Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Stage I Cervical Cancer
Conditions
Brief summary
This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
Detailed description
OBJECTIVES: I. Determine the sensitivity of the sentinel lymph node in the determination of lymph node metastases, using preoperative or intraoperative lymphatic mapping, in patients with stage IB1 cervical cancer. II. Determine the false-negative predictive value of the sentinel lymph node in the determination of lymph node metastases in these patients. OUTLINE: This is a multicenter study. Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
Interventions
DRUGIsosulfan Blue
Undergo lymphangiography using isosulfan blue or methylene blue
PROCEDURELymph Node Mapping
Undergo lymphatic mapping
PROCEDURELymphangiography
Undergo lymphangiography using isosulfan blue or methylene blue
DRUGMethylene Blue
Undergo lymphangiography using isosulfan blue or methylene blue
PROCEDURERadionuclide Imaging
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
PROCEDURESentinel Lymph Node Biopsy
Undergo complete pelvic and low para-aortic lymphadenectomy
RADIATIONTechnetium Tc-99m Sulfur Colloid
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
PROCEDURETherapeutic Conventional Surgery
Undergo radical hysterectomy
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Diagnosis of carcinoma of the cervix of 1 of the following cellular types: * Squamous cell carcinoma * Adenocarcinoma * Adenosquamous cell carcinoma * Stage IB1 disease (no greater than 4 cm) * No unequivocal evidence of metastases * Adequate surgical candidate * No known allergy to triphenylmethane compounds * No prior pelvic irradiation * No prior retroperitoneal surgery * More than 4 weeks since prior cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy * Prior cone biopsy allowed provided current disease is stage IB1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | At the time of surgery | Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases. |
| False Negative Predictive Value (FNPV) | At the time of Surgery | The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases |
Countries
United States
Participant flow
Recruitment details
This trial was opened to patient entry on June 21, 2004 and was closed to entry July 21, 2008.
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid | 89 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible-Improper prior treatment | 2 |
| Overall Study | Ineligible-Inadequate pathology | 6 |
| Overall Study | Ineligible required test not done | 1 |
| Overall Study | Ineligible Wrong Cell type/primary/stage | 3 |
| Overall Study | Inevaluable (Never Treated) | 1 |
Baseline characteristics
| Characteristic | Diagnostic |
|---|---|
| Age, Customized 20-29 years | 6 Participants |
| Age, Customized 30-39 years | 23 Participants |
| Age, Customized 40-49 years | 31 Participants |
| Age, Customized 50-59 years | 17 Participants |
| Age, Customized 60-69 years | 9 Participants |
| Age, Customized 70-79 years | 2 Participants |
| Age, Customized 80-89 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 75 Participants |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 89 |
| other Total, other adverse events | 32 / 89 |
| serious Total, serious adverse events | 0 / 89 |
Outcome results
Primary
False Negative Predictive Value (FNPV)
The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases
Time frame: At the time of Surgery
Population: Eligible and evaluable patients who tested as negative sentinel node and have lymph node sampling
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic | False Negative Predictive Value (FNPV) | 5.9 Percentage of participants |
Primary
Sensitivity
Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.
Time frame: At the time of surgery
Population: Eligible and evaluable patients with lymph node metastasis and identified sentinel node
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic | Sensitivity | 85.7 Percentage of participants |