Radiation Therapy + Cisplatin for Head and Neck Cancer
Recruiting in Palo Alto (17 mi)
+208 other locations
Overseen ByRobert Ferris
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: ECOG-ACRIN Cancer Research Group
No Placebo Group
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is studying if using a specific type of energy treatment alone or with a drug is better for treating patients with advanced head and neck cancer after surgery. The energy treatment kills cancer cells, and the drug helps by stopping their growth or killing them. The drug has been used for many years in the treatment of advanced cancers, including head and neck cancers, and is known for its ability to enhance the effects of the energy treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Radiation Therapy + Cisplatin for Head and Neck Cancer?
Research shows that using intensity-modulated radiation therapy (IMRT) for head and neck cancer can improve survival rates and reduce side effects compared to older methods. Additionally, combining IMRT with cisplatin, a chemotherapy drug, has been studied for its effectiveness in controlling tumors and improving patient outcomes.
12345Is the combination of radiation therapy and cisplatin generally safe for treating head and neck cancer?
The combination of radiation therapy and cisplatin for head and neck cancer has been studied, and while it can cause side effects, it is generally considered to have an acceptable safety profile. Some patients may experience more severe side effects when chemotherapy is added, but most complete the treatment without needing to stop due to these effects.
36789How is the treatment of Radiation Therapy + Cisplatin for Head and Neck Cancer different from other treatments?
This treatment uses Intensity-Modulated Radiation Therapy (IMRT), which allows for more precise targeting of the tumor while sparing healthy tissue, potentially reducing side effects compared to conventional radiation therapy. Cisplatin, a chemotherapy drug, is used alongside IMRT to enhance the treatment's effectiveness.
35101112Eligibility Criteria
This trial is for adults with stage III-IVA squamous cell carcinoma of the head and neck who've had surgery. They should not have recurrent disease or multiple cancers, must be two years free from other cured cancers (except certain skin/cervix cancers), and can't have had prior radiation in the same area. Participants need proper kidney function, blood counts within normal ranges, no pregnancy or breastfeeding, and they must use contraception.Inclusion Criteria
My cancer is a type of squamous cell carcinoma in the head or neck, at stage III or IVA.
I've been cancer-free for 2 years, except for certain skin cancers or cervical pre-cancer.
My cancer has not come back or spread from its original site.
My white blood cell count is healthy.
I had surgery to completely remove my cancer with the goal of curing it.
My oropharynx tumor is not caused by HPV.
I haven't had radiation to my head or neck that would affect my current treatment area.
I can send a tissue sample from my surgery to Foundation Medicine.
Participant Groups
The study is examining if adding cisplatin to radiation therapy improves outcomes for patients post-surgery compared to radiation alone. It's a phase II trial where participants are randomly assigned to receive either both treatments or just radiation therapy.
2Treatment groups
Experimental Treatment
Group I: Arm B (IMRT, cisplatin)Experimental Treatment3 Interventions
Patients undergo IMRT QD 5 days a week and receive cisplatin IV over 1-2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (IMRT)Experimental Treatment2 Interventions
Patients undergo IMRT QD 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Intensity-Modulated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as IMRT for:
- Oropharyngeal cancer
- Head and neck cancers
- Prostate cancer
- Breast cancer
- Lung cancer
🇪🇺 Approved in European Union as IMRT for:
- Oropharyngeal cancer
- Head and neck cancers
- Prostate cancer
- Breast cancer
- Lung cancer
🇨🇦 Approved in Canada as IMRT for:
- Oropharyngeal cancer
- Head and neck cancers
- Prostate cancer
- Breast cancer
- Lung cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, MT
Sparta Cancer Treatment CenterSparta, NJ
Dayton Physicians LLC-Upper ValleyTroy, OH
Dayton Physicians LLC-WilsonSidney, OH
More Trial Locations
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Who is running the clinical trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Patterns of failure and toxicity after intensity-modulated radiotherapy for head and neck cancer. [2022]To determine the outcome of patients treated with intensity-modulated radiotherapy (IMRT) for head and neck cancer.
Improved survival using intensity-modulated radiation therapy in head and neck cancers: a SEER-Medicare analysis. [2022]Intensity-modulated radiation therapy (IMRT) is a technologically advanced, and more expensive, method of delivering radiation therapy with a goal of minimizing toxicity. It has been widely adopted for head and neck cancers; however, its comparative impact on cancer control and survival remains unknown. The goal of this analysis was to compare the cause-specific survival (CSS) for patients with head and neck cancers treated with IMRT versus non-IMRT from 1999 to 2007.
Cisplatin Weekly Versus Every 3 Weeks Concurrently with Radiotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinomas: What Is the Best Dosing and Schedule? [2020]The aim of this prospective randomized study is to compare cisplatin at 2 dose levels given concurrently with intensity modulated radiation therapy (IMRT) in the treatment of locally advanced HNSCC. The main objectives were to evaluate treatment toxicities, loco-regional control, tumor response and patients compliance.
Intensity-modulated radiation therapy in head-and-neck cancer, first report in Thailand. [2016]This is the first report in Thailand to evaluate the efficacy of using intensity-modulated radiotherapy (IMRT) in the primary treatment of head-and-neck cancer.
Feasibility study of moderately accelerated intensity-modulated radiotherapy plus concurrent weekly cisplatin after induction chemotherapy in locally advanced head-and neck cancer. [2013]To evaluate the feasibility and efficacy of moderately accelerated intensity-modulated radiation therapy (IMRT) along with weekly cisplatin, after induction chemotherapy, in patients with locally advanced unresectable head and neck cancer (HNC).
Oral complications of head and neck radiotherapy: prevalence and management. [2017]The aim of the study was to evaluate the short-term and long-term toxicity caused by radiation treatment in the head and neck with the technique of intensity-modulated radiotherapy (IMRT).
IMRT with the use of simultaneous integrated boost in treatment of head and neck cancer: acute toxicity evaluation. [2016]Acute toxicity has been evaluated in head and neck cancer patients treated with intensity-modulated radiotherapy using simultaneous integrated boost (SIB-IMRT). The basis of the treatment protocol is an irradiation in 30 fractions with a total dose: 66 Gy to the region of macroscopic tumor, 60 Gy to the region of high-risk subclinical disease and 54 Gy to the region of low-risk subclinical disease. Between December 2003 and September 2005, 38 patients with carcinoma of different locations in the head and neck region were irradiated. Five patients underwent concurrent chemotherapy (weekly cisplatin). Acute toxicity was evaluated according to Radiation Therapy Oncology Group toxicity scale for skin, mucous membrane, salivary glands, pharynx and esophagus and larynx. All 38 patients completed the therapy without urgency of interruption due to acute toxicity of radiotherapy. No patient experienced grade 4 toxicity. More severe toxicity was observed in patients with concurrent chemotherapy. The results confirm that the irradiation according to our SIB-IMRT protocol is a therapy with acceptable toxicity and there is a space for radiobiological enhancement of this regimen by concurrent chemotherapy, e.g. weekly cisplatin.
Comprehensive IMRT plus weekly cisplatin for advanced head and neck cancer: the University of Wisconsin experience. [2021]We retrospectively examined the treatment efficacy and toxicity profile of intensity-modulated radiotherapy (IMRT) plus concurrent weekly cisplatin chemotherapy in patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC).
Whole-Field Sequential Intensity-Modulated Radiotherapy for Local-Regional Advanced Head-and-Neck Squamous Cell Carcinoma. [2022]There is little published data on the technique and results of whole-field (WF) sequential intensity-modulated radiotherapy (S-IMRT) for patients with head-and-neck squamous cell carcinoma (HNSCC). We report the treatment outcomes, adverse events (AEs), and dosimetric parameters in local-regional advanced (LRA) HNSCC patients treated with the WF S-IMRT technique.
Intensity-modulated radiotherapy using simultaneous-integrated boost for definitive treatment of locally advanced mucosal head and neck cancer: outcomes from a single-institution series. [2019]The study aims to report outcomes for patients treated using intensity-modulated radiotherapy (IMRT) with simultaneous-integrated boost and weekly cisplatin for American Joint Committee on Cancer stage III/IV mucosal head and neck squamous cell carcinomas (HNSCCs).
Current strategies in radiotherapy of head and neck cancer. [2021]The Intensity Modulated Radiation Therapy (IMRT) together with Image Guided Radiation Therapy (IGRT) improves radiation therapy for head and neck cancer. On the one hand tumors can be better covered with radiation dose and on the other hand normal tissue can be better preserved. Carefully applied this leads to the same tumor control rate with reduced toxicity compared with conventional radiation therapy. Respective to the addition of systemic therapy to irradiation therapy, platinum based radiochemotherapy remains the standard of care and there are first indications, that at least in the primary treatment of head and neck cancer the addition of Cetuximab to a cisplatin-based radiochemotherapy did not improve outcome.
Intensity-modulated radiation treatment for head-and-neck squamous cell carcinoma--the University of Iowa experience. [2013]To review the University of Iowa experience with intensity-modulated radiotherapy (IMRT) in the treatment of head-and-neck squamous cell carcinoma.