Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Location status: Recruiting
Location contact
Chun-Yan Chen, Prof.
CONTACT
Ya-Ni Zhang, Dr.
CONTACT
NCT Number: NCT06630780
To explore the control rate and quality of life of participants with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy, and the cervical lymph node removal prophylactic irradiation ENI in the low-risk area.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, China
Location status: Recruiting
Chun-Yan Chen, Prof.
CONTACT
Ya-Ni Zhang, Dr.
CONTACT
In order to understand whether it can better protect normal tissues such as pharyngeal constriction muscles, thyroid, parotid glands, and submandibular glands without affecting the efficacy of tumors, and reduce the negative impact of radiotherapy on immunotherapy, the investigators plan to conduct a prospective phase II study to explore the control rate and quality of life of patients with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients received intensity-modulated conformal radiotherapy (IMRT). To ensure study quality, all IMRT plans were reviewed by the research team at Sun Yat-sen University Cancer Center. The delineation principles for the radiotherapy target volume of the primary tumor bed and normal tissues followed the consensus guidelines.
Time frame: 2-year
Time to confirmed diagnosis of documented recurrence of cervical lymph nodes or death from any cause
Time frame: 2-year
Defined as documented treatment progression or death from any cause.
Time frame: 2-year
Defined as documented distant metastases or death from any cause
Time frame: 2-year
Defined as a documented death due to any cause or last follow-up; regional recurrence pattern; and acute and late toxicity.
Time frame: 2-year
Defined as documented primary tumor recurrence or death from any cause
Time frame: Day 1 of radiotherapy to 2 years post-treatment
The acute radiation toxicity was assessed using the CTCAE 5.0 version, while the RTOG and EORTC late radiation toxicity scales were used to evaluate late toxicity.
Time frame: Baseline, during radiotherapy, at the end of radiotherapy, 3 months after the end of radiotherapy, 6 months after the end of radiotherapy, and thereafter according to routine follow-up until 2 years.
The Quality of Life (QoL) was assessed at baseline and during follow-up using the European Organization for the Head and Neck Cancer Module (QLQ-H&N35) version 1.0.
Time frame: Baseline, during radiotherapy, at the end of radiotherapy, 3 months after the end of radiotherapy, 6 months after the end of radiotherapy, and thereafter according to routine follow-up until 2 years.
The Quality of Life (QoL) was assessed at baseline and during follow-up using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
Contact information is provided by the study sponsor or research team.
Sun Yat-sen University
Other
A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma
Acronym: REPORT-HNSCC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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