Local Recurrence and/or Neck lymph node metastasis of Head and Neck Cancer after Radiotherapy and Chemotherapy
Conditions
Interventions
PLDR group:pulsed low dose rate radiotherapy, qd, 5F/W, GTV 66-70Gy/33-34F. At the same time, patients will receive single or double drug chemotherapy based on cisplatin (2-4 cycles), which can be com
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged from 18 years to 75 years; 2. Patients must have histologically-confirmed malignant tumors; 3. Patients with head and neck tumors after radiotherapy and chemotherapy must have local recurrence and/or cervical lymph node metastasis; 4. No distant metastasis; 5. Eastern Cooperative Oncology Group (ECOG) performance status determined to be between 0 and 2; 6. Patient is not a surgical candidate or tumor is not surgically resectable, as documented by surgical oncologist; 7. The consciousness of patients is clear to cooperate with the placement and treatment; 8. The information of previous radiotherapy can be obtained, including the total dose of target area, the mode of segmentation, the distribution of dose, the dose of normal tissue and the iso-dose curve; 9. Patients must have measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 in the irradiated field; 10. Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed; 11. Absolute neutrophils count (ANC)>1.0*10^9/L; 12. Platelet (PLT)=75*10^9 /L; 13. The subjects must sign a written informed consent form and be willing to participate in and complete the study and follow up.
Exclusion criteria
Exclusion criteria: 1. patients with malignant tumor other than tumor of head and neck; 2. Patients who have had radiotherapy to the reirradiation target within 4 weeks prior to entering the study; 3. ECOG>2; 4. A history of ataxia telangiectasia or other documented history of radiation hypersensitivity; 5.Scleroderma or active connective tissue disease; 6. severe, uncontrollable infectious diseases; 7. Uncontrolled intercurrent illness including, such as severe mental illness or mental disorders, central nervous system disorders, cardiovascular and cerebrovascular complications, epilepsy and other diseases,that would limit compliance with study requirements; 8. Patients who do not want to sign an informed consent or not be willing to participate in this study; 9. Any other physical conditions that researchers believed will increase the risk of radiation related toxicity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Side effects of pulsed low dose rate radiation therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Palliative effect of quality of life and pain;Duration of Response;Time To Progress; | — |
Countries
China
Contacts
Public ContactPeng Zhang
Sichuan Cancer Hospital
Outcome results
None listed