GOG 238: A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-only Recurrence of Carcinoma of the Uterine Corpus
This is a phase II, randomized, open-label trial of cisplatin and pelvic irradiation as second line therapy for subjects with uterine cancer. The primary endpoint of this study is PFS. Subjects will be assigned to WAR alone (4500cGy in 25 fractions plus interstitial or intracavitary brachytherapy or external beam boost) versus WAR and cisplatin (40 mg/m2/week). See revisions for doses in sections: 4.2342, 4.2344, and 4.244. The protocol target enrollment is 200 people; we plan to enroll 10 subjects at our sites.
1.All patients must have undergone complete hysterectomy and bilateral salpingooophorectomy at the time of the original therapy for their uterine carcinoma.
2.Patients must have a biopsy with histologically confirmed diagnosis of recurrent endometrial cancer confined to the pelvis and/or vagina and no evidence of extrapelvic disease.
3.Patients must have endometrial carcinoma including endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous adenocarcinoma, squamous cell carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and serous adenocarcinoma histologies.
4.Patients must have no evidence of extrapelvic disease. Complete workup staging should be performed prior to initiation of therapy to rule-out presence of metastatic disease. This should include: CT scan of the thorax with IV contrast, as well as a CT of the pelvis and abdomen with IV and PO contrast performed using multidetector CT and equal or less than 5 mm slice thickness. If the patient is unable to tolerate contrast, then MRI with IV gadolinium should be performed.
5.Primary surgical debulking before protocol therapy is permissible. This would include removal of gross symptomatic disease in the pelvis and/or vagina. Exenterative surgery is not permissible. Patients enrolled subsequent to revision 11 with complete resection of gross recurrent disease are eligible. (05/14/2012)
6.Patients may have received prior hormone therapy and/or systemic chemotherapy. Such therapy must have been completed at least 6 months prior to study entry and the patient has clear evidence of disease subsequent to such therapy. Patients must not have received neoadjuvant chemotherapy for the present recurrent disease.
7.Patients must have GOG performance status 0, 1, or 2.
8.Patients must have an estimated survival greater than or equal to 3 months
9.Patients must have adequate:
a.Bone Marrow Function: Absolute neutrophil count (ANC) ≥ 1,500/mm3, equivalent to Common Toxicity Criteria (CTCAE v 3.0) grade 1.
b.Platelets ≥ 100,000/mm3 (CTCAE v3.0 grade 0-1).
c.Renal Function: Creatinine ≤ institutional upper limit normal (ULN), CTCAE v 3.0 grade 0. Note: If creatinine > ULN, creatinine clearance must be >50 mL/min.
d.Hepatic Function: Bilirubin ≤ 1.5 x ULN (CTCAE v3.0 grade 1). SGOT and alkaline phosphatase ≤ 2.5 x ULN (CTCAE v3.0 grade 0-1).
e.Neurologic Function: Neuropathy (sensory and motor) ≤ CTCAE v3.0 grade 1.
10.Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry.
11.Patients who have met the pre-entry requirements specified in Section 7.0.
12.Patients must have signed an approved informed consent and HIPAA authorization.
13.Spanish-speaking subjects are eligible for enrollment.