Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Carcinoma

Adenocarcinoma

Carcinoma, Squamous Cell

Carcinoma, Adenosquamous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Methylene Blue

Technetium Tc 99m Sulfur Colloid

Enzyme Inhibitors

Radiopharmaceuticals

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.

Undergo lymphangiography using isosulfan blue or methylene blue

Isosulfan Blue

Lymph Node Mapping

Lymphangiography

Undergo radionuclide imaging with technetium Tc 99m sulfur colloid

Radionuclide Imaging

Undergo complete pelvic and low para-aortic lymphadenectomy

Sentinel Lymph Node Biopsy

Technetium Tc-99m Sulfur Colloid

Therapeutic Conventional Surgery

Charles Levenback

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.

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.

Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer

Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma

Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.

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

National Cancer Institute (NCI)

Gynecologic Oncology Group

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

Diagnostic

20-29 years

30-39 years

40-49 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Linda Gedeon for Wei Deng, PhD.

Eligible and evaluable patients with lymph node metastasis and identified sentinel node

Sensitivity

Eligible and evaluable patients who tested as negative sentinel node and have lymph node sampling

False Negative Predictive Value (FNPV)

Radionuclide and Isosulfan Blue Injection

Overall Study

Symptoms and General Pathology

Recurrence

Fluorodeoxyglucose F18

biopsy

computed tomography

positron emission tomography

fludeoxyglucose F 18

Steven M. Larson, MD

RATIONALE: New imaging procedures such as fludeoxyglucose F 18 PET scan may improve the ability to detect cancer or recurrence of cancer.

PURPOSE: Clinical trial to study the effectiveness of fludeoxyglucose F 18 PET scan in diagnosing primary or recurrent cervical cancer in patients who are undergoing surgery.

OBJECTIVES:

* Assess the feasibility of using fludeoxyglucose F 18 (FDG) positron emission tomography (PET) imaging in patients with primary or recurrent cervical cancer.
* Investigate the ability of FDG-PET scan imaging to detect lymph node metastases in these patients.
* Investigate the ability of FDG-PET imaging to identify locally advanced disease in early stage cervical cancers.
* Compare FDG-PET to CT scan imaging with respect to distinguishing between postradiation pelvic fibrosis and recurrent cervical cancer.
* Investigate the ability of FDG-PET to identify recurrent cervical cancer.

OUTLINE: This is a diagnostic study.

Patients with primary cervical cancer receive fludeoxyglucose F 18 (FDG) intravenously followed 45 minutes later with positron emission tomography (PET) imaging over 60 minutes, as well as computed tomography (CT) scan. Both diagnostic imaging techniques are to assess the abdomen and pelvis, and must be done within 2 weeks prior to surgery. Patients eligible for surgery undergo radical hysterectomy and lymphadenectomy and all specimens are evaluated for correlation with the preoperative diagnostic tests findings.

Patients with recurrent cervical cancer obtain FDG-PET scan and CT scan of the thorax, abdomen, and pelvis prior to surgical exploration for pelvic exenteration. All biopsy specimens are evaluated for correlation with diagnostic tests findings.

PROJECTED ACCRUAL: A total of 30 patients (20 patients with primary cervical cancer and 10 patients with recurrent cervical cancer) will be accrued for this study.

PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery

A Pilot Study of 18F-Flourodeoxyglucose Positron Emission Tomography in the Diagnosis of Primary and Recurrent Cervical Cancer

Memorial Sloan Kettering Cancer Center

Gland and Hormone Related Diseases

Nervous System Diseases

Substance Related Disorders

Rare Diseases

Sarcoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Neurotoxicity Syndromes

Endometrial Neoplasms

Fallopian Tube Neoplasms

Syndrome

Adnexal Diseases

Neoplasms, Connective and Soft Tissue

Fallopian Tube Diseases

Poisoning

Chemically-Induced Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Fallopian Tube Cancer

Uterine Sarcoma

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Amifostine

Tubulin Modulators

Antimitotic Agents

Protective Agents

Radiation-Protective Agents

amifostine trihydrate

cisplatin

paclitaxel

David H. Moore, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of amifostine in reducing the risk of side effects caused by cisplatin and paclitaxel in treating women who have ovarian, peritoneal, cervical, fallopian tube, uterine, or endometrial cancer.

OBJECTIVES: I. Determine the efficacy of amifostine in reducing significant peripheral neuropathy in women with ovarian, peritoneal, cervical, fallopian tube, uterine, or endometrial cancer treated with cisplatin and paclitaxel. II. Determine the proportion of patients on this regimen who experience significant peripheral neuropathy 3 months after completing chemotherapy. III. Assess the overall toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours, amifostine IV over 10 minutes, and cisplatin IV over 90 minutes. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Neurotoxicity is assessed and vibration perception threshold testing is performed prior to each course of chemotherapy and at 3 months following the last treatment. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 29-59 patients will be accrued for this study within 18-36 months.

Amifostine in Treating Women With Ovarian, Peritoneal, Cervical, Fallopian Tube, Uterine, or Endometrial Cancer

A Limited Access Trial Using Amifostine for Protection Against Cisplatin and 3-Hour Paclitaxel-Induced Neurotoxicity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer	NCT00070317	Cervical Adenoc... Cervical Adenos... Cervical Squamo... Stage I Cervica...	Isosulfan Blue Lymph Node Mapp... Lymphangiograph... Methylene Blue Radionuclide Im... Sentinel Lymph ... Technetium Tc-9... Therapeutic Con...	-	GOG Foundation
PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery	NCT00003429	Cervical Cancer	biopsy computed tomogr... positron emissi... fludeoxyglucose...	18 Years - 120 Years	Memorial Sloan Kettering Cancer Center
Amifostine in Treating Women With Ovarian, Peritoneal, Cervical, Fallopian Tube, Uterine, or Endometrial Cancer	NCT00003624	Cervical Cancer Endometrial Can... Fallopian Tube ... Neurotoxicity Ovarian Cancer Primary Periton... Sarcoma	amifostine trih... cisplatin paclitaxel	-	GOG Foundation
Amifostine in Treating Women With Ovarian, Peritoneal, Cervical, Fallopian Tube, Uterine, or Endometrial Cancer	NCT00003624	Cervical Cancer Endometrial Can... Fallopian Tube ... Neurotoxicity Ovarian Cancer Primary Periton... Sarcoma	amifostine trih... cisplatin paclitaxel	-	GOG Foundation
PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery	NCT00003429	Cervical Cancer	biopsy computed tomogr... positron emissi... fludeoxyglucose...	18 Years - 120 Years	Memorial Sloan Kettering Cancer Center
PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery	NCT00003429	Cervical Cancer	biopsy computed tomogr... positron emissi... fludeoxyglucose...	18 Years - 120 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for stage i cervical cancer