TPExtreme Induced Chemotherapy Followed by Surgery and Radiotherapy in the Oral Carcinoma.

Launched by XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · May 14, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with advanced oral cancer, specifically oral squamous cell carcinoma. The study aims to see if a combination of chemotherapy (called TPExtreme) followed by surgery and radiation can improve survival rates and quality of life for patients. Researchers believe that starting with chemotherapy may shrink the tumor, making surgery easier and potentially less harmful to patients’ quality of life. Participants will be randomly assigned to either a standard type of surgery or a modified version that aims to be less invasive, based on how well their tumors respond to the chemotherapy.

To be eligible for this trial, participants must be newly diagnosed with advanced oral cancer, fit enough to tolerate the treatment, and willing to follow the study's requirements. They should not have received any prior cancer treatments and must be able to provide informed consent. If you decide to join, you will receive thorough monitoring and follow-up care throughout the study. This trial is currently recruiting participants, and it hopes to find the best treatment approach to help improve outcomes for individuals with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ECOG(Eastern Cooperative Oncology Group) score: 0\~1.
• • 2. New patients, confirmed by pathological biopsy for squamous cell carcinoma of the oral mucosa.
• • 3. Tumor site: the tongue body, mouth floor, gums, buccal mucosa, after the hard palate, molar area.
• • 4. TNM(Primary Tumor, Regional Node, Metastasis) staging (stage Ⅲ - Ⅳ B): T2-4bN0-3bM0.
• • 5. After the assessment of tumor can be excised completely, or after the induction therapy may be removed completely.
• • 6. can tolerate set by general treatment, no surgical contraindications, through the basin of chest CT + body Bone radionuclide scanning or PET-CT(Positron Emission Tomography / Computed Tomography) to rule out distant metastasis.
• • 7. Pregnancy tests were performed in women of childbearing age (15-49 years old) within 7 days before treatment and the results were negative; Fertile male and female patients must consent to the use of effective contraceptive measures to ensure that during the trial and three months after withdrawal of pregnancy.
• • 8. voluntarily signed informed consent and are willing and able to comply with the requirements of the study schedule follow-up, treatment, Laboratory testing and other research requirements.
• Exclusion Criteria:
• • 1. Have previously received relevant antitumor therapy, including chemotherapy, radiotherapy and immunotherapy.
• • 2. Refused to sign the informed consent.
• • 3. Patients who refuse to accept treatment options in clinical studies: patients who cannot get treatment to proceed smoothly; Patients unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.
• • 4. Known to be allergic to the drugs that may be used to treat it.
• • 5. For patients with poor general condition who cannot tolerate treatment. (Routine examination, such as three routine examinations, blood biochemical examination, electrocardiogram, chest radiograph, etc, to judge the general condition, when the results prompt HB(hemoglobin)\<60g/L, WBC(white blood count)\<3.0×10\^9/L, PLT(platelet count)\<80×10\^9/L, Serum creatinine\>133umol/L, it was considered that the general condition was poor and the treatment could not proceed smoothly, so conservative treatment was recommended)
• • 6. Staging did not meet the inclusion criteria: patients with early clinical T1-2N0 oral cancer or patients with distant metastatic M1.
• • 7. Assess patients who cannot be surgically resected, such as primary lesions or cervical metastases that invade vital structures such as the craniocerebral vital centers and carotid arteries.
• • 8. Pregnant or lactating women (pregnancy tests should be considered for sexually active women of childbearing age).
• • 9. Patients with past or current malignancies other than adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma.
• • 10. Participated in other clinical studies within the past 30 days.
• • 11. Other conditions assessed by the researchers that could compromise patient safety or poor compliance, such as having a serious illness (including mental illness), severely abnormal test results, and other family or social high-risk risk factors.