Endometrial Cancer Treatment Trials
| Clinical
Trial: |
LAP-2
-- Endometrial Adenocarcinoma and Uterine Sarcoma |
| Governing
Group: |
Gynecologic
Oncology Group |
| 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, Clincal
Stage I, IIA, Grade I, II, III." |
Eligibility:
-
Patients must have a diagnosis of endrometrial carcinoma or uterine
sarcoma with no clinical evidence of metastasis beyond the uterine
corpus or with macroscopic involvement of the endocervix.
-
Patients must have adequate bone marrow, renal and hepatic function.
Patient must be suitable candidate for surgery and have a GOG
performance status of 0, 1, 2 or 3.
-
Patients with a prior malignancy, but no current evidence of disease,
are eligible.
-
Patients cannot have had prior retroperitoneal surgery.
-
Patients can have no prior pelvic or abdominal radiation therapy.
-
Patients cannot be pregnant at time of diagnosis and have no contraindications
to laparoscopy.
-
Patients can have no evidence of metastasis on chest X-ray.
|
| Clinical
Trial: |
184
-- Advanced Endometrial Carcinoma |
| Governing
Group: |
Gynecologic
Oncology Group |
| Title: |
"A Randomized
Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic
Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin
and Paclitaxel for Advanced Endometrial Carcinoma." |
Eligibility:
-
All patients with advanced endometrial carcinoma, of any histology,
including clear cell and serous papillary carcinomas.
-
Surgically stagged III or IV disease, including those patients
with positive adnexa, tumor invading the serosa, positive pelvic
and/or para-aortic nodes, involvement of bowel mucosa, intra-abdominal
metastases, positive pelvic washings or vaginal involvement within
the radiation port.
-
Surgery must have included a hysterectomy and bilateral salpingo-oophorectomy.
Pelvic lymph node sampling and para-aortic lymph node sampling
are optional. Radiation will be initiated within six (6) weeks
after surgery and chemotherapy will be initiated within eight
(8) weeks after radiation.
-
Tumor must be maximally debulked to maximum residual diameter
of 2 cm or less.
-
All positive para-aortic node patients are to be further staged
by chest CT scan. If chest CT scan is negative, patients are eligible.
-
Adequate hematologic, renal and hepatic function.
-
Performance status of 0-3.
-
Disease free from other malignancies over 5 years.
-
Patients with disease outside the abdomen are ineligible.
-
No prior chemotherapy.
-
Patients with recurrent disease are ineligible.
|
| Clinical
Trial: |
S9630
-- Endometrial Pathology |
| Governing
Group: |
Southwest
Oncology Group |
| Title: |
"A Randomized
Comparison of Medroxyprogesterone Acetate and Observation for Prevention
of Endometrial Pathology in Postmenopausal Breast Cancer Patients
Treated With Tamoxifen." |
Eligibility:
-
Primary unilateral or bilateral invasive adenocarcinoma of the
breast, DCIS or LCIS with microinvasion.
-
No "pure" LCIS, sarcoma, lymphoma, apocrine, adenocystic or squamous
cell cancer of the breast.
-
No recurrent invasive breast cancer.
-
Prior, ongoing or planned adjuvant chemotherapy.
-
No prior hormonal treatment (other than tamoxifen) for breast
cancer.
-
Cannot be currently eligible or previously treated on any adjuvant
intergroup study.
-
Must have had definite local treatment of primary lesion and axillary
node sampling or sentinal node biopsy required unless DCIS or
LCIS as specified in protocol.
-
Patient must be candidate for tamoxifen, or ER and PgR unknown.
-
Tumor staged as T1-3, N0-1 and M0.
-
Currently free of disease, female, postmenopausal, no prior hysterectomy.
-
Must be registered within 28 days of Tamoxifen start date.
-
Endovaginal Sonogram due prior to registration.
|
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