Actively Recruiting
De-Escalation Postoperative Radiotherapy for Oral Squamous Cell Carcinoma With pCR/MPR.
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-05-21
103
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The prognosis of locally advanced oral squamous cell carcinoma(OSCC ) is poor, and there are still many problems to be solved in the current treatment paradigm. Neoadjuvant chemotherapy combined with immunotherapy can significantly improve the pCR and MPR rates in patients with locally advanced OSCC. For patients who achieve pCR and MPR after neoadjuvant therapy and surgery, it is still hotly debated regarding whether to implement postoperative de-escalation radiotherapy. Neoadjuvant therapy is an ideal predictor of radiosensitivity. In theory, neoadjuvant therapy can eliminate microscopic lesions, thereby reducing the dose and volume of irradiation. Continuous hyperfractionated accelerated radiotherapy (CHART, based on hyperfractionated radiotherapy, increasing daily or weekly treatments and shortening the total treatment duration, but reducing the total dose), is to give a higher dose of radiation to tumor tissue in a shorter period of time, so as to overcome the accelerated reproliferation and inhibit the repair of sublethal damage of tumor cells. It is beneficial to improve the local control rate of tumor, control the acute injury of normal tissue and the yield acceptable late treatment-related complications. The specific protocol was as follows: high-risk CTV area (CTV1), 45Gy in total, fraction dose of 1.5Gy, twice a day, bioequivalent dose (BED) of 51.75Gy; Low-risk CTV area(CTV2), 39Gy in total , fraction dose of 1.3Gy, twice a day, BED of 44.07Gy; A total of 30 radiotherapy fraction were performed 10 times a week for 3 weeks.
CONDITIONS
Official Title
De-Escalation Postoperative Radiotherapy for Oral Squamous Cell Carcinoma With pCR/MPR.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Untreated oral cavity carcinoma confirmed by tissue examination, staged T2-4N0M0 or T1-4N1-3M0, stages II-IVB according to AJCC 8th edition
- Surgical pathology shows complete response (no viable tumor cells) or major response (10% or fewer viable tumor cells)
- Negative surgical margins
- No extranodal extension
- Aged between 18 and 80 years
- ECOG performance status 0 to 1
- Life expectancy over 6 months
- Women of childbearing age agree to use contraception during treatment and for 3 months after
- Neoadjuvant therapy regimen decided by clinician
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Pregnant or breastfeeding women
- History of other cancers within 5 years except cured skin basal cell carcinoma, cervical in situ cancer, or thyroid papilloma
- Incomplete neoadjuvant therapy or radical surgery
- Recurrence or distant metastasis before postoperative radiotherapy
- Contraindications for radiotherapy, chemotherapy, immunotherapy, or targeted therapy
- Uncontrolled cardiac symptoms or diseases
- Serious infections
- History of immunodeficiency, including HIV or transplant history
- Active or recent tuberculosis infection
- Active hepatitis B or C infection
- History of substance abuse including psychotropic drugs, alcoholism, or drug use
- Any condition judged unsuitable for inclusion by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial hospital, Sun Yat-sen University
Guangzhou, China
Actively Recruiting
Research Team
B
Bi Zhuofei, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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