Oral Squamous cell carcinoma
Conditions
Interventions
control group:surgery+post-radio(chemo)therapy
experimental group:TPF induction chemotherapy+surgery+post radio(chemo)therapy
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age from 18 to 75 years old, male or female; (2) First-diagnose patient confirmed by pathological biopsy as squamous cell carcinoma; (3) Tumor site: tongue, mouth floor, gums, buccal mucosa, hard palate, Posteriormolars; (4) TNM staging: T1-2N1-2M0, T3-4aN0-2M0 (T4a tumor primary lesions can be completely removed); (5) Systemic conditions can tolerate the development of treatment, no surgical contraindications, Excluding distant metastases through chest radiographs, hepatobiliary and splenorenal abdomen B-scanning, and systemic skeletal radionuclide scans; (6) Women of childbearing age (15-49 years) undergoing a pregnancy test within 7 days prior to treatment with negative results; fertility The male and female patients must agree to use effective contraceptive measures to ensure that they are not pregnant during the trial period and within 3 months after discontinuation; (7) Patients who voluntarily signed informed consent and take part in the study.
Exclusion criteria
Exclusion criteria: (1) Written informed consent was not obtained; (2) Patients who refuse to undergo surgical treatment: The treatment cannot be performed successfully, and conservative treatment may be recommended; (3) Patients with poor general condition and who cannot tolerate treatment: Routine examinations, such as routine examinations of blood biochemical examinations, electrocardiograms, chest radiographs, etc., determine the general condition, HB 133umol/L, it is considered that the general condition is poor and the treatment cannot be performed successfully. A conservative treatment method may be recommended; (4) In patients with distant metastases M1, chemotherapy is generally recommended but not included in this study; (5) T1-2N0 patients: These patients generally belong to the early clinical stage and are not included in this study; (6) Patients who cannot be surgically removed: Such patients often cannot achieve the goal of complete surgical resection, such as primary or cervical metastases, and invade important tissue structures, such as the cranial brain and carotid artery, and are not included; (7) Pregnant or lactating women; (8) Have participated in other clinical trials within the past 30 days; (9) Other investigators consider it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Countries
China
Contacts
Public ContactZhang Chen-ping
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed