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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001211-33 | EudraCT Number |
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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:
Planned treatment duration:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel/Cisplatin/5-FU (TCF) | Experimental |
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
|
| Cisplatin/5-FU (CF) | Active Comparator |
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | Pharmaceutical form:solution for infusion Route of administration:intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response (CR) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 012001 | Algiers | 16005 | Algeria | |||
| Investigational Site Number 076002 |
Not provided
Participants were enrolled from November 2007 until October 2008. The study was conducted at 26 centers in 14 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel /Cisplatin/5-FU | Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy. Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| cisplatin | Drug | Pharmaceutical form:solution for infusion Route of administration:intravenous |
|
| 5-fluorouracil | Drug | Pharmaceutical form:solution for infusion Route of administration:intravenous |
|
|
| Overall Response (OR) | 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 | 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) |
| Rio de Janeiro |
| 20230-130 |
| Brazil |
| Investigational Site Number 076001 | São Paulo | 04023-062 | Brazil |
| Investigational Site Number 156005 | Fuzhou | 350014 | China |
| Investigational Site Number 250001 | Villejuif | 94805 | France |
| Investigational Site Number 356003 | Ahmedabad | 380006 | India |
| Investigational Site Number 356004 | Kolkata | 700054 | India |
| Investigational Site Number 356002 | Thiruvananthapuram | 695011 | India |
| Investigational Site Number 356001 | Vellore | 632004 | India |
| Investigational Site Number 360001 | Jakarta | 10430 | Indonesia |
| Investigational Site Number 380001 | Milan | 20133 | Italy |
| Investigational Site Number 484001 | Villahermosa | 86100 | Mexico |
| Investigational Site Number 504001 | Casablanca | 20000 | Morocco |
| Investigational Site Number 504002 | Rabat | 10000 | Morocco |
| Investigational Site Number 504003 | Rabat | Morocco |
| Investigational Site Number 608002 | Quezon City | Philippines |
| Investigational Site Number 410001 | Seoul | 110-744 | South Korea |
| Investigational Site Number 410003 | Seoul | 135-710 | South Korea |
| Investigational Site Number 410002 | Seoul | 138-736 | South Korea |
| Investigational Site Number 764001 | Bangkok | 10330 | Thailand |
| Investigational Site Number 764002 | Chiang Mai | 50200 | Thailand |
| Investigational Site Number 788002 | Sousse | 4000 | Tunisia |
| Investigational Site Number 788003 | Tunis | 1006 | Tunisia |
| Investigational Site Number 792003 | Abacıoğlu | 34662 | Turkey (Türkiye) |
| Investigational Site Number 792001 | Ankara | 06100 | Turkey (Türkiye) |
| Investigational Site Number 792002 | Istanbul | 34303 | Turkey (Türkiye) |
| Cisplatin/5-FU |
Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy. Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
ITT population: all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel /Cisplatin/5-FU | Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy. Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
| BG001 | Cisplatin/5-FU | Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy. Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Complete Response (CR) | 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. | ITT population: all randomized participants. | Posted | Number | participants | after the completion of the induction treatment (up to 9 weeks) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group | 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). | Participants who were randomized to docetaxel/cisplatin/5-FU and had evaluable docetaxel pharmacokinetic (PK) sample. | Posted | Mean | Standard Deviation | µg*h/mL | Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response (OR) | 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. | ITT population: all randomized participants. | Posted | Number | participants | after the completion of the consolidation treatment (up to 18 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Rate | 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. | ITT population: all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years after the end of the consolidation treatment period (up to 40 months from randomization) |
|
|
All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on treatment period' (from first dose up 30 days after administration of the last cycle [maximum 3 cycle]). Safety population: all subjects who received at least one cycle of any component of the study drug combination.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cisplatin/5-FU | Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy. Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. | 11 | 25 | 23 | 25 | ||
| EG001 | Docetaxel /Cisplatin/5-FU | Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy. Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. | 20 | 50 | 49 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BONE MARROW FAILURE | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| NEUTROPENIA/NEUTROPHIL COUNT | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDra | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| MALLORY-WEISS SYNDROME | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| PROCTALGIA | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDra | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDra | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDra | Systematic Assessment |
| |
| CENTRAL LINE INFECTION | Infections and infestations | MedDra | Systematic Assessment |
| |
| NEUTROPENIC INFECTION | Infections and infestations | MedDra | Systematic Assessment |
| |
| PHARYNGITIS BACTERIAL | Infections and infestations | MedDra | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDra | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDra | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDra | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDra | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDra | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDra | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDra | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDra | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDra | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDra | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDra | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDra | Systematic Assessment |
| |
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDra | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDra | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDra | Systematic Assessment |
| |
| ACUTE PRERENAL FAILURE | Renal and urinary disorders | MedDra | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDra | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| BONE MARROW FAILURE | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| NEUTROPENIA/NEUTROPHIL COUNT | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDra | Systematic Assessment |
| |
| OTOTOXICITY | Ear and labyrinth disorders | MedDra | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| ODYNOPHAGIA | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| SALIVARY HYPERSECRETION | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDra | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDra | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDra | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDra | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDra | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDra | Systematic Assessment |
| |
| FOLLICULITIS | Infections and infestations | MedDra | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDra | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDra | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDra | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDra | Systematic Assessment |
| |
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDra | Systematic Assessment |
| |
| THERMAL BURN | Injury, poisoning and procedural complications | MedDra | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDra | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDra | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDra | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDra | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDra | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDra | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDra | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDra | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDra | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDra | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDra | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDra | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDra | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDra | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDra | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDra | Systematic Assessment |
| |
| NEPHROPATHY TOXIC | Renal and urinary disorders | MedDra | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDra | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDra | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDra | Systematic Assessment |
| |
| PHARYNGEAL INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDra | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDra | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDra | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDra | Systematic Assessment |
| |
| SKIN HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | MedDra | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDra | Systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | sanofi | Contact-us@sanofi.com |
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| D002277 | Carcinoma |
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Children from 2 years to <12 years |
|
| Adolescents from 12 years to <16 years |
|
| Adolescents >=16 |
|
| Male |
|
|
|
|
|