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

Phase 3
18 Years
90 Years
Open (Enrolling)
Endometrial Cancer

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Trial Information

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



- Compare the overall survival and failure-free survival of patients with high-risk stage
IB-III endometrial carcinoma treated with concurrent chemoradiotherapy followed by
adjuvant chemotherapy vs pelvic radiotherapy alone.


- Compare the rates of pelvic and distant recurrence, severe (grades 3 and 4)
treatment-related toxicity, and quality of life of patients treated with these


This is a multicenter, prospective, open-label, randomized, controlled study. Patients are
stratified according to participating group (DGOG vs UK NCRI vs NCIC CTG vs MaNGO vs
Unicancer), type of surgery (total abdominal hysterectomy and bilateral
salpingo-oophorectomy [TAH-BSO] vs TAH-BSO plus lymphadenectomy vs laparoscopic hysterectomy
[TLH-BSO] vs TLH-BSO plus lymphadenectomy), stage (IA vs IB vs II vs III), and histological
type (endometrioid carcinoma vs serous or clear cell carcinoma). Patients are randomized to
1 of 2 treatment arms.

- Arm I: Patients receive external-beam pelvic radiotherapy 5 days a week for up to 6
weeks, combined with cisplatin IV days 1 and 22. Patients with cervical involvement
undergo vaginal brachytherapy boost. At least 3 weeks after completion of
chemoradiotherapy, patients undergo adjuvant chemotherapy comprising paclitaxel IV and
carboplatin IV on day 1. Adjuvant chemotherapy repeats every 3 weeks for up to 4
courses in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients undergo external-beam pelvic radiotherapy (and vaginal brachytherapy
alone in case of cervical involvement) as in arm I.

Quality of life is assessed at baseline, completion of radiotherapy, completion of
chemotherapy, at 6 months, and then once a year for 5 years.

After completion of study therapy, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Carien L. Creutzberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Leiden University Medical Center


Netherlands: Medical Ethics Review Committee (METC)

Study ID:

CDR0000521447; P06.031



Start Date:

October 2006

Completion Date:

December 2018

Related Keywords:

  • Endometrial Cancer
  • endometrial clear cell carcinoma
  • stage II endometrial carcinoma
  • stage IA grade 3 endometrial carcinoma
  • stage IB endometrial carcinoma
  • stage IIIA endometrial carcinoma
  • stage IIIB endometrial carcinoma
  • stage IIIC endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma