Evaluating neck treatment strategies for early oral cancer

The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor

This study is testing whether radiotherapy or surgery works better for people with early oral cancer who have certain risk factors, to see which treatment helps them more.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT03017053 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of radiotherapy compared to elective neck dissection in patients with early oral cancer who have poor pathological factors. It is a randomized, prospective, multicenter study where participants will undergo primary tumor resection followed by either radiotherapy or selective neck dissection. The primary endpoint is the neck control rate over two years, while secondary endpoints include disease-free survival and overall survival at various intervals, as well as quality of life assessments. The study seeks to clarify treatment standards for early oral cancer and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with early-stage oral squamous-cell carcinoma and specific pathological features.

Not a fit: Patients with distant metastasis, other malignancies, or those who have undergone prior treatments for their cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols that enhance survival rates and quality of life for patients with early oral cancer.

How similar studies have performed: Previous studies have indicated varying success with similar treatment approaches, but this specific comparison of radiotherapy versus neck dissection in this patient population is novel.

Eligibility criteria

Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document
2. Age≥ 18 and≤ 75 years
3. Clinical/ Histological/ cytological/ Imaging examination proven Oral/Oropharynx Squamous-cell carcinoma (Tongue, buccal mucosa, mouth floor, hard palate, Molar area), the depth of invasion \> 4mm in preoperative assessment
4. In line with clinical stage I / II stage (T1-2 N0 M0; AJCC 2010) and receiving surgical resection
5. KPS≥ 70
6. Normal bone marrow reserve function and normal liver, kidney function
7. Expected survival period≥ 6 months

Exclusion Criteria:

1. Inability to provide an informed consent
2. Evidence of oral distant metastasis or other malignancies
3. The patient has received prior surgery for primary tumor or lymph node ( except for biopsy )
4. Prior radiotherapy for primary tumor
5. The patient has previously received anti-tumor biological targeted therapy
6. The patient has received chemotherapy or immunotherapy for primary tumors
7. Prior malignancy within the previous 5 years (except for cured skin basal cell carcinoma or cervical carcinoma in situ)
8. With 3-4 grad Allergy to any drug in the treatment
9. Peripheral neuropathy\> 1 grade
10. Any unstable systematic disease (including active infection, uncontrolled high blood pressure, unstable angina, onset of angina within the last 3 months, congestive heart failure, myocardial infarction within the previous 12 months, severe arrhythmia needing drug treatment, liver, kidney or metabolic disease)
11. HIV positive
12. Chronic diseases requiring immune agents or hormone therapy
13. Pregnant or lactating women
14. Drug/alcohol abuse, psychological or spiritual illness that may interfere compliance to the study
15. Patients with epilepsy requiring medications (such as steroids or antiepileptic drugs)
16. The patient has participated in other experimental therapy studies within 30 days
17. Researchers believe that the situation is unsuitable for participation in the group

Where this trial is running

Shanghai

• Shanghai Ninth People's Hospital — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Chenping ZHANG, Ph.D — Shanghai Ninth People's Hospital Shanghai, China, 200011
• Study coordinator: Chenping ZHANG, Ph.D

Conditions: Oral Cancer, Neck dissection, Survival, Early oral cancer, Early oral cavity squamous cancer with node negative neck