- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05872880
TPExtreme Induced Chemotherapy Followed by Surgery and Radiotherapy in the Oral Carcinoma.
A Multicenter Prospective Real-world Study of TPExtreme Induced Chemotherapy Followed by Radical Surgery/Modified Radical Surgery and Radiotherapy in the Treatment of Locally Advanced Oral Squamous Cell Carcinoma.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: anjie min
- Phone Number: 1817313127
- Email: 403535180@qq.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410008
- Recruiting
- Xiangya Hospital, Central South University
-
Contact:
- shujun Hu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ECOG(Eastern Cooperative Oncology Group) score: 0~1.
- New patients, confirmed by pathological biopsy for squamous cell carcinoma of the oral mucosa.
- Tumor site: the tongue body, mouth floor, gums, buccal mucosa, after the hard palate, molar area.
- TNM(Primary Tumor, Regional Node, Metastasis) staging (stage Ⅲ - Ⅳ B): T2-4bN0-3bM0.
- After the assessment of tumor can be excised completely, or after the induction therapy may be removed completely.
- can tolerate set by general treatment, no surgical contraindications, through the basin of chest CT + body Bone radionuclide scanning or PET-CT(Positron Emission Tomography / Computed Tomography) to rule out distant metastasis.
- Pregnancy tests were performed in women of childbearing age (15-49 years old) within 7 days before treatment and the results were negative; Fertile male and female patients must consent to the use of effective contraceptive measures to ensure that during the trial and three months after withdrawal of pregnancy.
- voluntarily signed informed consent and are willing and able to comply with the requirements of the study schedule follow-up, treatment, Laboratory testing and other research requirements.
Exclusion Criteria:
- Have previously received relevant antitumor therapy, including chemotherapy, radiotherapy and immunotherapy.
- Refused to sign the informed consent.
- Patients who refuse to accept treatment options in clinical studies: patients who cannot get treatment to proceed smoothly; Patients unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.
- Known to be allergic to the drugs that may be used to treat it.
- For patients with poor general condition who cannot tolerate treatment. (Routine examination, such as three routine examinations, blood biochemical examination, electrocardiogram, chest radiograph, etc, to judge the general condition, when the results prompt HB(hemoglobin)<60g/L, WBC(white blood count)<3.0×10^9/L, PLT(platelet count)<80×10^9/L, Serum creatinine>133umol/L, it was considered that the general condition was poor and the treatment could not proceed smoothly, so conservative treatment was recommended)
- Staging did not meet the inclusion criteria: patients with early clinical T1-2N0 oral cancer or patients with distant metastatic M1.
- Assess patients who cannot be surgically resected, such as primary lesions or cervical metastases that invade vital structures such as the craniocerebral vital centers and carotid arteries.
- Pregnant or lactating women (pregnancy tests should be considered for sexually active women of childbearing age).
- Patients with past or current malignancies other than adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma.
- Participated in other clinical studies within the past 30 days.
- Other conditions assessed by the researchers that could compromise patient safety or poor compliance, such as having a serious illness (including mental illness), severely abnormal test results, and other family or social high-risk risk factors.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TPExtreme induced chemotherapy was followed by modified radical surgery and radiotherapy
The effect was evaluated at three weeks after 2 cycles of TPExtreme(albumin-paclitaxel+cisplatin+cetuximab) induction chemotherapy according to the RECIST 1.1 guideline, lesion reduction by at least 50% can be included in our study. Patients choose modified radical surgery based on the tumor invasion scope after induction chemotherapy. In this group, the incisal margin was located 1~1.5cm outside the boundary of the residual tumor lesion after induced chemotherapy. At the same time, improved radical neck dissection was performed on both sides of the affected neck. Postoperative conventional radiotherapy(or chemoradiotherapy) was performed within 4 to 6 weeks after surgery. |
The modified radical surgery was performed within 4 to 6 weeks after the end of the last chemotherapy, and local extended resection was performed according to the scope of the residual tumor lesions after induction therapy: the incisal margin was 1 to 1.5cm outside the boundary of the residual tumor lesions, and multi-point incisal rapid disease detection was performed intraoperatively to ensure negative incisal margin and complete resection of the residual tumor lesions.
Under this premise, the surgical trauma should be minimized, and the organs and appearance of the patient should be preserved.
For example, facial skin should not be penetrated, mandible should not be cut off, and tongue tissue should be preserved as much as possible.
Direct suture or local tissue flap should be used to repair the defect during the operation.
At the same time, improved radical neck dissection was performed on the affected side of the neck.
Other Names:
|
TPExtreme induced chemotherapy was followed by radical surgery and radiotherapy
The effect was evaluated at three weeks after 2 cycles of TPExtreme(albumin-paclitaxel+cisplatin+cetuximab) induction chemotherapy according to the RECIST 1.1 guideline, lesion reduction by at least 50% can be included in our study. Patients choose radical surgery based on the tumor invasion scope before induction chemotherapy. In this group, the incisal margin was located 1~1.5cm outside the boundary of the tumor lesion before induced chemotherapy. At the same time, radical neck dissection was performed on both sides of the affected neck. Postoperative conventional radiotherapy(or chemoradiotherapy) was performed within 4 to 6 weeks after surgery. |
Radical surgery was performed within 4 to 6 weeks after the end of the last chemotherapy, and a wide range of radical surgical resection was performed according to the tumor scope before induction therapy: the incisal margin was 1 to 1.5cm outside the tumor boundary before induction, the lower lip and mandible could be incised if necessary, the facial skin could be excised, the mandibular bone segmentectomy was feasible, and pedicle or free skin (bone) flap was used to repair the defect.
At the same time, improved radical neck dissection was performed on both sides of the affected neck.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 60 months
|
From the day of enrollment until treatment failure, death from any cause, or the last follow-up, the end point was the first occurrence.
|
60 months
|
Objective response rate
Time Frame: 60 months
|
It refers to cases in which the tumor shrinks to complete and partial response after therapy.
|
60 months
|
Major partial response
Time Frame: 60 months
|
The pathological reaction of the primary tumor after induction therapy was defined as the residual survival tumor ≤10%.
|
60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 60 months
|
From the day of enrollment until death from any cause or the last follow-up.
|
60 months
|
Locoregional failure-free survival
Time Frame: 60 months
|
From the day of enrollment until local and/or regional recurrence or the last follow-up.
|
60 months
|
Distant failure-free survival
Time Frame: 60 months
|
From the day of enrollment until distant metastasis or the last follow-up.
|
60 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in patients' quality of life during treatment
Time Frame: 60 months
|
Patients' quality of life was assessed using the head and neck specific module First Edition (H&N35) of the Quality of Life Questionnaire - Core 30 Modules third Edition (QLQ-C30) developed by the European Organization for Research and Treatment of Cancer (EORTC).
The questionnaire was scored on a scale of 0 to 100, with higher scores indicating better functioning or quality of life, or heavier symptom load.
|
60 months
|
Assessment of toxicity and general conditions during and after treatment
Time Frame: 60 months
|
Acute subjective toxic reactions to chemoradiotherapy: According to NCI-CTC 5.0 criteria, subjective toxic reactions were evaluated once per cycle during chemotherapy and once per week during radiotherapy.
Objective acute toxic reactions of chemoraochemotherapy: According to the NCI-CTC 5.0 standard, blood routine and biochemical examination were performed before each course of chemotherapy, and once on the 3rd and 7th day after each course of chemotherapy and 1 day before the next course of chemotherapy.
Objective toxic reactions were assessed by weekly blood draws during radiotherapy.
The results with higher grades are taken as the comprehensive results.
When the grade of adverse event is greater than or equal to grade 3, the patient is considered unable to continue treatment successfully.
|
60 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202211261
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oral Squamous Cell Carcinoma
-
National Cancer Institute (NCI)CompletedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Recurrent Laryngeal Verrucous Carcinoma | Recurrent Oral Cavity Verrucous Carcinoma | Tongue... and other conditionsUnited States
-
Emory UniversitySynta Pharmaceuticals Corp.TerminatedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage I Hypopharyngeal Squamous Cell Carcinoma | Stage I Laryngeal Squamous Cell Carcinoma | Stage I Oropharyngeal Squamous Cell Carcinoma | Stage II... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedHuman Papillomavirus Infection | Stage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage IVB Oropharyngeal Squamous Cell Carcinoma | Stage IVC Oropharyngeal Squamous Cell Carcinoma | Stage I Oropharyngeal Squamous Cell Carcinoma | Stage II Oropharyngeal... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IV Hypopharyngeal Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage IVB Laryngeal Squamous Cell Carcinoma | Stage IVB Oropharyngeal Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
Shanghai Jiao Tong University School of MedicineCompletedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage III Oral Cavity Squamous Cell CarcinomaChina
-
National Cancer Institute (NCI)TerminatedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Stage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage... and other conditionsCanada, United States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Caregiver | Salivary Gland Squamous Cell Carcinoma | Malignant Head and Neck Neoplasm | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)TerminatedStage I Oral Cavity Squamous Cell Carcinoma | Stage II Oral Cavity Squamous Cell CarcinomaUnited States
-
NRG OncologyNational Cancer Institute (NCI)RecruitingOral Cavity Squamous Cell Carcinoma | Stage I Lip and Oral Cavity Cancer AJCC v8 | Stage II Lip and Oral Cavity Cancer AJCC v8 | Buccal Mucosa Squamous Cell Carcinoma | Floor of Mouth Squamous Cell Carcinoma | Gingival Squamous Cell Carcinoma | Hard Palate Squamous Cell Carcinoma | Lip Squamous Cell... and other conditionsUnited States, Canada
-
Mitchell MachtayNot yet recruitingSquamous Cell Carcinoma of the Oral Cavity or Oropharynx
Clinical Trials on Modified radical surgery
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingInflammatory Breast CancerItaly
-
Zheng LiuRecruitingChronic Sinusitis | Nasal Polyps | Endoscopic Sinus SurgeryChina
-
Shengjing HospitalRecruiting
-
First Affiliated Hospital Xi'an Jiaotong UniversityNot yet recruiting
-
Hospital de Câncer de PernambucoProfessor Fernando Figueira Integral Medicine Institute; Santa Casa de Misericórdia...CompletedUterine Cervical Neoplasms
-
University of Campania "Luigi Vanvitelli"CompletedOncologic Disorders | Nutritional and Metabolic Diseases
-
Mansoura UniversityMansoura University HospitalActive, not recruiting
-
Emilio RamosWithdrawnGallbladder Neoplasm Malignant PrimarySpain
-
Kocaeli UniversityUnknownSystemic Inflammatory Response Syndrome
-
Beijing Tongren HospitalCompletedChronic Rhinosinusitis (Diagnosis) | Surgery