MDACC Study Summary GOG LAP2 (Archived)

Study Summary
No. GOG LAP2:.......Cervix; Endometrium; Sarcoma; Uterus; Vagina......Pedro Ramirez......Gynecologic Oncology

Study Summary Title



Study Summary Number:	GOG LAP2

Study Title:	A Phase III Randomized Clinical Trial of Laparoscopic Pelvic and Para-Aortic Node Sampling with Vaginal Hysterectomy and BSO versus Open Laparotomy with Pelvic and Para-Aortic Node Sampling and Abdominal Hysterectomy and BSO in Endometrial Adenocarcinoma and Uterine Sarcoma, Clinical Stage I, IIA, Grade I, II, III

Physician

New Patient Referral



Name:	Pedro Ramirez	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:	713-745-5498 Contact us about clinical trials

General Information



Disease Group:	Cervix Endometrium Sarcoma Uterus Vagina	Supported By:	GOG

Phase of Study:	Phase III	Return Visit:	Post-surgery: 1 week, 3 weeks, 6 weeks, 6 months; then every 3 months for 2 years and every 6 months for 3 years.

Treatment Agents:	Laparoscopy Laparotomy Surgery	Home Care:	None

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

Estimated Length of Stay in Houston:	2 to 6 days depending on procedure to which participant is randomized


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

To compare the incidence of surgical complications, peri-operative morbidity and mortality which occurs with surgical staging via either laparoscopic assisted vaginal hysterectomy or a total abdominal hysterectomy in patients with clinical stage I or IIa endometrial cancer.

To compare the lengths of hospital stay following surgery for these patients staged with these two surgical procedures.

To compare post-operative self assessed quality of life scores in patients staged with these two surgical techniques.

To compare the incidence of subcutaneous abdominal recurrences in these patients staged with these two techniques.

Study Status Information



Study Activation / Registration Date:	04/15/2003

IRB Review and Approval Date:	04/02/2003

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	2550

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) Patients with endometrial adenocarcinoma or sarcoma with no clinical evidence of metastasis beyond the uterine corpus or with macroscopic involvement of the endocervix.

2) Patients with adequate bone marrow, renal and hepatic function: WBC >/= 3,000 cells/mcl Platelets >/= 100,000/mcl Creatinine </= 2.0 mg% Bilirubin </= 1.5 x normal and SGOT </= 3 x normal

3) GOG Performance Status of 0, 1, 2, or 3. Patients must be suitable candidates for surgery.

4) Patients who have signed an approved Informed Consent.

5) Patients who have met the pre-entry requirements specified in Section 7.0 of the protocol.

6) Patients who speak English, Canadian French and Spanish will be able to participate in the quality of life portion of this study. Any patient who does not speak these languages is still eligible to participate in the surgical component.

7) Patients with a prior malignancy with no current evidence of disease.

Exclusion Criteria:

1) Patients who have had prior retroperitoneal surgery.

2) Patients who have received prior pelvic or abdoninal radiation therapy.

3) Patients who are pregnant.

4) Patients with contraindications to laparoscopy.

5) Patients with evidence of metastasis on chest x-ray.

Links

Registration Number: NCT00002706
Study Information on Clinical Trials Registry (clinicaltrials.gov)