Pre-Surgery Chemotherapy + Surgery & Radiation for Sinus Cancer
Recruiting in Palo Alto (17 mi)
+139 other locations
NS
Overseen byNabil Saba
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: ECOG-ACRIN Cancer Research Group
Must not be taking: Investigational agents
Disqualifiers: Distant metastases, Leptomeningeal disease, Uncontrolled illnesses, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This randomized phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, you cannot be on investigational agents or have uncontrolled illnesses that interfere with the trial.
What data supports the effectiveness of this treatment for sinus cancer?
Research shows that using cisplatin and docetaxel together is effective for head and neck cancers, including sinus cancer, with some patients achieving complete response. Additionally, neoadjuvant chemoradiation (chemotherapy and radiation before surgery) with cisplatin or carboplatin followed by surgery has been effective for maxillary sinus cancer, with cisplatin showing a higher complete response rate.12345
Is the combination of docetaxel and cisplatin safe for humans?
The combination of docetaxel and cisplatin has been studied in patients with head and neck cancer and non-small cell lung cancer, showing it is generally well-tolerated. Neutropenia (a low level of white blood cells) is the main side effect, but severe nerve damage and kidney problems are uncommon.14678
What makes the pre-surgery chemotherapy treatment for sinus cancer unique?
This treatment is unique because it combines pre-surgery chemotherapy with carboplatin, cisplatin, and docetaxel, followed by surgery and radiation, which is not a standard approach for sinus cancer. The combination of these drugs is known to be effective in head and neck cancers, and using them together before surgery may enhance treatment outcomes.124910
Research Team
NS
Nabil Saba
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
This trial is for adults with nasal and paranasal sinus cancer that can be surgically removed. They should not have had prior radiation for head or neck tumors, no severe allergies to the chemo drugs used, and no other cancers in the last 2 years (except certain skin cancers). Participants need functioning major organs, no serious illnesses that could affect treatment, and women must not be pregnant.Inclusion Criteria
My cancer can be measured and I've had a scan within the last 2 weeks.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be within the range allowing for eligibility, must be obtained < 2 weeks prior to randomization
Total bilirubin within normal limits (must be obtained =< 2 weeks prior to randomization)
See 17 more
Exclusion Criteria
I do not have cancer that has spread far or to the lining of my brain.
I have not had radiation for tumors in my head, neck, skull base, or brain.
I do not have any other serious illnesses that would stop me from receiving cancer treatment.
See 1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Neoadjuvant Chemotherapy
Patients receive docetaxel and cisplatin or carboplatin every 21 days for up to 3 courses
9 weeks
3 visits (in-person)
Surgery
Patients undergo standard of care surgery
1 week
1 visit (in-person)
Post-operative Radiation
Patients undergo image guided intensity modulated radiation therapy (IMRT) for 30 fractions
6 weeks
30 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 5 years
Every 3 months if < 2 years from study entry, then every 6 months if 2-5 years from study entry
Treatment Details
Interventions
- Carboplatin (Platinum-based Chemotherapy)
- Cisplatin (Platinum-based Chemotherapy)
- Docetaxel (Taxane Chemotherapy)
- Image Guided Radiation Therapy (Radiation)
- Intensity-Modulated Radiation Therapy (Radiation)
- Therapeutic Conventional Surgery (Procedure)
Trial OverviewThe study compares two approaches: one group receives chemotherapy (docetaxel, cisplatin, carboplatin) before surgery and radiation therapy; the other has surgery followed by radiation only. The goal is to see if pre-surgery chemo makes tumors smaller and reduces how much normal tissue needs removal.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (docetaxel, cisplatin, carboplatin, surgery, IMRT)Experimental Treatment8 Interventions
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Patients who are ineligible to receive cisplatin receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery no later than 6 weeks following the last dose of chemotherapy. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV or carboplatin IV weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (surgery, IMRT, cisplatin, carboplatin)Active Control7 Interventions
Patients undergo standard of care surgery. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Paraplatin for:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
🇪🇺 Approved in European Union as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
🇨🇦 Approved in Canada as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Carle Physician Group-Mattoon/CharlestonMattoon, IL
Smilow Cancer Center/Yale-New Haven HospitalNew Haven, CT
Thomas Jefferson University HospitalPhiladelphia, PA
Idaho Urologic Institute-MeridianMeridian, ID
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research Group
Lead Sponsor
Trials
122
Patients Recruited
160,000+
National Cancer Institute (NCI)
Collaborator
Trials
14080
Patients Recruited
41,180,000+
References
Preliminary Study of Chemoradiotherapy Using Modified Docetaxel, Cis-diaminodichloroplatinum, and 5-Fluorouracil for Sinonasal Squamous Cell Carcinoma. [2022]To examine the safety and efficacy of concomitant chemoradiotherapy using a modified TPF regimen (docetaxel + cisplatin + 5-fluorouracil) in patients with advanced sinonasal squamous cell carcinoma (SNSCC).
Neoadjuvant chemoradiation in squamous cell carcinoma of the maxillary sinus: a 26-year experience. [2021]Background. The aim of our study was to evaluate the effects of neoadjuvant platinum-based radiochemotherapy (RCT) in patients with maxillary sinus squamous cell carcinoma and to compare the results with other multimodality treatment concepts for advanced-stage maxillary sinus carcinoma in the literature. Methods. In total, 53 patients with squamous cell carcinoma of the maxillary sinus were reviewed retrospectively. All patients received a neoadjuvant RCT containing either cisplatin or carboplatin followed by radical surgery. Overall survival and locoregional control were plotted by Kaplan-Meier analysis. Prognostic factors were identified through univariate and multivariate analysis. Results. Five-year overall survival for all patients was 35%. Eleven patients achieved a complete response after radiochemotherapy. The complete response rate was significantly higher for patients treated with cisplatin (P = 0.028); however the 5-year overall survival rates did not differ significantly (P = 0.673) for patients treated with cisplatin (37%) and carboplatin (32%). Orbital invasion (P = 0.005) and complete response to radiochemotherapy (P = 0.021) had a significant impact on overall survival in univariate analysis. Conclusions. Neoadjuvant radiochemotherapy followed by radical surgery is an effective treatment for patients with advanced maxillary sinus squamous cell carcinoma. In terms of treatment response cisplatin seems to be more effective than carboplatin.
The treatment of advanced sinonasal malignancies with pre-operative intra-arterial cisplatin and concurrent radiation. [2018]Malignancies of the nasal and paranasal sinuses are uncommon tumors, accounting for only 3% of all aerodigestive tract neoplasms. Despite advances in surgical techniques and continued evolution of adjuvant therapies, the 5-year mortality remains unusually high at greater than 50%. In 1996, we begin utilizing a novel strategy in the treatment of advanced sinonasal carcinomas. This consisted of neoadjuvant selective intra-arterial cisplatin with concurrent radiation therapy (acronym RADPLAT) followed by a conservative craniofacial resection. We now report our results for 11 patients treated with this regimen.
Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group. [2020]Docetaxel and cisplatin are among the most active antitumor agents in head and neck cancer, and phase I studies found the combination of the two drugs to be feasible. The EORTC ECSG performed a multicenter phase II study in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck to evaluate the antitumor efficacy and toxicity of this combination.
Craniofacial resection following chemotherapy. [2016]A patient with intracranial extension of an ethmoidal carcinoma is reported. Since the tumor progressed in size despite conventional radiation and chemotherapy, the patient was treated with Cis-dichlorodiamine platinum). Significant regression in the intracranial component was noted, thus allowing complete excision of the tumor through a craniofacial approach. Preoperative chemotherapy with this agent may have a role in the management of patients with paranasal sinus carcinoma if intracranial extension is present.
Docetaxel (Taxotere) in combination with platinums in patients with non-small cell lung cancer: trial data and implications for clinical management. [2018]Docetaxel (Taxotere; Aventis, Antony, France) is among the most effective agents for the treatment of non-small cell lung cancer and its use in combination with cisplatin is a logical development. Docetaxel has been combined with cisplatin and is well-tolerated with promising activity in phase II studies. Extensive phase II investigations in the first-line setting recorded response rates of 32% to 52% survival (median, 8 to 12 months) with 33% to 48% of patients alive at 1 year. Neutropenia is dose-limiting. However, the incidence of severe neuropathy is low and clinically significant nephrotoxicity is uncommon. Following these encouraging findings, the combination of docetaxel with cisplatin has been studied in two randomized phase III trials that compare the new combination against reference regimens. These studies have completed accrual and data are expected shortly. The combination of docetaxel with carboplatin is also active and feasible. Neutropenia is the main adverse event and grade II or III neurotoxicity is uncommon. In phase II trials combining doses of 65 to 100 mg/m2 docetaxel with doses of carboplatin designed to maintain an area under the curve of 5 to 7.5 mg/mL/min, response rates have ranged from 30% to 67%.
Docetaxel (Taxotere) in combination with platinums in patients with non-small cell lung cancer: Trial data and implications for clinical management. [2019]Docetaxel (Taxotere; Aventis, Antony, France) is among the most effective agents for the treatment of non-small cell lung cancer and its use in combination with cisplatin is a logical development. Docetaxel has been combined with cisplatin and is well-tolerated with promising activity in phase II studies. Extensive phase II investigations in the first-line setting recorded response rates of 32% to 52% survival (median, 8 to 12 months) with 33% to 48% of patients alive at 1 year. Neutropenia is dose-limiting. However, the incidence of severe neuropathy is low and clinically significant nephrotoxicity is uncommon. Following these encouraging findings, the combination of docetaxel with cisplatin has been studied in two randomized phase III trials that compare the new combination against reference regimens. These studies have completed accrual and data are expected shortly. The combination of docetaxel with carboplatin is also active and feasible. Neutropenia is the main adverse event and grade II or III neurotoxicity is uncommon. In phase II trials combining doses of 65 to 100 mg/m2 docetaxel with doses of carboplatin designed to maintain an area under the curve of 5 to 7.5 mg/mL/min, response rates have ranged from 30% to 67%.
Ligation of the ethmoid arteries in superselective intra-arterial infusion of cisplatin for advanced maxillary sinus cancer fed by the ophthalmic artery. [2023]Superselective cisplatin (CDDP) infusion via the external carotid artery system and concomitant radiotherapy (RADPLAT) provides favorable oncological and functional outcomes in patients with maxillary sinus cancer. However, targeted lesions are occasionally fed by the branch of the internal carotid artery.
Analysis of survival after induction chemotherapy in pyriform sinus carcinoma. [2019]Three hundred seventy-one primary squamous cell carcinomas of the pyriform sinus were treated at Hôpital Laennec from 1970 through 1984 and retrospectively analyzed. The local and regional treatment consisted of initial surgical resection followed by postoperative radiotherapy. Forty-three patients were not treated by induction chemotherapy; 95 patients received preoperative chemotherapy with bleomycin as a single agent; 98 patients received three preoperative courses of vincristine, methotrexate, bleomycin, or endoxan, and 46 patients were treated by three courses of induction chemotherapy consisting of cisplatin, bleomycin, methotrexate, or 5-fluorouracil. Seventy-two patients received less than 150 mg of bleomycin and 17 patients received only one or two cycles of multiple-agent chemotherapy. Survivals were higher when multiple-agent chemotherapy was employed as compared with single-agent induction chemotherapy. Further prospective investigations are necessary to confirm that induction chemotherapy enhances survival in pyriformk sinus cancers.
Analysis of long-term results of our combination therapy for squamous cell cancer of the maxillary sinus. [2019]Seventy-four patients between 1971 and 1982 in Period I and 32 patients between 1982 and 1987 in Period II with maxillary sinus squamous cell cancer were treated by combination therapy consisting of preoperative LINAC X-ray irradiation with 5-flourouracil intra-arterial chemotherapy followed by maxillectomy and primary reconstruction. In Period II, 21 patients received preoperative cisplatinum (CPPP) microcapsule chemoembolization and pepleomycin (PEP) i.m. and or postoperative CDDP i.v. with PEP i.m. in addition to the combination therapy administered in Period I depending on systemic conditions, tumor stage and histopathological type. Five and 10-year crude survival rates were 68.9% and 55.4%, respectively, for Period I and 71.9% and 56.3% for Period II, with no significant difference between the two trials. In 21 selected patients in Period II, who had additional chemotherapy with preoperative CDDP chemoembolization and/or postoperative i.v. infusion of CDDP with pepleomycin i.m., 5 and 10-year survival rates were 85.7% and 61.9%, respectively.