## Protocol Section
### Identification Module
**NCT ID:** NCT05341479

**Brief Title:** An Observational Study of Clinical Treatments for Patients With Oropharyngeal Carcinoma

**Official Title:** Department of Otorhinolaryngology, Eye & ENT Hospital

#### Organization Study ID Info
**ID:** FD-EENT-2022036
#### Organization
**Class:** OTHER
**Full Name:** Eye & ENT Hospital of Fudan University
### Status Module
#### Completion Date
**Date:** 2025-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-04-22

**Type:** ACTUAL

**Last Update Submit Date:** 2022-04-18

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-04-01

**Type:** ACTUAL

**Status Verified Date:** 2022-04

#### Study First Post Date
**Date:** 2022-04-22
**Type:** ACTUAL
**Study First Submit Date:** 2022-04-18
**Study First Submit QC Date:** 2022-04-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Eye & ENT Hospital of Fudan University

#### Responsible Party

**Investigator Affiliation:** Eye & ENT Hospital of Fudan University

**Investigator Full Name:** LeiTao

**Investigator Title:** Director

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a prospective, observational study evaluating the effect and efficiency of different clinical treatments for patients with oropharyngeal carcinoma (OPC). The selection of treatment for individual patient is based on tumor characteristics (tumor size and tumor location), a complete assessment of therapeutic effects (treatment effectiveness, possible dysfunction after operation, function maintenance, complications, etc.), and the preferences of doctors and patients.

**Detailed Description:** For early-stage oropharyngeal carcinoma (T1-2,N0), radiotherapy or resection of the primary tumor (transoral laser microsurgery, transoral robotic surgery, conventional transoral surgery, and open surgery) with ipsilateral or bilateral neck dissection are performed according to the guidelines of Chinese society of clinical oncology (CSCO, version 2021) and the NCCN guidelines (version 2021). Postoperative radiotherapy (RT) or chemoradiotherapy (CRT) should be considered for patients with adverse features (e.g., extranodal extension, positive margins, perineural invasion or vascular invasion).

For advanced oropharyngeal carcinoma (T1-2,N1-3/T3-4,N0-3), chemoradiotherapy (CRT), resection of the primary tumor (transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery, and open surgery) with ipsilateral or bilateral neck dissection or neoadjuvant therapy with appropriate therapy (surgical resection, RT or CRT) are performed according to the CSCO guidelines (version 2021) and the NCCN guidelines (version 2021). Postoperative radiotherapy (RT) or chemoradiotherapy (CRT) should be considered for patients with adverse features (e.g., pT3 or pT4 primary, pN2 or pN3 nodal disease, extranodal extension, positive margins, perineural invasion or vascular invasion).

This study aims to evaluate and compare the clinical outcomes of different medical treatments in patients with same TNM stage disease, overall and stratified by HPV expression. Demographic and clinicopathological characteristics of patients enrolled were also collected to assess their associations with treatment strategies and prognoses. The rates of overall survival, disease specific survival, disease free survival, local control, regional control, and progress-free survival are analyzed in the present study.

### Conditions Module

**Conditions:**

- Oropharynx Carcinoma

**Keywords:**

- Oropharynx carcinoma

- Treatment

- Survival outcomes

### Design Module

#### Bio Spec

**Description:** Whole blood, Tumor tissue (If available), Para-tumor tissue (If available)

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Early-stage OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021).

**Intervention Names:**

- Procedure: Surgery for early-stage OPC

**Label:** Surgical treatment for early-stage OPC

#### Arm Group 2

**Description:** Early-stage OPC patients treated with radiotherapy (RT) according to proper indications (CSCO 2021 and NCCN 2021).

**Intervention Names:**

- Radiation: RT for early-stage OPC

**Label:** RT treatment for early-stage OPC

#### Arm Group 3

**Description:** Advanced OPC patients treated with chemoradiotherapy (CRT) according to proper indications (CSCO 2021 and NCCN 2021).

**Intervention Names:**

- Radiation: CRT for advanced OPC

**Label:** CRT treatment for advanced OPC

#### Arm Group 4

**Description:** Advanced OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021).

**Intervention Names:**

- Other: Surgery for advanced OPC

**Label:** Surgical treatment for advanced OPC

#### Arm Group 5

**Description:** Advanced OPC patients treated with neoadjuvant treatment according to proper indications (CSCO 2021 and NCCN 2021).

**Intervention Names:**

- Procedure: Neoadjuvant treatment for advanced OPC

**Label:** Neoadjuvant treatment for advanced OPC

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Surgical treatment for early-stage OPC

**Description:** The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations.

Early-stage OPC patients (T1-2,N0) enrolled in this group will be treated with surgical resection. The surgical techniques of the primary tumor include transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery (e.g., CO2 laser resection), and open surgery. Ipsilateral neck dissection should be performed for patients enrolled in this group. For patients with OPC at or approaching the midline, bilateral neck dissection should be strongly considered.

Postoperative radiotherapy (RT) or system therapy/RT should be considered for patients with adverse features (e.g., extranodal extension, perineural invasion or vascular invasion).

**Name:** Surgery for early-stage OPC

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- RT treatment for early-stage OPC

**Description:** The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations.

Early-stage OPC patients (T1-2,N0) enrolled in this group will be treated with RT.

**Name:** RT for early-stage OPC

**Type:** RADIATION

#### Intervention 3

**Arm Group Labels:**

- CRT treatment for advanced OPC

**Description:** The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations.

Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with CRT.

**Name:** CRT for advanced OPC

**Type:** RADIATION

#### Intervention 4

**Arm Group Labels:**

- Surgical treatment for advanced OPC

**Description:** The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations.

Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with surgical resection. The surgical techniques of the primary tumor include transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery, and open surgery. Ipsilateral neck dissection should be performed for patients enrolled in this group. For patients with OPC at or approaching the midline, bilateral neck dissection should be strongly considered.

Postoperative radiotherapy (RT) or system therapy/RT should be considered for patients with adverse features (e.g., pT3 or pT4 primary, pN2 or pN3 nodal disease, extranodal extension, or vascular invasion).

**Name:** Surgery for advanced OPC

**Type:** OTHER

#### Intervention 5

**Arm Group Labels:**

- Neoadjuvant treatment for advanced OPC

**Description:** The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations.

Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with neoadjuvant treatment. The subsequent treatments include RT, system therapy/RT, and surgical resection with or without postoperative adjuvant therapy.

**Name:** Neoadjuvant treatment for advanced OPC

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The time between the treatment and the date of death from any causes

**Measure:** 3-year overall survival

**Time Frame:** Three years

#### Secondary Outcomes

**Description:** The time between the treatment and the first evidence of local recurrence

**Measure:** 3-year local control survival

**Time Frame:** Three years

**Description:** The time between the treatment and the first evidence of regional recurrence

**Measure:** 3-year regional control

**Time Frame:** Three years

**Description:** The time between the treatment and the date of death from oropharyngeal cancer

**Measure:** 3-year disease specific survival

**Time Frame:** Three years

**Description:** The time between the treatment and the first evidence of disease recurrence, metastasis or death from any cause

**Measure:** 3-year disease free survival

**Time Frame:** Three years

**Description:** The time between the treatment and the date of first documented disease progression or death from any cause

**Measure:** 3-year progress-free survival

**Time Frame:** Three years

**Description:** Quality of life as assessed with the MD Anderson Dysphagia Inventory (MDADI)

**Measure:** Quality of Life post treatment

**Time Frame:** One year and three years post treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Oropharyngeal cancer: Base of Tongue/Tonsil/Posterior Pharyngeal Wall/Soft Palate;
* T1, T2, T3, and T4 stage.
* Age 18 - 90.
* Male or female.
* Good compliance.
* No other severe related diseases that may impact the treatment (such as other tumors, severe heart, lung and central nervous system diseases, etc.).
* Negative pregnancy test (for female patients with fertility).
* Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin. Female patients do not have fertility. Female patients with postmenopausal status.

Exclusion Criteria:

* Patients who have previously been diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases.
* Patients with a known history of active tuberculosis (TB).
* Pregnant women or lactating women.
* The doctors believes that it is inappropriate for patients to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time \[within the past year\] or active suicidal ideation or behavior).

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** This prospective, observational study involves patients with T1-T4 stages oropharyngeal carcinoma, and we aim to evaluate and compare the oncological outcomes of different clinical treatments in patients with same TNM stage disease, overall and stratified by HPV expression. Demographic and clinicopathological characteristics of patients enrolled are also collected to assess their associations with treatment strategies and prognoses.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** doctortaolei@163.com

**Name:** Lei Tao, Dr.

**Phone:** +86 2164377134

**Role:** CONTACT

**Contact 2:**

**Email:** zxk199455@163.com

**Name:** Xiaoke Zhu

**Phone:** +86 18221615406

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** doctortaolei@163.com

- **Name:** Lei Tao, Dr.

- **Phone:** +86 2164377134

- **Role:** CONTACT

**Country:** China

**Facility:** Department of Otorhinolaryngology, Eye & ENT Hospital

**State:** Shanghai

**Status:** RECRUITING

**Zip:** 200031

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, China

**Name:** Lei Tao, Dr.

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

### Misc Info Module

- Version Holder: 2024-05-24
