Clinical Trial RTOG 1203
- A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (Time-C)
- Principal Investigator
- Eric Donnelly
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.RTOG 1203
- The purpose of this study is to test whether the use of a radiation therapy delivery technique called intensity-modulated radiation therapy (IMRT) can reduce the amount and severity of gastrointestinal side effects (such as diarrhea) that result from radiation, compared with standard radiation techniques.
- This study is being done with women who have endometrial or cervical cancer. Many normal tissues, including the small and large bowel, are very close to areas at high risk of these cancers coming back, such as the lymph nodes and vagina. Standard radiation techniques cannot avoid delivering radiation to these normal tissues that do not need to get radiation. IMRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to the cancer and to areas that the study doctor thinks may have cancer cells, such as lymph nodes in the pelvis. IMRT does this by using multiple, complicated computer-controlled radiation beams aimed at your cancer.
Some of the eligibility criteria include:
- Participants must have either endometrial or cervical cancer that has been diagnosed within 90 days of beginning this study.
- Participants must have had a hysterectomy (this must have been done within 49 days of starting the study).
- Participants cannot have cancer that has spread outside of the pelvis.
- Participants must be 18 or older.
- Description of Treatment
- Participants in this study will be "randomized" into one of two study groups. Randomization means that participants are put into a group by chance. Participants in group 1 (called "Arm A") will receive IMRT. This radiation technique is not the standard technique in this setting. The radiation therapy will be given once daily, 5 days a week, for 5-6 weeks. The treatment takes about 5-15 minutes each day. Participants in group 2 (called "Arm B") will receive standard three-dimensional radiation therapy. This is the standard radiation technique in this setting. The radiation therapy will be given once daily, 5 days a week, for 5-6 weeks. The treatment takes about 5-15 minutes each day. Participants in both Arms may or may not receive weekly IV cisplatin chemotherapy (this will be decided by the doctor). The study doctor may decide that, in addition to the external beam treatment, participants may receive another type of radiation treatment known as a “vaginal cuff boost.” The vaginal cuff boost is where the physician places radiation inside the vagina to treat the top of the vagina. This internal treatment takes about 2-5 minutes for each treatment and will be given once or twice weekly.
- Clinical Trials Recruitment Nurse
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 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: 19-Aug-17 12:02 PM
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