Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer

NCT00411138UNKNOWNPHASE3INTERVENTIONAL

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy together with radiation therapy is more effective than giving radiation therapy alone in treating endometrial cancer. PURPOSE: This randomized phase III trial is studying chemotherapy and radiation therapy to see how well they work compared with radiation therapy alone in treating patients with high-risk, stage I, stage II, or stage III endometrial cancer.

Key Facts

Lead Sponsor

Leiden University

Enrollment

670

Start Date

2006-11-23

Completion Date

2018-11-29

Study Type

INTERVENTIONAL

Official Title

Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy With Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma: PORTEC-3

Interventions

Radiation TherapycisplatincarboplatinPaclitaxel

Conditions

Endometrial Cancer

Eligibility

Age Range

18 Years – 90 Years

Sex

FEMALE

Inclusion Criteria:

* Histologically confirmed endometrial carcinoma, with one of the following postoperative FIGO 2009 stages and grade:

  1. stage IA with invasion, grade 3 with documented LVSI
  2. stage IB grade 3
  3. stage II
  4. stage IIIA or IIIC; or IIIB if parametrial invasion only
  5. stage IA (with invasion), IB, II, or III with serous or clear cell histology
* WHO-performance status 0-2
* WBC ≥ 3.0 x 109/L.
* Platelets ≥ 100 x 109/L.
* Bilirubin ≤ 1.5 x UNL
* ASAT/ALAT ≤ 2.5 x UNL
* Written informed consent

Exclusion criteria:

* Uterine sarcoma (including carcinosarcoma)
* Previous malignancy (except for non-melanomatous skin cancer) \< 10 yrs
* Previous pelvic radiotherapy
* Hormonal therapy or chemotherapy for this tumor
* Macroscopic stage II for which Wertheim type hysterectomy (eligible if stage II grade 3 or stage III at pathology)
* Prior diagnosis of Crohn's disease or ulcerative colitis
* Residual macroscopic tumor after surgery
* Creatinine clearance ≤ 60 ml/min (Cockroft) or ≤ 50 ml/min (EDTA clearance, or measured creatinine clearance)
* Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy
* Peripheral Neuropathy \> or = grade 2
* Hearing impairment \> or = grade 3, or born deaf

Outcome Measures

Primary Outcomes

Overall survival

co-primary endpoint

Time frame: 5 years

Failure-free survival

co-primary endpoint

Time frame: 5 years

Secondary Outcomes

Quality of life by QLQ-C30 v3.0

Health-related overall quality of life and patient-reported symptom measures

Time frame: 5 years

Severe treatment-related morbidity

Acute serious events and SAE and late grade 3-4 complications

Time frame: 5 years

Vaginal or pelvic relapse

Both vaginal or pelvic relapse as first failure and total vaginal or pelvic relapse

Time frame: 5 years

Distant metastases

Both distant relapse as first failure and total distant relapse

Time frame: 5 years

Locations

Leiden University Medical Center, Leiden, Netherlands

Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer