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NCT05872880

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

Sponsor: Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

Research shows that most oral cancer patients are already locally advanced when first diagnosed. Even after surgery and radiation, nearly half of patients develop recurrence or metastasis. Even in patients who survive, there is a serious decline in quality of life due to the after-effects of surgery and radiation. Many patients therefore refuse surgery and lose the treatment opportunity. Many studies at home and abroad have found that preoperative induction chemotherapy for locally advanced tumors can reduce tumor load, reduce tumor scope, eliminate distant micro metastases, reduce the risk of recurrence and metastasis, and improve organ preservation rate. It has been confirmed in many clinical studies and our clinical practice of oral cancer MDT(Multi-Disciplinary Treatment) that induction chemotherapy with TPExtreme protocol (cetuximab + albumin-paclitaxel + cisplatin) for patients with locally advanced oral cancer can significantly reduce the tumor with a good objective response, which can create good conditions for surgery. Therefore, for patients sensitive to induction chemotherapy, there are no authoritative guidelines and clinical studies to say what is the scope of surgery. One option is for the thoroughness of the tumor resection, which is still the same as the scope of the tumor before induction therapy, but the scope of the surgery is still large, and the damage to the patient's quality of life is also serious. The other option is to perform modified radical surgery according to the scope of residual tumor lesions after induction therapy, with less trauma and less damage to the quality of life. Postoperative radiotherapy (chemical) therapy is to reduce the risk of recurrence. Our preliminary clinical practice also shows that Patients sensitive to induction chemotherapy can obtain better survival rate and quality of life after comprehensive treatment including modified radical surgery. This treatment mode is feasible, but the overall efficacy evaluation needs further study. Therefore, in this real world prospective clinical study, patients with oral cancer sensitive to induction chemotherapy will be treated with modified radical surgery or traditional radical surgery in full compliance with the patient's wishes. Through clinical observation and follow-up statistics. To explore the effects of two treatment regimens on survival rate and quality of life in order to find the best treatment mode.

Official title: A Multicenter Prospective Real-world Study of TPExtreme Induced Chemotherapy Followed by Radical Surgery/Modified Radical Surgery and Radiotherapy in the Treatment of Locally Advanced Oral Squamous Cell Carcinoma.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

124

Start Date

2022-04-01

Completion Date

2026-09

Last Updated

2023-05-24

Healthy Volunteers

Conditions

Oral Squamous Cell Carcinoma Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

PROCEDURE

Modified radical surgery

The modified radical surgery was performed within 4 to 6 weeks after the end of the last chemotherapy, and local extended resection was performed according to the scope of the residual tumor lesions after induction therapy: the incisal margin was 1 to 1.5cm outside the boundary of the residual tumor lesions, and multi-point incisal rapid disease detection was performed intraoperatively to ensure negative incisal margin and complete resection of the residual tumor lesions. Under this premise, the surgical trauma should be minimized, and the organs and appearance of the patient should be preserved. For example, facial skin should not be penetrated, mandible should not be cut off, and tongue tissue should be preserved as much as possible. Direct suture or local tissue flap should be used to repair the defect during the operation. At the same time, improved radical neck dissection was performed on the affected side of the neck.

PROCEDURE

Radical surgery

Radical surgery was performed within 4 to 6 weeks after the end of the last chemotherapy, and a wide range of radical surgical resection was performed according to the tumor scope before induction therapy: the incisal margin was 1 to 1.5cm outside the tumor boundary before induction, the lower lip and mandible could be incised if necessary, the facial skin could be excised, the mandibular bone segmentectomy was feasible, and pedicle or free skin (bone) flap was used to repair the defect. At the same time, improved radical neck dissection was performed on both sides of the affected neck.

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.

Locations (1)

Xiangya Hospital, Central South University

Changsha, Hunan, China