A randomized trial of adjuvant treatment with radiation plus chemotherapy versus radiation alone in high-risk endometrial carcinoma NSGO-EC-9501 Amendment 2.

• Conditions: 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.

• Registration Number: EUCTR2004-002429-37-SE
• Lead Sponsor: ordic Society for Gynecologic Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 400

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

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 <3.5x109/L, neutrophils < 1.5x109/L, platelets <100x109/L S-creatinine > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified