Last updated on November 2017

A Phase Iii Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The Outback Trial


Brief description of study

A Phase Iii Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The Outback Trial

Detailed Study Description

You are being asked to take part in this study because you have been diagnosed with cervical cancer which is locally advanced and not suitable for surgery. The alternative to treatment on this trial is to receive standard cisplatin chemotherapy given at the same time as radiation.

The purpose of this study is to compare standard treatment, radiation therapy combined with the chemotherapy drug cisplatin (chemo-radiation), to standard chemo-radiation therapy plus additional experimental chemotherapy with FDA approved agents carboplatin and paclitaxel to see if it reduces the risk of tumor recurrence and improves overall survival. Studies among patients with other cancer types have shown that the addition of more chemotherapy after chemo-radiation reduces the risk of tumor recurrence at other places in the body. This has not yet been clearly established for cervical cancer patients. Giving additional chemotherapy after initial standard treatment is known as ‘adjuvant chemotherapy’.

The objectives of this trial are to find out whether adjuvant chemotherapy (using two other drugs) after chemo-radiation will increase the chances of survival and reduce the risk of tumor recurrence in the pelvis and other places. The risk and severity of side effects and quality of life during and after treatment will also be evaluated and compared. This trial will help the researchers understand the safety and effectiveness of this new treatment regimen for cervical cancer.

In this trial one group will receive standard chemo-radiation alone, whereas the other group will receive standard chemo-radiation and then additional chemotherapy.

Another purpose of this study is to test samples of your tumor tissue (if available from a previous surgery or biopsy) and your blood to find out if any of these tests can be used in the future to determine which patients may respond to treatment, have a good prognosis, or have side effects.

Clinical Study Identifier: TX8135

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Pamela Treas

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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