Stage I to II Squamous Cell Carcinoma
Conditions
Sponsors
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 82 Years
Inclusion criteria
Inclusion criteria: 1. According to the AJCC provisions, stage I to II head and neck squamous cell carcinoma (SCCHN) or lymphatic epithelial tumor patients with T1 or T2 lesions (Note: unless there is a corresponding symptoms or do not have to exclude the central nervous system imaging studies of patients with central nervous system metastases) are eligible; but patients with sarcoma, salivary gland lymphoma, nasopharyngeal carcinoma are not permitted; 2. The tumor is easily touched, and can be confirmed by physical examination, CT scan or MRI examination; 3. The patient has histological biopsy diagnosis SCCHN or SCSC; 4. Must have sufficient tumor tissue for pathological analysis (frozen specimens from open biopsy or core needle aspiration core biopsy, or wax block); 5. The patient age =18 years old; 6. Female patients of childbearing potential must have a negative pregnancy test at study entry and must agree to use an acceptable form of birth control for the duration of the study; 7. ECOG Performance Status is 0 to 2; 8. The patient's life expectancy is greater than 6 months; 9. The patient is able to tolerate localized injections of PTS; 10. The patient has adequate bone marrow, renal, and hepatic function as evidenced by .absolute neutrophil count= 2 x 10^9; .platelet count=100 x 109; .creatinine=177 µmol/L; .total bilirubin=34.2 µmol/L; .ALT and AST=2 x Upper Limit of Normal (ULN), and .alkaline phosphatase=5 x ULN. 11. The patient must test negative for human immunodeficiency virus (HIV); 12. The patient is capable of understanding and complying with the protocol and has signed the informed consent document.
Exclusion criteria
Exclusion criteria: 1. Patient with distant metastases; 2. Patient with primary disease, nasopharyngeal cancer, salivary gland cancer, thyroid cancer, or sarcoma; 3. Patients suffering from lymphoma; 4. Patient with severe concomitant diseases, including non-control of the infection or serious heart, liver, kidney, or blood dysfunction; 5. Patient is pregnant or nursing woman; 6. Known patient allergies or related compound of the PTS; 7. weeks within entering the trial patient has a SCCHN systemic anticancer therapy, or has the nitrosourea (Nitrsourea) or mitomycin-C systemic treatment within 6 weeks; 8. The patient has participated in clinical studies of nonapproved experimental agents or procedures within 4 weeks prior to study entry; 9. In addition to the study disease, patient has a history of malignancy, unless the patient is radical and sustained remission for more than 2 years; 10. Patients with a history of homologous or heterologous transplantation; 11. The patient has radiation therapy at the tumor region within 8 weeks; 12. Patient suffering from other life-threatening complication; 13. Patients unwilling to comply with the test program provides test procedures or unwilling to cooperate fully with the investigator; 14. Patient suffering from other life-threatening complications need to be pre-empting by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the histologic and pathologic changes of tumor tissue & connected adjacent normal tissue;Efficacy Evaluation (RECIST & WHO Standard); | — |
Countries
China
Contacts
Public ContactPing-Zhang Tang
Outcome results
None listed