TPExtreme Induced Chemotherapy Followed by Surgery and Radiotherapy in the Oral Carcinoma.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorXiangya Hospital of Central South University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Modified radical surgery
Procedure/SurgeryThe 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 surgery
Procedure/SurgeryRadical 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.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: TPExtreme induced chemotherapy was followed by modified radical surgery and radiotherapy1 intervention
Group B: TPExtreme induced chemotherapy was followed by radical surgery and radiotherapy1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
60 months2
Objective response rate
It refers to cases in which the tumor shrinks to complete and partial response after therapy.
Time frame
60 months3
Major partial response
The pathological reaction of the primary tumor after induction therapy was defined as the residual survival tumor ≤10%.
Time frame
60 monthsSecondary outcomes
1
Overall survival
From the day of enrollment until death from any cause or the last follow-up.
Time frame
60 months2
Locoregional failure-free survival
From the day of enrollment until local and/or regional recurrence or the last follow-up.
Time frame
60 months3
Distant failure-free survival
From the day of enrollment until distant metastasis or the last follow-up.
Time frame
60 monthsOther outcomes
1
Changes in patients' quality of life during treatment
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.
Time frame
60 months2
Assessment of toxicity and general conditions during and after treatment
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.
Time frame
60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiangya Hospital of Central South University
Lead sponsor
Hunan Cancer Hospital
Collaborator
The Second Hospital University of South China
Collaborator
Source ClinicalTrials.gov