Endometrial cancer stage I-III radically operated with high-risk factors (high-grade and deep myometrial infiltration, or serous or clear cell histology) that will receive adjuvant treatment with radiotherapy.
Conditions
Interventions
Trade Name: AP (doxorubicin+cisplatin)
Pharmaceutical Form:
INN or Proposed INN: Doxorubicin
CAS Number: 23214-92-8
Other descriptive name: ATC L01D B01
INN or Proposed INN: Cisplatin
CAS Number: 156
Sponsors
Nordic Society for Gynecologic Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must have histologically proven endometrial cancer, of one of the fol-lowing types: - FIGO grade 3 or WHO poorly differentiated endometrioid adenocarcinoma (adenosquamous adenocarcinoma included) with infiltration ?50% of the myometrial thickness a. OR - >10% of the tumor consisting of serous carcinoma regardless of grade and differentiation OR - >10% of the tumor consisting of clear cell carcinoma regardless of grade and differentiation OR - Undifferentiated or anaplastic carcinoma 2. Patients must have an endometrial cancer in one of the following FIGO 1988 sur-gical stages b. - stage I b OR - stage II without macroscopic tumor involvement of the cervix at preopera-tive examination ("occult" stage II) OR - stage IIIA only because of positive peritoneal fluid cytology OR - stage IIIC only because of positive pelvic lymph nodes, but without post-operative macroscopic residual tumor. 3. Patients must be fit to receive combination chemotherapy. 4. Patients must have a WHO performance status of 0-2 and have an adequate bone marrow, renal, hepatic and pulmonary function. 5. Patient’s age >18 years 6. Patients must give informed consent according to the rules and regulations of the individual participating centers. a Swedish centers can also include patients with two of the three risk factors: grade, myome-trial infiltration, or non-diploidy. b Lymphadenectomy is not mandatory Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any macroscopic postoperative residual tumor. 2. Spread of disease on the surface or outside the uterus, except to macroscopically radically excised pelvic lymph nodes or positive peritoneal fluid cytology. 3. Macroscopic tumor involvement of the cervix at preoperative examination. 4. Para-aortic lymph node involvement. 5. Squamous carcinoma or small cell carcinoma with neuroendocrine differentiation. 6. Preoperative irradiation. 7. Previous or concurrent malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin. 8. Active infection or other serious underlying medical condition, which might pre-vent the patient from receiving treatment or to be followed 9. Uncontrolled or potentially active site of pelvic infection (e.g. fistula or ab-scesses). 10. Inadequate bone marrow, liver, or kidney function (WBC upper normal value, total S-bilirubin > 2 x upper normal value, estimated GFR <50 ml/min according to Cock-roft-Gault or Jeliffe for patients who will be treated with cisplatin. 11. Previous extensive abdominal surgery or other condition that might give a sub-stantial increase in the risk for complications from the radiation treatment or che-motherapy. 12. Whatever reasons which interferes with an adequate follow-up. 13. Longer interval than 7 weeks between surgery and randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the addition of adjuvant chemotherapy to the traditional treatment with pelvic radiation in patients with an endometrial primary cancer with histopathologic risk factors and FIGO 1988 surgical stage I or surgical stage II without macroscopic tumor involvement of the cervix at preoperative examination ("occult" stage II) or surgical stage IIIA because of positive cytology or surgical stage IIIC because of positive pelvic lymph nodes, but without postoperative macroscopic residual tumor. ;Secondary Objective: 1. To compare overall survival of patients treated with either radiation alone or ra-diation and chemotherapy given sequentially. 2. To evaluate the addition of chemotherapy to the standard adjuvant treatment (ra-diotherapy) in terms of toxicity. 3. To study whether the pattern of progression will be influenced by the addition of chemotherapy. ;Primary end point(s): Primary end-point: ? To compare progression-free survival of patients treated with either radiation alone or radiation and chemotherapy given sequentially | — |
Countries
Sweden
Outcome results
None listed