A phase II clinical trial for patients with cancer of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls) that is non-smoking associated and is positive for the p16 biomarker.
- Conditions
- ocoregionally advanced oropharyngeal cancerMedDRA version: 19.0Level: PTClassification code 10031096Term: Oropharyngeal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002244-16-IE
- Lead Sponsor
- Irish Clinical Oncology Research Group CLG, trading as Cancer Trials Ireland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 296
> Step 1: Registration
1. Pathologically (histologically/cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma&basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation&should be sufficient to estimate the size of the primary (for T stage).
2. Clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving = 4 nodes are permitted&considered as non-therapeutic nodal excisions.
3. Immunohistochemical (IHC) staining for p16 must be performed on tissue&this tissue must be submitted for central review. Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block material is available for p16 IHC. FNA specimens prepared with adequate p16 testing in this manner are acceptable to submit for central review. If the p16 preparation is not adequate, additional specimens will be required to establish p16 status.
4. Clinical stage T1-T2, N1-N2b or T3, N0-N2b (AJCC, 7th ed.) including no distant metastases based on the following diagnostic workup:
? General history&physical examination within 56 days prior to registration;
? Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 70 days prior to registration;
? One of the following combinations of imaging is required within 56 days prior to registration:
a) A CT scan of the neck (with contrast) & a chest CT scan (with or without contrast);
b) or an MRI of the neck (with contrast) & a chest CT scan (with or without contrast);
c) or a CT scan of neck (with contrast) & a PET/CT of neck and chest (with or without contrast);
d) or an MRI of the neck (with contrast) & a PET/CT of neck and chest (with or without contrast).
Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as both staging&planning tools.
5. Patients must provide their personal smoking history prior to registration. The lifetime cumulative history cannot exceed 10 pack-years. Please refer to the protocol for details of pack-years calculation.
6. Zubrod Performance Status of 0-1 within 56 days prior to registration;
7. Age = 18;
8. The trial is open to both genders;
9. Adequate hematologic function within 14 days prior to registration, defined as follows:
? Absolute neutrophil count (ANC) = 1,500 cells/mm3;
? Platelets = 100,000 cells/mm3;
? Hemoglobin = 8.0 g/dl; Note: The use of transfusion or other intervention to achieve
Hgb = 8.0 g/dl is acceptable.
10. Adequate renal function within 14 days prior to registration, defined as follows:
? Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) = 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula as described in protocol section 3.2.10.
11. Adequate hepatic function within 14 days prior to registration defined as follows:
? Bilirubin < 2 mg/d
> Step 1: Registration
1. Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas;
2. Carcinoma of the neck of unknown primary site origin (even if p16 positive);
3. Radiographically matted nodes, defined as 3 abutting nodes with loss of the intervening fat plane;
4. Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;
5. Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles;
6. Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.
7. Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers;
8. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
9. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
10. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
11. Severe, active co-morbidity defined as follows:
? Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
? Transmural myocardial infarction within the last 6 months;
? Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
? Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;
? Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested in protocol section 3.2.10.
? Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition with immune compromise greater than that noted in protocol section 3.1.13; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements
may also exclude immuno-compromised patients.
12. Pregnancy; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
13. Prior allergic reaction to cisplatin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method