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New treatment option for Oral Tongue Squamous Cell Carcinoma
Official title Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial
ClinicalTrials.gov ID: NCT07402525
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn whether postoperative radiotherapy can delay disease recurrence in patients with early-stage oral squamous cell carcinoma who have high-risk factors. The main question it aims to answer is: Is the clinical outcome of early-stage tongue squamous cell carcinoma patients with risk factors after tumor enlargement resection receiving postoperative radiotherapy better than that of patients with simple follow-up observation?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age ≥ 18 years old and ≤ 70 years old, gender not limited;
- Newly treated patients (who have not undergone radiotherapy, chemotherapy, or targeted therapy before);
- Complete resection of the tumor with naked eye and no residual tumor observed in postoperative pathology;
- The lesion is limited to the anterior 2/3 of the tongue (active part of the tongue);
- Postoperative pathological diagnosis was squamous cell carcinoma of the tongue;
You likely can't join if
- Patients who invade the oropharynx, mouth floor, cheeks, neck, and other organs;
- Have received chemotherapy or other anti-tumor drugs;
- Previously received radiation therapy for the head and neck area;
- Patients with active autoimmune diseases that require systemic treatment in the past;
- Pregnant or lactating women;
- Individuals with acute infections that are difficult to control;
See the full eligibility criteria
- Age ≥ 18 years old and ≤ 70 years old, gender not limited;
- Newly treated patients (who have not undergone radiotherapy, chemotherapy, or targeted therapy before);
- Complete resection of the tumor with naked eye and no residual tumor observed in postoperative pathology;
- The lesion is limited to the anterior 2/3 of the tongue (active part of the tongue);
- Postoperative pathological diagnosis was squamous cell carcinoma of the tongue;
- According to AJCC 8th edition, the pathological TNM staging is T1-2N0M0;
- Having at least one risk factor: vascular cancer thrombus, nerve invasion, moderate or low differentiation;
- The general status score of the Eastern Cancer Collaboration Group (ECOG) is 0-2 points;
- Not participating in other clinical trials within the previous 4 weeks prior to screening; If other trials fail to screen cases, but meet the requirements of this trial, they can be enrolled.
- Patients who invade the oropharynx, mouth floor, cheeks, neck, and other organs;
- Have received chemotherapy or other anti-tumor drugs;
- Previously received radiation therapy for the head and neck area;
- Patients with active autoimmune diseases that require systemic treatment in the past;
- Pregnant or lactating women;
- Individuals with acute infections that are difficult to control;
- Patients with drug abuse, drug abuse, long-term alcoholism and AIDS;
- The people also have other known invasive malignant tumors (excluding those with no evidence of tumor recurrence through treatment and a duration of more than 2 years);
- Researchers believe that there are other conditions that hinder patients from participating in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Chaoyang, Beijing Municipality, China
- Fuzhou, Fujian, China
- Guandong, Guangdong, China
- Harbin, Heilongjiang, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Dalian, Liaoning, China
- Shenyang, Liaoning, China
- Xi'an, Shaanxi, China
- Qingdao, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
- Huzhou, Zhejiang, China
- Ningbo, Zhejiang, China
- Wenzhou, Zhejiang, China
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Chaoyang, Beijing Municipality, China; Fuzhou, Fujian, China; Guandong, Guangdong, China; Harbin, Heilongjiang, China; Wuhan, Hubei, China and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.