Clinical Trials Results
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Trial Name
Brief Summary
This phase II/III trial studies how well radiation therapy works when given together with
cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with
high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous
cell). Specialized radiation therapy that delivers a high dose of radiation directly to the
tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in
chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of
tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a
monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune
system attack the cancer, and may interfere with the ability of tumor cells to grow and
spread. The purpose of this study is to compare the usual treatment (radiation therapy with
cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy,
and using the usual treatment plus an immunotherapy drug, atezolizumab.
This phase II/III trials studies whether maintenance immunotherapy (nivolumab) following
definitive treatment with radiation and chemotherapy (cisplatin) result in significant
improvement in overall survival (time being alive) and progression-free survival (time being
alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive
oropharynx cancer that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy
such as cisplatin 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 rays to kill tumor cells and shrink tumors. Immunotherapy with
monoclonal antibodies, such as nivolumab, may help the body's immune system attack the
cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet
known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy
works better than chemotherapy and radiation therapy alone in treating patients with HPV
positive oropharyngeal cancer.
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.
There are two study questions we are asking in this randomized phase II/III trial based on a
blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally
advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard
concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if
there is no detectable EBV DNA in their plasma, then patients are randomized to either
standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still
detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and
fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high
energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin,
fluorouracil, gemcitabine hydrochloride, and paclitaxel 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. It is not yet known whether giving cisplatin and fluorouracil
is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in
treating patients with nasopharyngeal cancer.
This phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab
in treating patients with head and neck cancer that has spread to a local and/or regional
area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill
tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as durvalumab
or cetuximab, may help the body's immune system attack the cancer, and may interfere with the
ability of tumor cells to grow and spread. It is not known if radiation therapy with
durvalumab will work better than the usual therapy of radiation therapy with cetuximab in
treating patients with head and neck cancer.
This phase II/III trial studies how well a reduced dose of radiation therapy works with
nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive
oropharyngeal cancer that is early in its growth and may not have spread to other parts of
the body (early-stage), and is not associated with smoking. Radiation therapy uses
high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as
cisplatin, 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. Immunotherapy with
monoclonal antibodies, such as nivolumab, may help the body's immune system attack the
cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is
being done to see if a reduced dose of radiation therapy and nivolumab works as well as
standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.
This phase II/III trial studies how well sentinel lymph node biopsy works and compares
sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for
early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that
removes a smaller number of lymph nodes from your neck because it uses an imaging agent to
see which lymph nodes are most likely to have cancer. Standard neck dissection, such as
elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph
node biopsy surgery may work better in treating patients with early-stage oral cavity cancer
compared to standard elective neck dissection.
This phase III trial compares the effect of adding nivolumab to the usual chemotherapy
(cisplatin or carboplatin with gemcitabine) versus the usual chemotherapy alone in treating
patients with nasopharyngeal cancer that has come back (recurrent) or spread to other places
in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may
help the body's immune system attack the cancer, and may interfere with the ability of tumor
cells to grow and spread. Chemotherapy drugs, such as cisplatin, carboplatin, and
gemcitabine, 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. Giving nivolumab
with the usual chemotherapy may work better than the usual chemotherapy alone in treating
patients with nasopharyngeal cancer.
Clinical Trial Categories:
- Bone Cancer
- Brain Cancer
- Breast Cancer
- Cancer Control
- Companion Studies
- Gastrointestinal Cancer
- Genitourinary Cancer
- Gynecology (GYN) Cancer
- Head and Neck Cancer
- Leukemia
- Lung Cancer
- Lymphoma (Hodgkin's Disease, Non-Hodgkin's Lymphoma)
- Melanoma
- Multiple Myeloma
- Myelodysplastic Syndrome (MDS)
- Other Cancer Protocols
- Pancreas Cancer
- Sarcoma
- Skin Cancer
- Symptom Management