Clinical trial NCT02501954: Trial of Cisplatin Plus Radiation Followed by Carbo and Taxol Vs. Sandwich Therapy of Carbo and Taxol Followed Radiation Then Further Carbo and Taxol
Official title: Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Sandwich Therapy of Carboplatin and Paclitaxel Followed by Tumor Volume Directed Irradiation Then Further Carboplatin and Paclitaxel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Stage IIIA Uterine Corpus Cancer
Stage IIIB Uterine Corpus Cancer
Stage IIIC Uterine Corpus Cancer
Stage IVA Uterine Corpus Cancer
Lead sponsor: Women's Cancer Care Associates, LLC
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces the rate of recurrence when compared to sandwich therapy.

Detailed description: To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence (increases recurrence-free survival) when compared to sandwich therapy (control arm).

To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (increases survival) when compared to sandwich therapy (control arm).

To compare the regimens with respect to tolerability and acute and late adverse effects of therapy.

Eligibility criteria: Inclusion Criteria:

* All patients with Surgical Stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria, including clear cell and serous papillary and undifferentiated carcinomas.
* Surgical Stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement.
* Surgical Stage IVA includes patients with bladder or bowel mucosal involvement, but no spread outside the pelvis.
* Patients with FIGO 2009 surgical Stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology.
* Surgery must have included a hysterectomy and bilateral salpingooophorectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional.
* Patients with a GOG Performance Status of 0, 1, or 2.
* Patients with adequate organ function, reflected by the following parameters:

WBC ≥ 3000/mcl Absolute neutrophil count (ANC) ≥ 1500/mcl Platelet count ≥ 100,000/mcl SGOT, SGPT, and alkaline phosphatase ≤ 2.5 X upper limit of normal (ULN) Bilirubin ≤ 1.5 X ULN Creatinine ≤ institutional ULN

* Patients must be 18 years of age or older.
* Entry into the study is limited to no more than 8 weeks from the date of surgery.

Exclusion Criteria:

* Patients with carcinosarcoma.
* Patients with recurrent endometrial cancer.
* Patients with residual tumor after surgery (any single site) exceeding 1 cm in maximum dimension.
* Patients who have had pelvic or abdominal radiation therapy.
* Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma.
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
* Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy.
* Patients with an estimated survival of less than three months.
* Patients with FIGO 2009 Stage IVB endometrial cancer.
* Patients with parenchymal liver metastases.
* Patients who have received prior chemotherapy for endometrial cancer.
* Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment.

Primary outcomes:
measure: Recurrence-free survival (RFS)
timeFrame: From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: from study entry to death or date of last contact, assessed up to 8 years
Other outcomes:
measure: Incidence of acute and adverse effects as graded by the NCI Common Toxicity Criteria for Adverse Events version (CTCAE) version 4.0
timeFrame: From study entry through completion of study treatment, assessed for 1 year.
Locations:
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Traverse City
country: United States
facility: Munson Health Care
state: Michigan
city: Morristown
country: United States
facility: Atlantic Health
state: New Jersey
city: Albany
country: United States
facility: Women's Cancer Care Associates, LLC
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: La Crosse
country: United States
facility: Gunderson Lutheran Medical Foundation
state: Wisconsin
city: Montréal
country: Canada
facility: CHUM Hopital Notre-Dame
state: Quebec
Study officials:
affiliation: Women's Cancer Care Associates, LLC
name: Joyce N Barlin, MD
role: PRINCIPAL_INVESTIGATOR
References: