Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT05872880

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

Led by Xiangya Hospital of Central South University · Updated on 2023-05-24

124

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

X

Xiangya Hospital of Central South University

Lead Sponsor

H

Hunan Cancer Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ECOG score of 0 or 1
  • Newly diagnosed squamous cell carcinoma of the oral mucosa confirmed by biopsy
  • Tumor located in tongue body, mouth floor, gums, buccal mucosa, posterior hard palate, or molar area
  • TNM stage II to III B: T2-4bN0-3bM0
  • Tumor assessed as completely resectable before or after induction therapy
  • Able to tolerate treatment with no surgical contraindications and no distant metastasis confirmed by CT, bone scan, or PET-CT
  • Negative pregnancy test within 7 days before treatment for women of childbearing age; agreement to use effective contraception during study and for 3 months after
  • Voluntarily signed informed consent and willing to comply with study requirements and follow-up
Not Eligible

You will not qualify if you...

  • Previous chemotherapy, radiotherapy, or immunotherapy for cancer
  • Refusal to sign informed consent
  • Inability or unwillingness to accept study treatment or comply with follow-up due to psychological, social, family, or geographic reasons
  • Known allergy to study-related drugs
  • Poor general condition preventing treatment (e.g., low hemoglobin, white blood cells, platelets, or high creatinine)
  • Early-stage oral cancer (T1-2N0) or distant metastasis (M1)
  • Tumors invading vital structures making surgery impossible
  • Pregnant or lactating women
  • History of other malignancies except treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid papillary carcinoma
  • Participation in other clinical trials within the past 30 days
  • Other serious illnesses or conditions assessed by researchers that compromise safety or compliance

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Xiangya Hospital, Central South University

Changsha, Hunan, China, 410008

Actively Recruiting

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Research Team

A

anjie min

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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