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.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• ECOG(Eastern Cooperative Oncology Group) score: 0\

• New patients, confirmed by pathological biopsy for squamous cell carcinoma of the oral mucosa.

• Tumor site: the tongue body, mouth floor, gums, buccal mucosa, after the hard palate, molar area.

• TNM(Primary Tumor, Regional Node, Metastasis) staging (stage Ⅲ - Ⅳ B): T2-4bN0-3bM0.

• After the assessment of tumor can be excised completely, or after the induction therapy may be removed completely.

• 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.

• 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.

• 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.

Locations
Other Locations
China
Xiangya Hospital, Central South University
RECRUITING
Changsha
Contact Information
Primary
anjie min
403535180@qq.com
1817313127
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 124
Treatments
TPExtreme induced chemotherapy was followed by modified radical surgery and radiotherapy
The effect was evaluated at three weeks after 2 cycles of TPExtreme(albumin-paclitaxel+cisplatin+cetuximab) induction chemotherapy according to the RECIST 1.1 guideline, lesion reduction by at least 50% can be included in our study. Patients choose modified radical surgery based on the tumor invasion scope after induction chemotherapy.~In this group, the incisal margin was located 1\~1.5cm outside the boundary of the residual tumor lesion after induced chemotherapy. At the same time, improved radical neck dissection was performed on both sides of the affected neck. Postoperative conventional radiotherapy(or chemoradiotherapy) was performed within 4 to 6 weeks after surgery.
TPExtreme induced chemotherapy was followed by radical surgery and radiotherapy
The effect was evaluated at three weeks after 2 cycles of TPExtreme(albumin-paclitaxel+cisplatin+cetuximab) induction chemotherapy according to the RECIST 1.1 guideline, lesion reduction by at least 50% can be included in our study. Patients choose radical surgery based on the tumor invasion scope before induction chemotherapy.~In this group, the incisal margin was located 1\~1.5cm outside the boundary of the tumor lesion before induced chemotherapy. At the same time, radical neck dissection was performed on both sides of the affected neck. Postoperative conventional radiotherapy(or chemoradiotherapy) was performed within 4 to 6 weeks after surgery.
Sponsors
Collaborators: Hunan Cancer Hospital, The Second Hospital University of South China
Leads: Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov