E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Squamous cell carcinoma of the head and neck [SCCHN]. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060121 |
E.1.2 | Term | Squamous cell carcinoma of head and neck |
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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 compare the 3-year survival achieved by Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck [SCCHN].
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E.2.2 | Secondary objectives of the trial |
1. To compare the 2-year progression free survival achieved by Docetaxel/Cisplatin/ 5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck [SCCHN].
2. To compare Survival at 5 years
3. To compare Progression Free Survival at 3 and 5 years
4. To compare the rate of complete response after all therapy
5. To determine and compare site-specific survival within and between each arm.
6. To compare functional organ preservation in each arm
7. To compare the toxicity of each treatment regimen
8. To compare quality of life
9. To establish tissue and germ line correlates of response, local regional control, and distant metastases in each arm.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically or cytologically proven squamous cell carcinoma of the head and neck.
2. Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. Oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection. Subjects with unknown primary sites will not be eligible for this study.
3. Stage 3 or 4 disease without evidence of distant metastases verified by chest X-Ray, abdominal ultrasound, PET/CT or CAT scan (liver function test abnormalities); bone scan in case of local symptoms.
4. At least one uni- or bidimensionally measurable lesion
5. No previous chemotherapy for any reason and no previous surgery for SCCHN (other than biopsy) are allowed at time of study entry (Prior tonsillectomy is allowed). No radiotherapy to the head and neck area is allowed. Patient who had radiotherapy for other cancers more than 5 years ago may be potential candidates for this trial; however each case must be discussed with the Overall PI, Dr. Robert Haddad.
6. Age > 18 years.
7. WHO performance status of 0 or 1
8. No active alcohol addiction that will interfere with participation in this study, as documented by the caregiver.
9. Signed informed consent prior to beginning protocol specific procedures.
10. Adequate bone marrow, hepatic and renal functions
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E.4 | Principal exclusion criteria |
1. Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter.
2. Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years. Any prior treatment with chemotherapy is an exclusion criterion.
3. Symptomatic peripheral neuropathy > grade 2 by National Cancer Institute Common Toxicity Criteria (NCIC-CTC Version 3.0).
4. Symptomatic altered hearing > grade 2 by NCIC-CTC v3.0 criteria.
5. Other serious illnesses or medical conditions including but not limited to:
• Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry • History of significant neurologic or psychiatric disorders including dementia or seizures. • Active clinically significant uncontrolled infection. • Active peptic ulcer disease defined as unhealed or clinically active and clinically significant, as documented by the investigator. • Clinically significant hypercalcemia. • Active drug addiction including cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis, which may interfere with study treatment, as documented by investigator. • Chronic Obstructive Pulmonary Disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis. This does not include obstruction from tumor. • Autoimmune disease requiring therapy, prior organ transplant, or HIV infection
6. Patients who experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry.
7. Concurrent treatment with any other anticancer therapy.
8. Participation in an investigational trial within 30 days of study entry.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is to compare the 3-year survival achieved by Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced SCCHN.
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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Provided in the study protocol. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |