Utility of Preoperative FDG-PET/CT Prior to Primary Chemoradiation Therapy
to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally
Advanced Carcinoma of the Cervix (IB2, IIA =4 CM, IIB-IVA) or Endometrium
(Grade 3 Endometrioid Endometrial Carcinoma; Serous Papillary Carcinoma, Clear
Cell Carcinoma, or Carcinosarcoma (Any Grade); and Grade 1 or 2 Endometrioid
Endometrial Carcinoma With Cervical Stromal Involvement Overt in Clinical
Examination or Confirmed by Endocervical Curettage)
Protocol Documents
Protocol-GOG-0233/ACRIN 6671 Amendment 8, 10.23.09 (effective 11.16.09) [PDF]
SOC-GOG-0233/ACRIN 6671 Amendments 7 & 8, 10.23.09 (effective 11.16.09) [PDF]
Informed Consent-GOG 0233/ACRIN 6671 [DOC]
Principal Investigator: Mostafa Atri, MD, ACRIN Principal Investigator
Michael Gold, MD, GOG Study Chair
Status: Open
Primary Objectives:
- To evaluate the diagnostic sensitivity and specificity of preoperative FDG-PET/CT imaging in identifying metastases to abdominal (common iliac, para-aortic, and para-caval) lymph nodes in patients with locoregionally advanced cervical carcinoma.
- To evaluate the diagnostic sensitivity and specificity of preoperative FDG-PET/CT imaging in identifying metastases to retroperitoneal abdominal lymph nodes in patients with high-risk endometrial carcinoma.
Participants: Participating women must have either: primary, previously untreated, histologically confirmed, locoregionally advanced (IB2, IIA ≥4cm, IIB-IVA) invasive carcinoma of the cervix (any cell type)AND must be appropriate surgical candidates to undergo extra-peritoneal or laparoscopic lymph node sampling OR histologically confirmed Grade 3 endometrioid or non-endometrioid endometrial carcinoma (clear cell or serous papillary) or carcinosarcoma as diagnosed from an endometrial biopsy or dilation and curettage or histologically confirmed Grade 1 or 2 endometrioid endometrial carcinoma with cervical stromal involvement overt on clinical examination or confirmed by endocervical curettage AND must be appropriate surgical candidates to undergo hysterectomy and lymph node sampling.