Induction chemotherapy followed by surgery and radiotherapy for oral cancer

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.

This study is testing a new chemotherapy treatment for patients with advanced oral cancer to see if it can shrink tumors and improve their chances of successful surgery and recovery.

Quick facts

• Study type: Observational
• Enrollment: 124 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xiangya Hospital of Central South University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, cetuximab, radiation
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05872880 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of the TPExtreme induction chemotherapy protocol, which includes cetuximab, albumin-paclitaxel, and cisplatin, on patients with locally advanced oral squamous cell carcinoma. The goal is to reduce tumor size and improve surgical outcomes, thereby decreasing the risk of recurrence and metastasis. Patients will receive two cycles of chemotherapy before undergoing surgery and radiotherapy. The study aims to enhance organ preservation and improve the quality of life for patients who often face significant challenges after traditional treatments.

Who should consider this trial

Good fit: Ideal candidates are new patients diagnosed with locally advanced oral squamous cell carcinoma who can tolerate the proposed treatment regimen.

Not a fit: Patients with distant metastasis or those who cannot undergo surgery due to medical contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes and quality of life for patients with advanced oral cancer.

How similar studies have performed: Previous studies have shown promising results with similar induction chemotherapy approaches for advanced tumors, indicating potential for success in this study.

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.

Where this trial is running

Changsha, Hunan

• Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: anjie min

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