Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer (PORTEC-3)
This study is currently recruiting participants.
Verified April 2012 by Leiden University Medical Center
Sponsor:
Leiden University Medical Center
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
ClinicalTrials.gov Identifier:
NCT00411138
First received: December 11, 2006
Last updated: April 11, 2012
Last verified: April 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Radiation: Radiation Therapy Drug: cisplatin Drug: carboplatin Drug: Paclitaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Leiden University Medical Center:
Primary Outcome Measures:
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Failure-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of life by QLQ-C30 v3.0 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Severe treatment-related morbidity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Acute serious events and SAE and late grade 3 complications
- Rate of vaginal or pelvic relapse [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Rate of distant metastases [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 670 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
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:
Drug: Paclitaxel
paclitaxel 175 mg/m2, 4 cycles after completion of radiotherapy, 3 wks interval
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders 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:
- stage IA with invasion, grade 3 with documented LVSI
- stage IB grade 3
- stage II
- stage IIIA or IIIC; or IIIB if parametrial invasion only
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411138
Contacts
| Contact: Carien Creutzberg, MD PhD | +31 71 526 5120 | c.l.creutzberg@lumc.nl |
| Contact: Karen Verhoeven-Adema, PhD | +31 71 526 3052 | k.w.adema@lumc.nl |
Locations
| Netherlands | |
| Leiden University Medical Center | Recruiting |
| Leiden, Netherlands, 2300 RC | |
| Contact: Carien L. Creutzberg, MD, PhD 31-71-526-5120 c.l.creutzberg@lumc.nl | |
| Contact: Karen W. Verhoeven-Adema +31-71-526-3052 k.w.adema@lumc.nl | |
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 |
More Information
Additional Information:
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, ISRCTN14387080, P06.031-PORTEC-3, 2007-004917-33 |
| Study First Received: | December 11, 2006 |
| Last Updated: | April 11, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by 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 Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors |
Neoplasms, Glandular and Epithelial Cisplatin Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013