Clinical Trial RTOG 1304
- 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
- Principal Investigator
- Eric Donnelly
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.RTOG 1304
- The main purpose of this clinical trial is to study patients with positive nodes before chemotherapy who become negative after chemotherapy to see1) if, after lumpectomy (surgery to remove cancer), radiation to the breast and lymph nodes will be better than radiation only to the breast at keeping cancer from returning, and 2) if, after mastectomy (surgery to remove part or all of one or both breasts), radiation to the area where the breast used to be and to the lymph nodes is better than no radiation at keeping cancer from returning.
- For women with breast cancer who do not have cancer cells in the lymph nodes removed at surgery, radiation is usually given to the breast only after lumpectomy and not at all after mastectomy. For women with breast cancer who do have cancer cells in the lymph nodes removed at surgery, radiation is usually given to the breast and lymph nodes after lumpectomy; and after mastectomy, radiation is usually given to the area where the breast used to be and to the lymph nodes. Questions remain as to the best approach in patients with positive lymph nodes before any treatment that have no residual cancer cells after chemotherapy.
Some of the eligibility criteria include:
- Patients must have a positive lymph node prior to treatment.
- Participants must be women at least 18 years old.
- Participants must have had at least 12 weeks of standard neoadjuvant chemotherapy.
- Participants must have had either a lumpectomy or mastectomy.
- Description of Treatment
- Participants in this study will be randomized to Arm 1 or Arm 2. Participants in Arm 1 who had a lumpectomy will receive radiation to the breast. Those who have had a mastectomy will not receive radiation therapy. Participants in Arm 2 who have had a lumpectomy will receive radiation therapy to the breast and lymph nodes. Those who have had a mastectomy will receive radiation to the area where the breast used to be and to the lymph nodes.
- 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 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)
- A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (Time-C)
last updated: 24-Nov-14 01:58 AM
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