Phase 2
N=106
Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery
Cervical Cancer · Endometrial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00331760 ↗Enrolled (actual)
106
Serious AEs
6.0%
Results posted
Jun 2013
Primary outcome: Primary: Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review) — 1; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); intensity-modulated radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review) |
1; 0 | — |
| SECONDARY Percentage of Patients With Grade 2+ Bowel Adverse Events |
27.9; 22.5 | 0.12 |
| SECONDARY Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events |
19; 30; 30; 48 | — |
| SECONDARY Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events |
12; 10; 12; 10 | — |
| SECONDARY Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant |
80 | — |
| SECONDARY Rate of Local-regional Failure at Five Years |
5; 8 | — |
| SECONDARY Rate of Distant Metastases at Five Years |
7; 14 | — |
| SECONDARY Rate of Disease-free Survival at Five Years |
88; 84 | — |
| SECONDARY Rate of Overall Survival at Five Years |
88; 92 | — |
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry
- Patients with endometrial cancer must have also undergone a bilateral salpingo-oophorectomy
- Histologically confirmed diagnosis of 1 of the following:
- Endometrial cancer meeting 1 of the following criteria:
- Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy
- Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease
- Stage IIIC with all of the following:
- Pelvic lymph node positive only
- Para-aortic nodes sampled negative
- Not receiving chemotherapy
- Cervical cancer meeting 1 of the following criteria:
- Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following:
- Positive pelvic nodes (negative para-aortic nodes)
- Microscopic parametrial involvement and negative margins
- Disease qualified by Sedlis criteria must have 2 of the following risk factors:
- 1/3 or more stromal invasion
- Lymph-vascular space invasion
- Large clinical tumor diameter (≥ 4 cm)
- Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan
- No requirement for extended-field radiotherapy beyond the pelvis
- No histologically confirmed papillary serous, clear cell, or neuroendocrine (either large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor
- No evidence of metastatic disease outside of the pelvis
- No microscopic involvement of the resection margin (< 3 mm)
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- WBC (white blood cell count) ≥ 4,000/mm³ (cervical cancer patients only)
- Absolute neutrophil count ≥ 1, 800/mm³ (cervical cancer patients only)
- Platelet count ≥ 100, 000/mm³ (cervical cancer patients only)
- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only)
- Creatinine clearance ≥ 50 mL/min (cervical cancer patients only)
- AST (aspartate aminotransferase) ≤ 2 times upper limit of normal
- Bilirubin ≤ 2 times upper limit of normal
- Patients must not exceed the weight and size limits of the treatment table or CT scanner
- No mental status changes or bladder control problems that would preclude study compliance with bladder-filling instructions
- No active inflammatory bowel disease
- No severe, active, concurrent illness, defined as any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring IV antibiotics
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- AIDS
- No history of allergy to cisplatin (cervical cancer patients)
- No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for ≥ 3 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields
- No prior platinum-based chemotherapy (cervical cancer patients)
- No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or pegfilgrastim)
- No concurrent prophylactic thrombopoietic agents
- No concurrent amifostine or other protective agents
Data sourced from ClinicalTrials.gov (NCT00331760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.