TPExtreme Induced Chemotherapy Followed by Surgery and Radiotherapy in the Oral Carcinoma.

NCT05872880 | Recruiting

• 1 other identifier: 202211261
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Squamous Cell Carcinoma; Locally Advanced Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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.

  60 months

• Objective response rate

  It refers to cases in which the tumor shrinks to complete and partial response after therapy.

  60 months

• Major partial response

  The pathological reaction of the primary tumor after induction therapy was defined as the residual survival tumor ≤10%.

  60 months

Secondary Outcomes (3)

• Overall survival

  60 months

• Locoregional failure-free survival

  60 months

• Distant failure-free survival

  60 months

Other Outcomes (2)

• Changes in patients' quality of life during treatment

  60 months

• Assessment of toxicity and general conditions during and after treatment

  60 months

Study Arms (2)

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.

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.

Procedure: Radical surgery

Interventions

Modified radical surgery PROCEDURE

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.

Also known as: TPExtreme induced chemotherapy, radiotherapy

TPExtreme induced chemotherapy was followed by modified radical surgery and radiotherapy

Radical surgery PROCEDURE

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.

Also known as: TPExtreme induced chemotherapy, radiotherapy

TPExtreme induced chemotherapy was followed by radical surgery and radiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Hunan Cancer Hospital: collaborator
• The Second Hospital University of South China: collaborator

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

anjie min

CONTACT

1817313127; 403535180@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: May 24, 2023
• Study Start: April 1, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 24, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)