Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer (PORTEC-3)
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| ClinicalTrials.gov Identifier: NCT00411138 |
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Recruitment Status :
Active, not recruiting
First Posted : December 13, 2006
Last Update Posted : October 11, 2023
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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 |
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 : | November 29, 2018 |
| Estimated Study Completion Date : | December 31, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Radiation Therapy
Pelvic Radiotherapy alone
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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:
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Experimental: Radiation Therapy and Chemotherapy
Pelvic Radiation plus 2 concurrent cycles cisplatin followed by 4 adjuvant cycles carboplatin and paclitaxel
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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:
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- Overall survival [ Time Frame: 5 years ]co-primary endpoint
- Failure-free survival [ Time Frame: 5 years ]co-primary endpoint
- Quality of life by QLQ-C30 v3.0 [ Time Frame: 5 years ]Health-related overall quality of life and patient-reported symptom measures
- Severe treatment-related morbidity [ Time Frame: 5 years ]Acute serious events and SAE and late grade 3-4 complications
- Vaginal or pelvic relapse [ Time Frame: 5 years ]Both vaginal or pelvic relapse as first failure and total vaginal or pelvic relapse
- Distant metastases [ Time Frame: 5 years ]Both distant relapse as first failure and total distant relapse
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
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
| Netherlands | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 RC | |
| Study Chair: | Carien L. Creutzberg, MD, PhD | Leiden University Medical Center |
Publications of Results:
Other Publications:
| Responsible Party: | Carien Creutzberg, Chief Investigator, Leiden University |
| ClinicalTrials.gov Identifier: | NCT00411138 |
| 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: | October 11, 2023 |
| Last Verified: | October 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Sharing of data will be an option after publication of long-term outcomes and after submission of a research plan with is approved by the with international TMG |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Time Frame: | Anticipated in 218 |
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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 |
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Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Genital Diseases Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |