A phase II Trial of postoperative chemotherapy or no further treatment for patients with node-negative stage I-II intermediate or high risk endometrial cancer
The goal of this clinical research study is to learn if chemotherapy (carboplatin and paclitaxel) after surgery for endometrial cancer is better than surgery alone.
Disease Group: Gynecology
Treatment Agent: Carboplatin,Paclitaxel
Treatment Location: Both at MDACC & and Other Sites
Primary end-point The primary endpoint is overall survival in the subgroup of endometrioid adenocarcinoma. Secondary end-points Overall survival of whole study population Descriptive analysis of overall survival in non-endometroid adenocarcinoma Disease Specific Survival (DSS) Progression-Free Survival (PFS) Toxicity (both acute and late) Compliance Quality of Life (QOL) and symptom control will be assessed using European Organization for Research and Treatment of Cancer quality of life questionnaires (EORTC QLQ-C30 and EORTC-QLQ-EN24) Rate of isolated pelvic relapse (central or pelvic wall) Rate of isolated distant relapse Rate of mix local and distant relapse Objectives of Translational Sub-Study: To evaluate the prognostic and predictive values of tumor biomarkers from tissue collected at the initial surgery for the clinical outcome to chemotherapy or observation (eg. PFS and OS). To evaluate the prognostic and predictive values of tumor biomarkers from tissue collected at the initial surgery for certain parameters measured prior to/at study entry, such as a) relation to stage and grade of the disease and b) presence of certain toxicities to chemotherapy. To evaluate protein expression using immunohistochemical (IHC), and to analyze the obtained results with the purpose to develop a optimal classifier for selecting patients into sub-group for individual treatment strategies. To evaluate prognostic or predictive markers, such as epidermal growth factor receptor (EGFR), Kirsten rat sarcoma viral oncogene homolog (KRAS), v-raf murine sarcoma viral oncogene homology B1( BRAF), Neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS), Phosphatidylinositol 3-kinase (PIK3CA), phosphatase and tensin homolog(PTEN), tumor protein p53 (TP53) and F-box and WD repeat domain containing 7, E3 ubiquitin protein ligase (FBXW7) with the purpose of a optimal characterization of patients with the purpose of future individual treatment strategies. The Translational Research Steering Committee keeps the freedom to change the translational research (TR) if new developments indicate more useful research can be done on these samples.
IRB Review and Approval Date: 11/20/2014
Recruitment Status: Open
Projected Accrual: 240
1) Only node-negative patients are eligible. Histological confirmed
endometrial carcinoma with no macroscopic remaining tumor after primary
surgery and lymph node negative disease, with one of the following
post-operative International Federation of Gynecology and Obstetrics
(FIGO) 2009 stage and grade: a) Stage I grade 3 endometrioid
adenocarcinoma; b) Stage II endometrioid adenocarcinoma; c) Stage I and
II type 2 histology (clear cell, serous, squamous cell carcinoma,
carcinosarcoma or undifferentiated carcinoma)
2) Patients have undergone hysterectomy (total abdominal hysterectomy, radical hyste-rectomy, laparoscopic or robotic hysterectomy) and bilateral salpingo-oopherectomy (BSO) and pelvic lymphadenectomy (LNE).
3) Pelvic Lymphadenectomy (LNE): minimum 10 pelvic nodes (a minimum of 4 from each side) should be removed. Para-aortic LNE is optional
4) Patients who undergo sentinel lymphe node biopsy (SLB) may be included if the surgeon performing the SLB has performed at least 20 cases of SLB for endometrial cancer. In addition, for each patient, bilateral sentinel node must be identified or a side-specific pelvic lymphadenectomy must be performed if a SLN is not identified in a hemi-pelvis.
5) Omentectomy strongly recommended in clear cell, serous or undifferentiated carcinoma.
6) Surgery performed within 12 weeks of randomization. If the dates for hysterectomy and lymph node dissection are different, 12 weeks are counted from the last surgery, and in that case the gap between two surgeries should not exceed 8 weeks.
7) Patients must give informed consent according to the rules and regulations of the individual participating centers
8) Patients have not received any other anticancer therapy other than surgery for endometrial cancer.
9) Adjuvant vaginal brachytherapy is permitted in both arms. In chemotherapy arm, timing of vaginal brachytherapy (VBT) should not cause delay in chemotherapy delivery.
10) Patients must have a world health organization (WHO) performance status of 0-2
11) Patients must have an adequate bone-marrow, renal and hepatic function (WBC >/=3.0x109/L, neutrophils >/=1.5x109/L, platelets >/=100x109/L, total S-bilirubin <2 x upper normal value, ALAT <2.5 x upper normal value, estimated GFR >50 ml/min (measured or calculated according to Crockroft Gault, Jeliffe or Wright formula). Up to 5% deviation for hematological values and 10% deviation for s-bilirubin and ALAT are tolerated.
12) Life expectancy of at least 12 weeks
13) Patients must be fit to receive combination chemotherapy
14) Patient’s age >/=18 years
1) Sarcomas or small cell carcinoma with neuroendocrine differentiation.
2) External Beam Radiotherapy
3) Concurrent cancer therapy
4) Concurrent treatment with an anticancer investigational agent or participation in another anticancer clinical trial
5) Previous or concurrent malignant disease except for patients with second malignancy who has been relapse free for >/= 3 years, or patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
6) Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed
7) Whatever reasons which interferes with an adequate follow-up
8) Patients who are breast feeding must stop breast feeding before enrollment in the trial and must not do so during the whole trial period, otherwise these patients are non-eligible
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