E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Children and adolescents newly diagnosed with NPC Stage IIB-IV with measurable disease, of >1 month to ≤21 years of age at the time of diagnosis. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028793 |
E.1.2 | Term | Nasopharyngeal carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- to estimate the Complete Response (CR) rate of TCF compared to CF in the Induction treatment of NPC.
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E.2.2 | Secondary objectives of the trial |
- to determine of the Safety of TCF in comparison to CF after induction treatment of NPC.
- to determine pharmacokinetics (PK) of docetaxel when added to CF
- to determine Overall Response (OR) rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC.
- to compare overall survival between TCF and CF. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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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E.4 | Principal exclusion criteria |
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 (Appendix C)
− 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 (13) OR
− Serum creatinine based on age as follows for the calculation of GFR:
• 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 (13)
6. AST or ALT > 2.5 times ULN for age (13)
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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E.5 End points |
E.5.1 | Primary end point(s) |
Complete response (CR) rate following the Induction treatment is the primary end point of the study. The assessment of CR will be performed according to the modified version of Response Evaluation Criteria in Solid Tumors (RECIST) [ie, combination of volumetric assessment (primary NPC, associated adenopathy) and for measurable and non-measurable metastatic foci as per RECIST] after the completion of the induction treatment (3 cycles) and prior to the radiation treatment. MRI is the best currently available and reproducible method to measure target lesions selected for response assessment. All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline. CR is defined as the disappearance of all target and non-target lesions. An Independent Committee will assess CR rate in this study.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
characterize the role of EBV in the pathogenesis of NPC |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Association Cisplatin and 5 Fluorouracil as the control arm |
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E.8.3 |
Will this trial be conducted at a single site globally?
| Information not present in EudraCT |
E.8.4 | Will this trial be conducted at multiple sites globally? | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
Algeria |
Brazil |
China |
India |
Indonesia |
Korea, Republic of |
Mexico |
Morocco |
Philippines |
Thailand |
Tunisia |
Turkey |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Follow Up period of 3 years |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |