Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
NCT ID:
NCT01772706
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 75 years
2. Patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage III-IV, histologically confirmed
3. PS \> or = 2
4. Estimated life expectancy greater than 3 months in the absence of treatment
5. Concomitant chemotherapy with one of the following choices not prohibited:
* Cetuximab alone
* 5-FU combined to Carboplatin or Cisplatin
* Cisplatin alone Being defined as follows: serum creatinine \< 150 µmol/l and creatinine clearance superior or equal to 55ml/min (calculated with the Cockcroft method) in case of serum creatinine \> 120 µmol/l
6. Appropriate hematological, renal and hepatic function parameters, within 15 days prior to randomization, with the following results:
* Hemoglobin\> 8g/dL
* Neutrophils\> 1500 x 109 / L
* Platelets\> 100 x 109 / l
* Total bilirubin \<1.5 times the upper limit of normal
* ALT / AST and alkaline phosphatase \<2.5 times the upper limit of normal.
7. For women of childbearing potential, a reliable contraceptive measure (hormonal contraception, intrauterine device) is required.
Exclusion Criteria:
1. Presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix
2. Neoadjuvant chemotherapy
3. Metastatic disease
4. Previous treatment with ENT radiotherapy
5. Severe hypersensitivity known to platinum based agent
6. Any uncontrolled pathology (respiratory, cardiac, hepatic or renal)
7. Pregnant or breastfeeding women (a seric or urinary pregnancy test must be negative at the time of study entry for women of childbearing age).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01772706
Study Brief:
Protocol Section:
NCT01772706