A Phase II Trial of TPF Induction Chemotherapy in cN2 OSCC Patients
NCT ID: NCT02285543
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2016-12-01
2023-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This prospective, interventional, randomized control trial was to evaluate the TPF induction chemotherapy have a better effects in the cN2 patients with locally advanced and resectable OSCC. The patients would receive TPF induction chemotherapy followed by radical surgery and post-operative radiotherapy (the experimental group) or radical surgery and post-operative radiotherapy (the control group).
The study had a power of 80% on the basis of an assumed 2-year survival rate of 62.4% in the experiment group and 36.9% in the control group, with use of a two-sided log-rank test at a level of significance of 0.05. The recruitment period would be 2 years, and the follow-up period would be 2 years, and 15% of patients would drop out early or be lost to follow-up. A total number of 101 patients were to be recruited with stplan 4.5 software calculation. （Department of Biostatics, MD Anderson Cancer Center, University of Texas，USA） The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed by radical surgery and post-operative radiotherapy. The palpable edges of the primary lesion (both the longest and shortest axis) were marked before induction chemotherapy by at least four points, which were 0.5cm away. The patients in the control group received the radical surgery and post-operative radiotherapy/chemoradiotherapy.
Induction chemotherapy: For the patients who were randomly assigned to receive TPF induction chemotherapy, peripherally inserted central catheter was firstly inserted before intravenous infusion, docetaxel(at a dose of 75mg/m2 of body surface area) was administered as a 2-hour intravenous infusion, followed by intravenous cisplatin(75 mg/m2), administered during a period of 2 to 3 hours. Then, 5-Fu(750 mg/m2/day) was administered as a 120-hour continuous intravenous infusion for 5 days. Induction chemotherapy was given every 3 weeks for 2 cycles, unless there was disease progression, unacceptable toxic effects, or withdrawal of consent by the patients. Dexamethasone was given before docetaxel infusion to prevent docetaxel-related hypersensitivity reactions, skin toxic effects, and fluid retention; prophylactic antibiotics were also given starting on day 5 of each cycle for 3 days. Hydration with diuretic and antiemetic treatment was also performed. Primary prophylaxis with recombinant granulocyte colony-stimulating factor was not suggested. Chemotherapy dose reductions were allowed for grade 3/4 toxicities occurring after cycle 1: 25% and 50% dose reductions of the three chemotherapy agents were suggested for grade 3 and grade 4 hematologic toxicities or gastrointestinal toxicities, respectively; 25% and 50% cisplatin dose reductions were suggested for grade 3 and grade 4 renal toxicities, respectively. Surgery was performed at least 2 weeks after completion of induction chemotherapy.
Surgery: Radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed. The safety margins of the primary lesion were 1.0-1.5cm far away from the palpable margins of the lesion; for patients who received induction chemotherapy, the safety margins were 1.0cm away from the marks that were placed before induction chemotherapy, to ensure the same extent surgery in both arms. Frozen sections during surgery were performed to confirm adequate margins.
Post-operative radiotherapy: Radiotherapy was arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy/day, 5 days/week for 6 weeks, and totally 54-60 Gy, in the patient with high risk features, such as positive surgical margin, extra capsular nodal spread, vascular embolism, concurrent chemotherapy with cisplatin 80mg/m2 was suggested.
A complete medical history was obtained and tumor assessment was performed at baseline. Clinical tumor response was assessed by clinical evaluation and imaging study and was characterized according to the criteria of response evaluation criteria in solid tumors (version 1.1) before surgery. Post-operative pathologic response was assessed by post-operative pathologic examination as good and bad response. A good response was defined as absence of any tumor cells (pathologic complete response) or presence of scattered foci of a few tumor cells (minimal residual disease with \<10% viable tumor cells); otherwise, a bad pathologic response was defined. Toxic effects were assessed weekly during and after completion of induction chemotherapy and radiotherapy according to the common terminology criteria for adverse events (version 3.0).
Overall survival was calculated from the date of randomization to the date of death; disease free survival was calculated from the date of randomization to tumor recurrence or distant metastasis or death from any cause; locoregional recurrence/distant metastasis free survival was calculated from the date of randomization to locoregional recurrence/distant metastasis of tumor or death from any cause. Time to locoregional recurrence/distant metastasis was calculated from the date of finishing treatment to tumor locoregional recurrence/distant metastasis. Patients were monitored by every three months in the first two years, every six months in the next 2 years, and once a year thereafter until death or data censoring.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TPF group
The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed with surgery and radiotherapy/chemoradiotherapy.
docetaxel:75mg/m2 cisplatin：75 mg/m2 5-Fu：750 mg/m2/day
TPF induction chemotherapy
TPF induction chemotherapy: 2 cycles; docetaxel(75mg/m\^2), cisplatin(75 mg/m\^2), 5-Fu(750 mg/m\^2/day) for 5 days; 16 days later, the 2nd cycle. 2 weeks later, surgery.
Surgery: radical resection and full neck dissection with reconstruction. Radiotherapy: 4-6 weeks after surgery, 1.8-2Gy/day, 5 days/week for 6 weeks, and totally 54-60Gy
surgery
In the TPF group,surgery was performed at least 2 weeks after completion of induction chemotherapy.Surgery group includes radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed.
radiotherapy
Radiotherapy was arranged 4 to 6 weeks after surgery.Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy(gray)/day, 5 days/week for 6 weeks, and totally 54-60 Gy.
Control group
The patients in the control group received the radical surgery and radiotherapy/chemoradiotherapy.
surgery
In the TPF group,surgery was performed at least 2 weeks after completion of induction chemotherapy.Surgery group includes radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed.
radiotherapy
Radiotherapy was arranged 4 to 6 weeks after surgery.Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy(gray)/day, 5 days/week for 6 weeks, and totally 54-60 Gy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TPF induction chemotherapy
TPF induction chemotherapy: 2 cycles; docetaxel(75mg/m\^2), cisplatin(75 mg/m\^2), 5-Fu(750 mg/m\^2/day) for 5 days; 16 days later, the 2nd cycle. 2 weeks later, surgery.
Surgery: radical resection and full neck dissection with reconstruction. Radiotherapy: 4-6 weeks after surgery, 1.8-2Gy/day, 5 days/week for 6 weeks, and totally 54-60Gy
surgery
In the TPF group,surgery was performed at least 2 weeks after completion of induction chemotherapy.Surgery group includes radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed.
radiotherapy
Radiotherapy was arranged 4 to 6 weeks after surgery.Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy(gray)/day, 5 days/week for 6 weeks, and totally 54-60 Gy.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sex: both males and females.
* Karnofsky performance status (KPS) \>60.
* Histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).
* Clinical stage III/IVA (T1-2, N2, M0 or T3-4, N2, M0, UICC\[International Union Against Cancer \]2002) with resectable lesions.
* Adequate hematologic function: white blood cell \>3,000/mm3, hemoglobin\>8g/L, platelet count\>80,000/mm3.
* Hepatic function: ALAT(alanine aminotransferase )/ASAT(aspartate transaminase ) \<2.5 times the upper limit of normal (ULN), bilirubin \<1.5 times ULN.
* Renal function: serum creatinine \<1.5 times ULN.
* Written informed consent
Exclusion Criteria
* Surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).
* Previous radiotherapy or chemotherapy.
* Other previous malignancies within 5 years.
* Can not tolerate the treatment protocol with systematic diseases such as history of severe pulmonary or cardiac diseases.
* Legal incapacity or limited legal capacity.
* Creatinine clearance \<30ml/min.
* Pregnancy (confirmed by serum or urine β-HCG) or lactation period
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lai-ping Zhong
Professor,PHD,DDS,MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TOPIC
Identifier Type: -
Identifier Source: org_study_id