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Head and Neck Cancer


Study Title

A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer.

Prinicipal Investigators

Study Number

RTOG 0920

Status of Trial

Open

Why is this study being done?

The standard treatment of surgery (which you have had) followed by radiation therapy can stop tumors from growing in the head and neck region in most patients. However, the cancer can recur or can spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development.  It was approved by the FDA in 2006 for the treatment of head and neck cancer.

The purpose of this study is to compare the effects, good and/or bad, of radiation therapy alone with radiation therapy and cetuximab on you and your cancer to find out which is better.  In this study, you will get either radiation therapy alone OR radiation therapy and cetuximab.

If you participate in this study, you will receive intensity modulated radiation therapy (IMRT). IMRT is a form of radiation in which radiation beams are designed to avoid important normal parts of your body, such as your salivary glands.

Your doctor also may decide to use a technique called image guided radiation therapy (IGRT). The purpose of IGRT is to give radiation treatment more accurately to your tumor while decreasing the radiation to normal tissues. Small adjustments in your radiation treatment are made each treatment day based on x-ray images taken right before each day's treatment to ensure that your radiation treatment is given as accurately as possible.

Use of IGRT may lead to improved accuracy of radiation treatment compared to regular radiation therapy and eventually, that will be more useful against cancer. At this time, however, there is no proof that using this technique is more useful against cancer than regular radiation treatment without this technique.

Contact

Romobia Hutchinson, BS
Email: HutchinsonR@cc.ucsf.edu


Study Title

A Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

Prinicipal Investigators

Study Number

RTOG 1016

Status of Trial

Open

Why is this study being done?

RATIONALE: 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 or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer.

PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.

Contact

Romobia Hutchinson, BS
Email: HutchinsonR@cc.ucsf.edu


Study Title

A Randomized Phase I I Study of Adjuvant Concur rent Radiation
and Chemotherapy versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors.

Prinicipal Investigators

Study Number

RTOG 1008

Status of Trial

Open

Why is this study being done?

The standard treatment for cancer of the salivary gland is surgery, and all patients will have had surgery before taking part in this study. Although the surgery may have removed your cancer, features of your disease suggest that you are at an increased risk for your cancer to return. In
patients at risk for disease recurrence after surgery, radiation therapy to the head and neck is frequently recommended after surgery. The purpose of this study is to test whether adding cisplatin, [an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug approved by the
Food and Drug Administration (FDA) for the treatment of various types of cancers]; to radiation therapy will improve the results after surgery and radiation therapy alone.

The study will compare the effects, good and/or bad, of radiation therapy and cisplatin (also called CDDP, Platinol®) with radiation therapy alone on you and your salivary gland cancer to find out
which is better at reducing the chance that your cancer will come back. This study is being sponsored and funded by the Radiation Therapy Oncology Group (RTOG). The UCSF investigators do not have a financial interest in the results of the study.

Contact

Romobia Hutchinson, BS
Email: HutchinsonR@cc.ucsf.edu


Study Title

A Phase I I Study of Concur rent IMRT, Paclitaxel and Pazopanib (NSC 737754) or Placebo, for the treatment of Anaplastic T hyroid Cancer

Prinicipal Investigators

Study Number

RTOG 0912

Status of Trial

Open

Why is this study being done?

Chemotherapy and radiation therapy to the neck is the standard treatment for anaplastic thyroid cancer at most institutions. The purpose of this study is to determine whether adding pazopanib to paclitaxel and radiation (chemoradiotherapy) is safe and tolerable. The study also will compare the effects, good and/or bad, of chemoradiotherapy and pazopanib with chemoradiotherapy and a placebo on you and your anaplastic thyroid cancer.

Pazopanib is a drug that interferes with cell communication and growth and reduces the growth of new blood vessels. It may delay the growth of tumor cells. It has been approved by the Food and Drug
Administration (FDA) for use in kidney cancers. It has not been approved by the FDA for patients with thyroid cancer, and is considered investigational (experimental) in this study. Paclitaxel is a chemotherapy drug that has been shown to have activity against anaplastic thyroid cancer. In anaplastic thyroid cancer cell lines (not in humans), pazopanib has had an anti-tumor effect, and in cancer cell lines, it also has enhanced the anti-tumor effects of paclitaxel. The placebo will look the same as pazopanib and is taken by mouth as a tablet like pazopanib, but it is a non-active substance. It will have no effect on your cancer.

Contact

Romobia Hutchinson, BS
Email: HutchinsonR@cc.ucsf.edu


Study Title

A Phase ll study of Radiation Therapy and Vismodegib, for the Treatment of Locally Advanced Basal Cell Carcinoma of the Head and Neck.

Prinicipal Investigators

Study Number

VISMO-122011

Status of Trial

Open

Why is this study being done?

Chemotherapy, radiation therapy, and surgery are standard treatments for basal cell carcinoma at most institutions. The purpose of this study is to determine whether adding vismodegib to radiation (chemoradiotherapy) is safe and tolerable. The purpose of this study is to assess the safety and tolerability of combined radiation therapy and vismodegib. This combination may increase the chances of the tumors being destroyed or unable to spread to other parts of the body in people with locally advanced basal cell carcinoma of the head and neck.

Contact

Romobia Hutchinson, BS
Email: HutchinsonR@cc.ucsf.edu


Study Title

Randomized Phase ll/lll Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk for Squamous Cell Cancer of the Head and Neck.

Prinicipal Investigators

Study Number

RTOG-1216

Status of Trial

Open

Why is this study being done?

First part of the study
The purpose of the this part of this study is to find out what effects, good and/or bad, one of the following treatments has on you and your cancer. In this part of the study, you will receive one of the following treatments:

° Standard treatment: radiation therapy and cisplatin

° Experimental treatment: radiation therapy and docetaxel

° Experimental treatment: radiation therapy, docetaxel, and cetuximab

Second part of the study
This part of the study will proceed only if certain results are achieved in the first part of the study.

The purpose of this part of this study is to compare the effects, good and/or bad, of the standard treatment (radiation therapy and cisplatin) with one of the experimental treatments chosen from the first part of the study (either radiation therapy and docetaxel or radiation therapy, cetuximab, and docetaxel) to find out which is better. In this part of the study, you will get either the standard treatment or the experimental treatment.

Contact

Romobia Hutchinson, BS
Email: HutchinsonR@cc.ucsf.edu