Clinical trial · Interventional
The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate management of the neck is therefore of paramount importance in the treatment of oral cancer. However, there is still some controversy on the treatment of early maxillofacial malignancies. Currently, investigators have no accurate uniform treatment standards, including the National Comprehensive Cancer Network (NCCN) recommended between surgery and radiotherapy options. Clinical evaluation indicated that lymph node-negative patients eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients with true node-negative, preventive cervical lymph node dissection is obviously over-treatment, and lower quality of life. Radiotherapy can avoid such surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elective neck dissection | Procedure | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- Primary surgery \& Radiotherapy
- interventionNames
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Elective neck dissection
- description
- Primary surgery \& Elective neck dissection
- interventionNames
- Procedure: Elective neck dissection
Primary outcomes (1)
- measure
- Neck control rates
- timeFrame
- 2 years
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available