At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed endometrial cancer (stage IB grade 3, IC any grade, IIA, IIB requiring postoperative pelvic radiotherapy; unstaged stage IB grade 2; or stage IIIC with pelvic lymph node positive only, para-aortic nodes negative, not receiving chemotherapy)
- ✓Histologically confirmed cervical cancer status post-radical or simple hysterectomy meeting specific risk criteria (positive pelvic nodes with negative para-aortic nodes, parametrial involvement with negative margins, or Sedlis criteria with 2 risk factors; simple hysterectomy with negative margins and negative nodes)
- ✓Hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry; endometrial cancer patients must have also undergone bilateral salpingo-oophorectomy
- ✓No metastatic disease outside the pelvis
- ✕Histologically confirmed papillary serous, clear cell, neuroendocrine (large or small cell), endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor
- ✕Prior radiotherapy to the pelvis with overlap of radiotherapy fields
- ✕Requirement for extended-field radiotherapy beyond the pelvis
- ✕Microscopic involvement of the resection margin (< 3 mm)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma
In Brief
A Phase 2 clinical trial evaluating cisplatin and intensity-modulated radiation therapy for Cervical Cancer and Endometrial Cancer. Completed, enrolled 106 participants across 153 sites in 2 countries.
Detailed Summary
RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. 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. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.