aparoscopic Approach to Cervical Carcinoma

Phase 3

Recruiting

• Conditions: Cervical Cancer; Cancer - Cervical (cervix)

• Registration Number: ACTRN12608000019303
• Lead Sponsor: M.D Anderson Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 740

Inclusion Criteria

1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
2. Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (with lymph vascular space invasion), IA2, or IB1 disease;
3. Patients undergoing either a Type II or III radical hysterectomy (Piver Classification)
4. Patients with adequate bone marrow, renal and hepatic function:
4.1 White Blood Cells (WBC) > 3,000 cells/mcl
4.2 Platelets >100,000/mcl
4.3 Creatinine <2.0 mg/dL (Non-Isotope dilution mass spectrometry (non – IDMS))
4.4 Bilirubin <1.5 x normal and Serum Glutamic Oxaloacetic Transaminase (SGOT) or Serum Glutamic Pyruvic Transaminase (SGPT) <3 x normal
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
6. Patient must be suitable candidates for surgery;
7. Patients who have signed an approved Informed Consent;
8. Patients with a prior malignancy allowed if > 5 years previous with no current evidence of disease;
9. Females, aged 18 years or older.
10. Negative serum pregnancy test within 30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause

Exclusion Criteria

1. Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
2. Tumor size greater than 4 cm;
3. FIGO stage II-IV;
4. Patients with a history of pelvic or abdominal radiotherapy;
5. Patients who are pregnant;
6. Patients with contraindications to surgery;
7. Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes 8. Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
9. Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
10. Patient compliance and geographic proximity that do not allow adequate follow-up.
11. Patients who agree to intra-operative lymphatic mapping (IOLM) must not have: - Known allergies to triphenylmethane compounds. - History of retroperitoneal surgery. - History of pelvic irradiation. - Cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy within 4 wks of enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified