Trial Title:
TPExtreme Induced Chemotherapy Followed by Surgery and Radiotherapy in the Oral Carcinoma.
NCT ID:
NCT05872880
Condition:
Oral Squamous Cell Carcinoma
Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Modified radical surgery
Description:
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.
Arm group label:
TPExtreme induced chemotherapy was followed by modified radical surgery and radiotherapy
Other name:
TPExtreme induced chemotherapy
Other name:
radiotherapy
Intervention type:
Procedure
Intervention name:
Radical surgery
Description:
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.
Arm group label:
TPExtreme induced chemotherapy was followed by radical surgery and radiotherapy
Other name:
TPExtreme induced chemotherapy
Other name:
radiotherapy
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. 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.
Criteria for eligibility:
Study pop:
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).
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. ECOG(Eastern Cooperative Oncology Group) score: 0~1.
2. New patients, confirmed by pathological biopsy for squamous cell carcinoma of the
oral mucosa.
3. Tumor site: the tongue body, mouth floor, gums, buccal mucosa, after the hard
palate, molar area.
4. TNM(Primary Tumor, Regional Node, Metastasis) staging (stage Ⅲ - Ⅳ B): T2-4bN0-3bM0.
5. After the assessment of tumor can be excised completely, or after the induction
therapy may be removed completely.
6. 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.
7. 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.
8. 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:
1. Have previously received relevant antitumor therapy, including chemotherapy,
radiotherapy and immunotherapy.
2. Refused to sign the informed consent.
3. 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.
4. Known to be allergic to the drugs that may be used to treat it.
5. 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)
6. Staging did not meet the inclusion criteria: patients with early clinical T1-2N0
oral cancer or patients with distant metastatic M1.
7. 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.
8. Pregnant or lactating women (pregnancy tests should be considered for sexually
active women of childbearing age).
9. Patients with past or current malignancies other than adequately treated
non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary
carcinoma.
10. Participated in other clinical studies within the past 30 days.
11. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xiangya Hospital, Central South University
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Recruiting
Contact:
Last name:
shujun Hu
Start date:
April 1, 2022
Completion date:
September 2026
Lead sponsor:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
The Second Hospital University of South China
Agency class:
Other
Source:
Xiangya Hospital of Central South University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05872880
