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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial Group | Experimental | 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. (1) Tumor bed (CTVtb): It was delineated based on the tumor extent shown in laryngoscopy, enhanced CT/MRI, or PET CT before induction therapy49. For patients with significant anatomical changes due to tumor regression, the CTVtb was adjusted, taking into account the patient's anatomy after induction chemotherapy and the initial state of the tumor; if a cavity appeared due to tumor regression, it was adjusted according to natural anatomical boundaries.(2) High-risk clinical target volume (CTV1): CTVtb plus a 5-10mm margin, with a prescribed dose of at least 60Gy in 30 fractions. (3) Low-risk clinical target volume (CTV2): CTV1 plus a 5-10mm margin. For hypo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head and Neck Cancers | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year region-free recurrence survival (RRFS) | Time to confirmed diagnosis of documented recurrence of cervical lymph nodes or death from any cause | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Defined as documented treatment progression or death from any cause. | 2-year |
| Distant metastasis-free survival (DMFS) | Defined as documented distant metastases or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun-Yan Chen | Contact | 020-87342926 | 86 | chenchuny@sysucc.org.cn |
| Ya-Ni Zhang | Contact | 020-87342926 | 86 | zhangyn1@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Liu-Wei Tang | The Ethics Committee of the Center for Cancer Prevention and Treatment, Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China | China |
Data supporting this study's findings are available from the PI (Chun-Yan Chen) upon reasonable request.
Commencing from the publication date of papers related to this study, with no end date.
Data will be collected using a case record form (CRF). The PI will securely maintain all trial records, CRFs, and study-related documents for ten years in the study office before archiving them in the Medical Records section. Access will be provided to the PI, CIs, and IEC with the appropriate permissions. The PI will also be responsible for overseeing communication with the IEC and DSMU to ensure ethical oversight and participant safety.
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Phase II trial
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| 2-year |
| Overall survival (OS) | Defined as a documented death due to any cause or last follow-up; regional recurrence pattern; and acute and late toxicity. | 2-year |
| Local recurrence-free survival (LRFS) | Defined as documented primary tumor recurrence or death from any cause | 2-year |
| Acute and Late Radiation Injuries | 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. | Day 1 of radiotherapy to 2 years post-treatment |
| Quality of life assessment | 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. | 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. |
| Quality of life assessment | 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). | 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. |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |