MDACC Study Summary 2008-0118

Study Summary
No. 2008-0118:.......Cervix......Kathleen Schmeler......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2008-0118

Study Title:	Conservative surgery for women with low-risk, early stage cervical cancer

Physician

New Patient Referral



Name:	Kathleen Schmeler	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3518 Contact us about clinical trials

General Information



Disease Group:	Cervix	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients are seen q3 mos (+/- 4 wks) beginning after their postop visit with PE/pelvic/pap smear X2 yrs. If abnormalities are detected, patients will be treated at discretion of their physician. After 2 years, patients will be contacted yearly X3.

Treatment Agents:	Surgical Procedure	Home Care:	Not Applicable

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Length of stay dependent on surgery (laparascopic, robotic or open). Range 1-7 days.


Description/ Intervention:	The goal of this surgical research study is to learn if "conservative surgery" is a safe and feasible option for women with low-risk cervical cancer (stage IA2 or IB1, Grade 1 or 2).

Study Objectives / Outcomes

Primary Objective

1. To evaluate the safety and feasibility of performing conservative surgery in women with stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features

Secondary Objectives

1. To estimate the cervix cancer recurrence rate at 2 years in women treated with conservative surgery for stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features

2. To compare pelvic lymph node involvement in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy

3. To estimate the sensitivity of sentinel lymph node biopsy in the determination of pelvic lymph node metastases in this group of patients

4. To compare the treatment-associated morbidity in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy

5. To assess quality of life factors, sexual functioning, symptoms and satisfaction with healthcare decisions in this group of patients

Study Status Information



Study Activation / Registration Date:	08/25/2009

IRB Review and Approval Date:	08/25/2009

Study Type:	Other

Recruitment Status:	Open

Projected Accrual:	100

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Squamous cell carcinoma of the cervix (any grade) or histologically confirmed grade 1 or 2 adenocarcinoma of cervix

2) FIGO stage IA2 or IB1 disease

3) Tumor diameter </= 2 cm on physical exam & imaging studies (if performed)

4) No lymphovascular space invasion present on biopsy or previous cone

5) Cone margins & ECC specimen negative for invasive cancer, CIN 2, CIN3 or adenocarcinoma-in-situ (1 repeat cone/ECC permitted)

6) Patients eligible for study if Cone and ECC was performed prior to enrollment in study, provided the above pathologic eligibility criteria are met & cone/ECC was performed within 12 wks of enrollment

7) Patients must sign approved ICD

8) If patient is of childbearing potential, must have a negative blood or urine pregnancy test prior to surgery.

9) Patients who have had a simple hysterectomy (cut-through hysterectomy) prior to enrollment are eligible, provided the above pathology criteria are met. If lymphadenectomy was performed the lymph nodes must be negative. If lymphadenectomy was not performed, patients will undergo this procedure as part of the study.

10) Less than 10mm of cervical stromal invasion

Exclusion Criteria:

1) Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk histologies

2) Grade 3 adenocarcinoma

3) FIGO stage IA1, IB2, II, III or IV disease

4) Tumors >2 cm in diameter on physical exam or imaging studies (if performed)

5) Presence of LVSI

6) Cone margins or ECC specimen positive for invasive cancer, CIN2, CIN3 or adenocarcinoma-in-situ (one repeat cone permitted)

7) Neoadjuvant radiation therapy or chemotherapy for cervical cancer

8) Patients unwilling or unable to provide informed consent for the study

9) Greater than or equal to 10mm of cervical stromal invasion

Links

Registration Number: NCT01048853
Study Information on Clinical Trials Registry (clinicaltrials.gov)