Phase 2
N=384
Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer
Cervical Adenocarcinoma · Cervical Adenosquamous Cell Carcinoma · Cervical Small Cell Carcinoma · Cervical Squamous Cell Carcinoma · Endometrial Clear Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00416455 ↗Enrolled (actual)
384
Serious AEs
9.4%
Results posted
Dec 2015
Primary outcome: Primary: The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen — 50; 65 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fludeoxyglucose F 18 (Radiation); positron emission tomography (Procedure); computed tomography (Procedure); ferumoxtran-10 (Drug); magnetic resonance imaging (Procedure); diagnostic lymphadenectomy (Procedure); lymph node biopsy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen |
50; 65 | — |
| PRIMARY The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen |
85; 88 | — |
| SECONDARY The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis |
83; 65 | — |
| SECONDARY The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis |
63; 93 | — |
| SECONDARY The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis |
81; 63 | — |
| SECONDARY The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis |
69; 83 | — |
| SECONDARY Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone |
42; 50 | — |
| SECONDARY Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone |
79; 48 | — |
| SECONDARY Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone |
77; 54 | — |
| SECONDARY Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone |
89; 93 | — |
| SECONDARY Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone |
62; 89 | — |
| SECONDARY Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone |
63; 85 | — |
| SECONDARY Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes |
9; 10 | — |
| SECONDARY Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node |
10; 6 | — |
| SECONDARY Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy |
1; 1; 7; 1; 1; 4 | — |
| SECONDARY Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients |
3; 21; 6; 3; 94 | — |
| SECONDARY Cause of Interruption in Radiation Therapy in Cervical Cancer Patients |
1; 1; 9; 14; 102 | — |
Summary
This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or endometrial cancer.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of 1 of the following:
- Invasive carcinoma of the cervix meeting all of the following criteria:
- Previously untreated, primary disease
- Locoregionally advanced (stage IB2, IIA [>= 4 cm], or IIB-IVA) disease
- Any cell type allowed
- High-risk endometrial carcinoma meeting 1 of the following criteria:
- Grade 3 endometrioid or non-endometrioid endometrial carcinoma (clear cell or serous papillary) or carcinosarcoma diagnosed from an endometrial biopsy or dilation and curettage or
- Grade 1 or 2 endometrioid endometrial carcinoma with cervical stromal involvement overt on clinical examination or confirmed by endocervical curettage
- Under consideration for chemoradiotherapy (patients with cervical cancer)
- Undergone appropriate surgery for cervical or endometrial carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
- Appropriate surgical candidate to undergo extraperitoneal or laparoscopic lymph node sampling OR hysterectomy and lymph node sampling
- No surgery for patients with advanced lymphadenopathy
- No recurrent invasive carcinoma of the uterus or uterine cervix regardless of previous treatment
- No known metastases to the lungs or scalene lymph nodes
- No metastases to other organs outside of the pelvis or abdominal lymph nodes at the time of the original clinical diagnosis
- Patients with endometrial cancer with known intraperitoneal disease are eligible provided they undergo pelvic and para-aortic lymphadenectomy per protocol
- Participants must be enrolled at an American College of Radiology Imaging Network (ACRIN)-affiliated institution that is accredited by Gynecologic Oncology Group (GOG)
- GOG performance status 0-2
- Creatinine within normal institutional limits OR, in participants with creatinine levels above institutional normal, glomerular filtration rate (GFR) must be > 60 mL/min; there is no lower limit of normal for serum creatinine for this protocol
- Ferritin levels = 200 mg/dL)
- No prior pelvic or abdominal lymphadenectomy
- No prior pelvic radiotherapy
- No prior anticancer therapy that would contraindicate study participation
- No ferumoxides within the past 2 weeks
- No investigational agents within the past 30 days
- No other concurrent investigational agents
Data sourced from ClinicalTrials.gov (NCT00416455). 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.