The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
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|ClinicalTrials.gov Identifier: NCT03017053|
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Oral Cancer||Radiation: Radiotherapy Procedure: Elective neck dissection||Phase 4|
Objective: To evaluate the effect of radiotherapy on the neck of early oral cancer with poor pathologic factors.
This is a randomized, prospective, open, multicenter study. Intervention: Patients receive primary tumor resection followed by radiotherapy.
Control: Patients receive primary tumor resection with selective neck dissection.
2 years neck control rates
Disease-free survival (1, 2, 3, 5 years) Overall survival (3, 5 years) Quality of life
1 year, 2 years, 3 years, 5 years disease-free survival is defined as: patients proportion from the date of surgery completion to 1 year, 2 years, 3 years, 5 years did not find clear evidence of recurrence or metastasis.
3 years, 5 years overall survival is defined as: the proportion of patients who survived from the beginning of the study to the third and fifth year in the total enrollment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||July 2025|
Primary surgery & Radiotherapy
Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor
Active Comparator: Elective neck dissection
Primary surgery & Elective neck dissection
Procedure: Elective neck dissection
Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor
- Neck control rates [ Time Frame: 2 years ]
- Disease-free survival [ Time Frame: 1 year ]
- Disease-free survival [ Time Frame: 2 years ]
- Disease-free survival [ Time Frame: 3 years ]
- Disease-free survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017053
|Contact: Chenping ZHANG, Ph.Demail@example.com|
|Shanghai Ninth People's Hospital||Recruiting|
|Contact: Chenping ZHANG, Ph.D +86-21-63136856 firstname.lastname@example.org|
|Principal Investigator:||Chenping ZHANG, Ph.D||Shanghai Ninth People's Hospital Shanghai, China, 200011|