and other conditionsUnited States
Clinical Trials on docetaxel
-
Nereus Pharmaceuticals, Inc.CompletedCancerUnited States, Australia, India, Chile, Brazil, Argentina
-
Tianjin Medical University Cancer Institute and...Recruiting
-
National Cancer Center, KoreaSeoul National University Bundang Hospital; Gachon University Gil Medical Center and other collaboratorsUnknownGastric CancerKorea, Republic of
-
Zhuhai Beihai Biotech Co., LtdCompletedSolid Tumours | Bioequivalence | DocetaxelIndia
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaCompletedNon-Small Cell Lung Cancer (NSCLC)China
-
Optimal Health ResearchCompletedBreast Cancer | Lung Cancer | Prostate CancerUnited States
-
Arog Pharmaceuticals, Inc.WithdrawnCarcinoma, Non-Small-Cell Lung
-
Boehringer IngelheimCompletedCarcinoma, Non-Small-Cell LungJapan
-
SanofiCompletedLung NeoplasmsFrance, Netherlands, Spain, Turkey, Belgium, Finland, Italy, United Kingdom
-
SanofiCompleted