ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer (PORTEC-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00411138
Recruitment Status : Active, not recruiting
First Posted : December 13, 2006
Last Update Posted : February 28, 2018
Sponsor:
Collaborators:
Cancer Research UK
Australia New Zealand Gynaecological Oncology Group
NCIC Clinical Trials Group
Mario Negri Institute for Pharmacological Research
UNICANCER
Information provided by (Responsible Party):
Carien Creutzberg, Leiden University Medical Center

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.


Condition or disease Intervention/treatment Phase
Endometrial Cancer Radiation: Radiation Therapy Drug: cisplatin Drug: carboplatin Drug: Paclitaxel Phase 3

Detailed Description:

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.
  • 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 23, 2006
Actual Primary Completion Date : April 1, 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Radiation Therapy
Pelvic Radiotherapy alone
Radiation: Radiation Therapy
External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions) Vaginal brachytherapy boost in case of cervical involvement
Other Names:
  • RT
  • 3D conformal radiotherapy
  • IMRT
  • brachytherapy
Experimental: Radiation Therapy and Chemotherapy
Pelvic Radiation plus 2 concurrent cycles cisplatin followed by 4 adjuvant cycles carboplatin and paclitaxel
Radiation: Radiation Therapy
External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions) Vaginal brachytherapy boost in case of cervical involvement
Other Names:
  • RT
  • 3D conformal radiotherapy
  • IMRT
  • brachytherapy
Drug: cisplatin
cisplatin 50 mg/m2 i.v., 2 cycles during radiotherapy, 3 wks interval
Other Name: Cisplatine
Drug: carboplatin
carboplatin AUC 5, 4 cycles after completion of radiotherapy, 3 wks interval
Other Names:
  • Carboplatine
  • Carbotaxol
Drug: Paclitaxel
paclitaxel 175 mg/m2, 4 cycles after completion of radiotherapy, 3 wks interval
Other Names:
  • Taxol
  • Taxolcarbo



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    co-primary endpoint

  2. Failure-free survival [ Time Frame: 5 years ]
    co-primary endpoint


Secondary Outcome Measures :
  1. Quality of life by QLQ-C30 v3.0 [ Time Frame: 5 years ]
    Health-related overall quality of life and patient-reported symptom measures

  2. Severe treatment-related morbidity [ Time Frame: 5 years ]
    Acute serious events and SAE and late grade 3-4 complications

  3. Vaginal or pelvic relapse [ Time Frame: 5 years ]
    Both vaginal or pelvic relapse as first failure and total vaginal or pelvic relapse

  4. Distant metastases [ Time Frame: 5 years ]
    Both distant relapse as first failure and total distant relapse



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411138


Locations
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Sponsors and Collaborators
Leiden University Medical Center
Cancer Research UK
Australia New Zealand Gynaecological Oncology Group
NCIC Clinical Trials Group
Mario Negri Institute for Pharmacological Research
UNICANCER
Investigators
Study Chair: Carien L. Creutzberg, MD, PhD Leiden University Medical Center

Additional Information:
Publications of Results:

Other Publications:
Responsible Party: Carien Creutzberg, Chief Investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00411138     History of Changes
Other Study ID Numbers: CDR0000521447; P06.031
CKTO-2006-04 ( Other Grant/Funding Number: Dutch Cancer Society )
ISRCTN14387080 ( Registry Identifier: International Standard Randomised Controlled Trial Number )
P06.031-PORTEC-3 ( Other Identifier: Leiden University Medical Center )
2007-004917-33 ( EudraCT Number )
First Posted: December 13, 2006    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Will be decided with international participating groups at time of final analysis

Keywords provided by Carien Creutzberg, Leiden University Medical Center:
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

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action