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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
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

Brief 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.

Detailed Summary:

OBJECTIVES:

Primary

• 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.

Secondary

• 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 regimens.

OUTLINE:

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.
• Ar
  Sponsor: Leiden University Medical Center
  

  Current Primary Outcome:

  • Overall survival [ Time Frame: 5 years ]
  • Failure-free survival [ Time Frame: 5 years ]
  
  
  

  Original Primary Outcome:

  • Overall survival at 5 years
  • Failure-free survival at 5 years
  
  
  

  Current Secondary Outcome:

  • Quality of life by QLQ-C30 v3.0 [ Time Frame: 5 years ]
  • Severe treatment-related morbidity [ Time Frame: 5 years ]
    Acute serious events and SAE and late grade 3 complications
  • Rate of vaginal or pelvic relapse [ Time Frame: 5 years ]
  • Rate of distant metastases [ Time Frame: 5 years ]
  
  
  

  Original Secondary Outcome:

  • Quality of life by QLQ-C30 v3.0
  • Severe treatment-related morbidity
  • Rate of vaginal or pelvic relapse
  • Rate of distant metastases
  
  
  Information By: Leiden University Medical Center
  

  Dates:
  Date Received: December 11, 2006
  Date Started: October 2006
  Date Completion: December 2020
  Last Updated: April 24, 2016
  Last Verified: April 2016