Oral Squamous Cell CarcinomaNCT05872880
TPExtreme Induced Chemotherapy Followed by Surgery and Radiotherapy in the Oral Carcinoma.
An observational study of Oral Squamous Cell Carcinoma and Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Research shows that most oral cancer patients are already locally advanced when first diagnosed. Even after surgery and radiation, nearly half of patients develop recurrence or metastasis. Even in patients who survive, there is a serious decline in quality of life due to the after-effects of surgery and radiation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Modified radical surgery and Radical surgery
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1.From 18 to 65 years old; 2. The ECOG score is 0 to 1; 3. Newly diagnosed patients with locally advanced resectable/potentially resectable stage ⅲ-ⅳb oral mucosal squamous cell carcinoma (T1-2N1-3M0, T3-4bN0-3bM0).
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
shujun Hu
About this study
Official title: 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.
Research shows that most oral cancer patients are already locally advanced when first diagnosed. Even after surgery and radiation, nearly half of patients develop recurrence or metastasis. Even in patients who survive, there is a serious decline in quality of life due to the after-effects of surgery and radiation. Many patients therefore refuse surgery and lose the treatment opportunity. Many studies at home and abroad have found that preoperative induction chemotherapy for locally advanced tumors can reduce tumor load, reduce tumor scope, eliminate distant micro metastases, reduce the risk of recurrence and metastasis, and improve organ preservation rate. It has been confirmed in many clinical studies and our clinical practice of oral cancer MDT(Multi-Disciplinary Treatment) that induction chemotherapy with TPExtreme protocol (cetuximab + albumin-paclitaxel + cisplatin) for patients with locally advanced oral cancer can significantly reduce the tumor with a good objective response, which can create good conditions for surgery. Therefore, for patients sensitive to induction chemotherapy, there are no authoritative guidelines and clinical studies to say what is the scope of surgery. One option is for the thoroughness of the tumor resection, which is still the same as the scope of the tumor before induction therapy, but the scope of the surgery is still large, and the damage to the patient's quality of life is also serious. The other option is to perform modified radical surgery according to the scope of residual tumor lesions after induction therapy, with less trauma and less damage to the quality of life. Postoperative radiotherapy (chemical) therapy is to reduce the risk of recurrence. Our preliminary clinical practice also shows that Patients sensitive to induction chemotherapy can obtain better survival rate and quality of life after comprehensive treatment including modified radical surgery. This treatment mode is feasible, but the overall efficacy evaluation needs further study. Therefore, in this real world prospective clinical study, patients with oral cancer sensitive to induction chemotherapy will be treated with modified radical surgery or traditional radical surgery in full compliance with the patient's wishes. Through clinical observation and follow-up statistics. To explore the effects of two treatment regimens on survival rate and quality of life in order to find the best treatment mode.
Read the detailed description
Statistics showed that 65% of patients with oral cancer had been locally advanced when they were first diagnosed, and the tumor load was large. Even after radical surgical resection and radiotherapy, about 45% of patients with locally advanced oral cancer still have recurrence or metastasis, and the prognosis is poor. Even if the patients survive, due to the damage to tissues and organs caused by large-scale surgical excision, they often have a greater impact on the functions and appearance of the patients, such as chewing, swallowing, language, etc., the quality of life of the patients is generally poor and the medical costs are relatively high. Many studies at home and abroad have found that preoperative induction chemotherapy for advanced tumors can shrink tumor scope, eliminate distant micro metastases, reduce the risk of recurrence and metastasis, and improve organ preservation rate. It has been confirmed in many clinical practice that induction chemotherapy with TPExtreme protocol (cetuximab + albumin-paclitaxel + cisplatin) for patients with locally advanced oral cancer can significantly reduce the tumor volume with a good objective response rate (up to about 80%), which can create good conditions for surgery. The specific scheme was albumin paclitaxel 200mg/m2 D1; Cisplatin 75mg/m2, divided into 2-3 days; Cetuximab 400mg/m2 D1(250mg/m2 D8,D15), one cycle of treatment is 21 days, a total of 2 courses. However, for patients sensitive to induction chemotherapy, there has been no clear guideline on how to define the scope of surgical resection after tumor shrinkage or even disappearance, and there is also a lack of relevant clinical research to explore this. According to the RECIST 1.1 guideline for response evaluation criteria in solid tumors, equal or more than 50% reduction in lesion size can be included in this study. Patients fit the clinical trial criteria divide into two groups according to the patient's wishes. One group is radical surgery, patients receive surgery based on the tumor size before induction therapy, the other group is modified radical surgery who undergoes surgery based on the tumor size after induction therapy. Radical surgery is more extensive than modified radical surgery, and often requires mandibulectomy and internal fixation, as well as free flap transplantation to repair and reconstruct oral and maxillofacial defects, so it may need to use some special equipment. Such as titanium plate and titanium nail for internal fixation, microvascular anastomosis device, etc. However, modified radical surgery has a relatively small surgical range and is less likely to use the above devices. And during the operation, the incisal margin was 1~1.5cm outside the tumor boundary. If necessary, the lower lip and mandible could be incised, the facial skin could be excised, the mandibular bone could be segmental excision, and the defects could be repaired by pedicle or free skin (bone) flap. At the same time, improved radical neck dissection was performed on both sides of the affected neck. In operation, multiple incisal margin rapid disease examination was performed during the operation to ensure negative incisal margin and complete resection of the residual tumor lesion. Under this premise, minimize surgical trauma and preserve the patient's organs and appearance. Postoperative radiotherapy (or chemoradiotherapy) therapy to reduce the risk of recurrence. Postoperative radiotherapy was performed within 4-6 weeks after surgery. Linear accelerator/conformal intensity modulated radiotherapy was used for radiotherapy, and primary site radiotherapy was performed once a day, 5 times a week. The specific dose of radiotherapy is: PGTV(residue)：66-70Gy/30-33f(2-2.2Gy/f), PGTVtb(no residue):60-66Gy/30-33f(2-2.2Gy/f) , PGTVnd/ndtb：60-70Gy/30-33f(2-2.2Gy/f), high risk PTV：60Gy/30f(2Gy/f), low risk PTV：54Gy/30f(1.8Gy/f)。Our preliminary clinical practice showed that more and more patients with oral cancer tend to accept relatively less traumatic surgical programs, and patients sensitive to induction chemotherapy can obtain better survival rates and quality of life through modified radical surgery and postoperative adjuvant radiotherapy. This treatment mode is feasible, but the overall efficacy evaluation needs further study. Therefore, in this real world prospective clinical study, patients with oral squamous cell carcinoma sensitive to induction chemotherapy will be treated with modified radical surgery or traditional radical surgery in full compliance with the patient's wishes (without any biased intervention in the patient's clinical medical treatment). Through clinical observation and follow-up statistics. To explore the effects of two treatment regimens on survival rate and quality of life in order to find the best treatment mode.
- Being tested
- Modified radical surgery, Radical surgery
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified radical surgeryProcedure or surgery
Also called TPExtreme induced chemotherapy, radiotherapy
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.
Radical surgeryProcedure or surgery
Also called TPExtreme induced chemotherapy, radiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Modified radical surgery | |
| 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. Receives: Procedure: Radical surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
From the day of enrollment until treatment failure, death from any cause, or the last follow-up, the end point was the first occurrence.
Measured: 60 months
Objective response rate
It refers to cases in which the tumor shrinks to complete and partial response after therapy.
Measured: 60 months
Major partial response
The pathological reaction of the primary tumor after induction therapy was defined as the residual survival tumor ≤10%.
Measured: 60 months
Secondary outcomes (3)
Overall survival
From the day of enrollment until death from any cause or the last follow-up.
Measured: 60 months
Locoregional failure-free survival
From the day of enrollment until local and/or regional recurrence or the last follow-up.
Measured: 60 months
Distant failure-free survival
From the day of enrollment until distant metastasis or the last follow-up.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Apr 2022
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Cancer Hospital, The Second Hospital University of South China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872880
- Sponsor's protocol ID
- 202211261
- Status last verified
- Nov 2022
- First submitted
- 8 Feb 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05872880
- Acronym / sponsor ID
- 202211261
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Hunan Cancer Hospital, The Second Hospital University of South China
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research shows that most oral cancer patients are already locally advanced when first diagnosed. Even after surgery and radiation, nearly half of patients develop recurrence or metastasis. Even in patients who survive, there is a serious decline in quality of life due to the after-effects of surgery and radiation. Many patients therefore refuse surgery and lose the treatment opportunity. Many studies at home and abroad have found that preoperative induction chemotherapy for locally advanced tumors can reduce tumor load, reduce tumor scope, eliminate distant micro metastases, reduce the risk of recurrence and metastasis, and improve organ preservation rate. It has been confirmed in many clinical studies and our clinical practice of oral cancer MDT(Multi-Disciplinary Treatment) that induction chemotherapy with TPExtreme protocol (cetuximab + albumin-paclitaxel + cisplatin) for patients with locally advanced oral cancer can significantly reduce the tumor with a good objective response, which can create good conditions for surgery. Therefore, for patients sensitive to induction chemotherapy, there are no authoritative guidelines and clinical studies to say what is the scope of surgery. One option is for the thoroughness of the tumor resection, which is still the same as the scope of the tumor before induction therapy, but the scope of the surgery is still large, and the damage to the patient's quality of life is also serious. The other option is to perform modified radical surgery according to the scope of residual tumor lesions after induction therapy, with less trauma and less damage to the quality of life. Postoperative radiotherapy (chemical) therapy is to reduce the risk of recurrence. Our preliminary clinical practice also shows that Patients sensitive to induction chemotherapy can obtain better survival rate and quality of life after comprehensive treatment including modified radical surgery. This treatment mode is feasible, but the overall efficacy evaluation needs further study. Therefore, in this real world prospective clinical study, patients with oral cancer sensitive to induction chemotherapy will be treated with modified radical surgery or traditional radical surgery in full compliance with the patient's wishes. Through clinical observation and follow-up statistics. To explore the effects of two treatment regimens on survival rate and quality of life in order to find the best treatment mode.
Detailed description
Statistics showed that 65% of patients with oral cancer had been locally advanced when they were first diagnosed, and the tumor load was large. Even after radical surgical resection and radiotherapy, about 45% of patients with locally advanced oral cancer still have recurrence or metastasis, and the prognosis is poor. Even if the patients survive, due to the damage to tissues and organs caused by large-scale surgical excision, they often have a greater impact on the functions and appearance of the patients, such as chewing, swallowing, language, etc., the quality of life of the patients is generally poor and the medical costs are relatively high. Many studies at home and abroad have found that preoperative induction chemotherapy for advanced tumors can shrink tumor scope, eliminate distant micro metastases, reduce the risk of recurrence and metastasis, and improve organ preservation rate. It has been confirmed in many clinical practice that induction chemotherapy with TPExtreme protocol (cetuximab + albumin-paclitaxel + cisplatin) for patients with locally advanced oral cancer can significantly reduce the tumor volume with a good objective response rate (up to about 80%), which can create good conditions for surgery. The specific scheme was albumin paclitaxel 200mg/m2 D1; Cisplatin 75mg/m2, divided into 2-3 days; Cetuximab 400mg/m2 D1(250mg/m2 D8,D15), one cycle of treatment is 21 days, a total of 2 courses. However, for patients sensitive to induction chemotherapy, there has been no clear guideline on how to define the scope of surgical resection after tumor shrinkage or even disappearance, and there is also a lack of relevant clinical research to explore this. According to the RECIST 1.1 guideline for response evaluation criteria in solid tumors, equal or more than 50% reduction in lesion size can be included in this study. Patients fit the clinical trial criteria divide into two groups according to the patient's wishes. One group is radical surgery, patients receive surgery based on the tumor size before induction therapy, the other group is modified radical surgery who undergoes surgery based on the tumor size after induction therapy. Radical surgery is more extensive than modified radical surgery, and often requires mandibulectomy and internal fixation, as well as free flap transplantation to repair and reconstruct oral and maxillofacial defects, so it may need to use some special equipment. Such as titanium plate and titanium nail for internal fixation, microvascular anastomosis device, etc. However, modified radical surgery has a relatively small surgical range and is less likely to use the above devices. And during the operation, the incisal margin was 1~1.5cm outside the tumor boundary. If necessary, the lower lip and mandible could be incised, the facial skin could be excised, the mandibular bone could be segmental excision, and the defects could be repaired by pedicle or free skin (bone) flap. At the same time, improved radical neck dissection was performed on both sides of the affected neck. In operation, multiple incisal margin rapid disease examination was performed during the operation to ensure negative incisal margin and complete resection of the residual tumor lesion. Under this premise, minimize surgical trauma and preserve the patient's organs and appearance. Postoperative radiotherapy (or chemoradiotherapy) therapy to reduce the risk of recurrence. Postoperative radiotherapy was performed within 4-6 weeks after surgery. Linear accelerator/conformal intensity modulated radiotherapy was used for radiotherapy, and primary site radiotherapy was performed once a day, 5 times a week. The specific dose of radiotherapy is: PGTV(residue)：66-70Gy/30-33f(2-2.2Gy/f), PGTVtb(no residue):60-66Gy/30-33f(2-2.2Gy/f) , PGTVnd/ndtb：60-70Gy/30-33f(2-2.2Gy/f), high risk PTV：60Gy/30f(2Gy/f), low risk PTV：54Gy/30f(1.8Gy/f)。Our preliminary clinical practice showed that more and more patients with oral cancer tend to accept relatively less traumatic surgical programs, and patients sensitive to induction chemotherapy can obtain better survival rates and quality of life through modified radical surgery and postoperative adjuvant radiotherapy. This treatment mode is feasible, but the overall efficacy evaluation needs further study. Therefore, in this real world prospective clinical study, patients with oral squamous cell carcinoma sensitive to induction chemotherapy will be treated with modified radical surgery or traditional radical surgery in full compliance with the patient's wishes (without any biased intervention in the patient's clinical medical treatment). Through clinical observation and follow-up statistics. To explore the effects of two treatment regimens on survival rate and quality of life in order to find the best treatment mode.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPExtreme induced chemotherapy was followed by modified radical surgery and radiotherapy | – | Procedure: Modified radical surgeryThe 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. |
| TPExtreme induced chemotherapy was followed by radical surgery and radiotherapy | – | Procedure: Radical surgeryThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1.From 18 to 65 years old; 2. The ECOG score is 0 to 1; 3. Newly diagnosed patients with locally advanced resectable/potentially resectable stage ⅲ-ⅳb oral mucosal squamous cell carcinoma (T1-2N1-3M0, T3-4bN0-3bM0).
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified radical surgeryAlso: TPExtreme induced chemotherapy, radiotherapyThe 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. | Procedure or surgery | TPExtreme induced chemotherapy was followed by modified radical surgery and radiotherapy |
| Radical surgeryAlso: TPExtreme induced chemotherapy, radiotherapyRadical 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. | Procedure or surgery | TPExtreme induced chemotherapy was followed by radical surgery and radiotherapy |
Primary outcome
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.
Objective response rate
Time frame: 60 months
It refers to cases in which the tumor shrinks to complete and partial response after therapy.
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%.
3 secondary outcomes
Overall survival
Time frame: 60 months
Locoregional failure-free survival
Time frame: 60 months
Distant failure-free survival
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma and Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact anjie min (1817313127, 403535180@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.