Clinical Trial RTOG 1174
- A Phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone (ANZGOG 0902/GOG-0274/RTOG 1174)
- Principal Investigator
- Eric Donnelly
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.RTOG 1174
- 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 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. 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.
Some of the eligibility criteria include:
- Participants must be at least 18 years old.
- Participants must have stage IB1 and node positive, IB2, II, IIIB, or IVA disease.
- Participants may not have had previous pelvic radiotherapy or previous hysterectomy
- Description of Treatment
- Participants will be randomized into one of the following study groups: Arm A: Participants will receive chemo-radiation (standard radiation therapy plus cisplatin chemotherapy) only. Participants will receive standard external radiation therapy daily for five weeks. Following external radiation, intracavitary radiation (radiation delivered directly to the cervix through the vagina) will be administered. The radiation therapy will be given over eight weeks. The cisplatin chemotherapy will be given in five treatments, weekly during the course of the radiation therapy. At the completion of treatment, participants will be followed for up to 5 years. Arm B: Participants will receive standard chemo-radiation therapy as described in Arm A. Within 4 weeks of finishing radiation treatment, participants will start to receive additional chemotherapy called carboplatin and paclitaxel. These two drugs will be given on one day, repeated every 3 weeks for 4 total cycles. Participants will then be followed for up to 5 years.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy
- A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer
- A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (Time-C)
- A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
last updated: 27-Nov-14 02:36 PM
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