Endometrial AdenocarcinomaPETRECNCT05655260
PErsonalized TReatment for Endometrial Carcinoma
A study testing Comparison of chemotherapy vs. chemoradiotherapy and Comparison of VBT vs. WPRT in people with Endometrial Adenocarcinoma, run by University of Helsinki at 1 site in Finland.
Trial summary
The goal of this clinical trial is to compare the efficacy of adjuvant therapies in women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. Specifically, the invesigators want to compare: Chemotherapy vs. chemoradiotherapy in p53 abn subtype and nonendometrioid carcinomas. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Endometrial Adenocarcinoma
- What is being tested?
- Comparison of chemotherapy vs. chemoradiotherapy and Comparison of VBT vs. WPRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- 8 Feb 2022to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 100 years
- WHO performance status 0 to 2
- Stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma
Who cannot join
- Age <18 years or >100 years
- WHO performance status >2
- Uterine sarcoma
- A history of malignancy within 5 years
- Previous pelvic radiotherapy
- An interval of >30 days between surgery and start of chemotherapy or >8 weeks between surgery and start of radiotherapy (longer intervals may be permitted with investigator´s approval)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, 00290
Mikko Loukovaara, MD, +358504272526, mikko.loukovaara@hus.fi
Ralf Bützow, MD, +358504271899, ralf.butzow@hus.fi
About this study
The goal of this clinical trial is to compare the efficacy of adjuvant therapies in women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. Specifically, the invesigators want to compare:
- Chemotherapy vs. chemoradiotherapy in p53 abn subtype and nonendometrioid carcinomas.
- Vaginal brachytherapy vs. whole pelvic radiotherapy in the MMR-D molecular subgroup.
- Vaginal brachytherapy vs. whole pelvic radiotherapy in the NSMP molecular subgroup.
Read the detailed description
Endometrial carcinomas can be classified into four molecular subgroups, i.e. mismatch repair deficient (MMR-D), p53 abnormal (p53 abn), polymerase-ϵ (POLE) ultramutated, and "no specific molecular profile" (NSMP). Molecular subgroups can be considered to be distinct diseases as they are associated with different clinicopathologic characteristics, prognoses and, possibly, responses to adjuvant therapy. Molecular classification of endometrial carcinoma is recommended to be implemented in routine clinical practice to improve prognostication and triage to adjuvant therapy. The PErsonalized TReatment for Endometrial Carcinoma (PETREC) trial, led by the Finnish Gynecologic Oncology Group (FINGOG), is a multicenter prospective clinical trial for women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. The efficacy of chemotherapy vs. chemoradiotherapy is compared in p53 abn subtype and nonendometrioid carcinomas, and vaginal brachytherapy vs. whole pelvic radiotherapy in MMR-D and NSMP molecular subgroups. Patients who consent to follow-up within the trial but not to randomization are treated as recommended in multidisciplinary meetings and enrolled for follow-up only (comprehensive cohort study design). The primary outcome is the 5-year cumulative incidence of disease recurrence. Secondary outcomes are vaginal, pelvic, and distant recurrence rates, 5-year recurrence-free and overall survival, adverse events, and patient-reported symptoms and quality of life. The findings of the trial may eventually help decrease under- and overtreatment and, consequently, improve patient outcome and decrease treatment-associated adverse effects.
- Conditions
- Endometrial Adenocarcinoma
- Being tested
- Comparison of chemotherapy vs. chemoradiotherapy, Comparison of VBT vs. WPRT
- Keywords
- Endometrial carcinoma, Molecular classification, Adjuvant therapy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of chemotherapy vs. chemoradiotherapyOther
Chemotherapy (paclitaxel-carboplatin) vs. chemoradiotherapy (paclitaxel-carboplatin followed by whole pelvic radiotherapy)
Patients assigned to chemotherapy receive paclitaxel (175 mg/m2) and carboplatin (area under curve, 5) every 3 weeks for 6 cycles. The pelvic radiotherapy dose is 45 to 50.4 Gy over 5 to 6 weeks (1.8 Gy per day for 25 to 28 fractions).
Comparison of VBT vs. WPRTOther
Vaginal brachytherapy vs. whole pelvic radiotherapy
Patients randomized to vaginal brachytherapy receive cuff brachytherapy at 21 Gy in 3 fractions of 7 Gy at 0.5 cm depth. The pelvic radiotherapy dose is 45 to 50.4 Gy over 5 to 6 weeks (1.8 Gy per day for 25 to 28 fractions).
| Study group | Role | What they receive |
|---|---|---|
| p53 abn subtype and nonendometrioid carcinomas | Experimental | p53 abn stage I-II MI (myometrial invasion) >0%; MMR-D/NSMP nonendometrioid stage I-II MI >0% Receives: Other: Comparison of chemotherapy vs. chemoradiotherapy |
| MMR-D molecular subgroup | Experimental | MMR-D stage IA-B grade 1-2, substantial LVSI; MMR-D stage IA grade 3, substantial LVSI; MMR-D stage IB grade 3; MMR-D stage II grade 1-3; Receives: Other: Comparison of VBT vs. WPRT |
| NSMP molecular subgroup | Experimental | NSMP stage IA-B grade 1-2, substantial LVSI; NSMP stage IA grade 3, substantial LVSI; NSMP stage IB grade 3; NSMP stage II grade 1-3; Receives: Other: Comparison of VBT vs. WPRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer reappearance
Cumulative incidence of disease recurrence
Measured: 5 years
Secondary outcomes (4)
Location of cancer reappearance
Vaginal, pelvic, and distant recurrence rates
Measured: 5 years
Overall survival
The time from surgery to death
Measured: 5 years
Recurrence-free survival
The time from surgery to cancer recurrence
Measured: 5 years
Adverse events
Adjuvant therapy-related adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start8 Feb 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comprehensive cohort design
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital, Kymenlaakso Central Hospital Kotka Finland, Päijänne Tavastia Central Hospital, South Carelia Central Hospital
- Responsible party
- Principal investigator, Mikko Loukovaara, University of Helsinki
- Investigators
- Mikko Loukovaara, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655260
- Sponsor's protocol ID
- HUS/2360/2021
- Acronym
- PETREC
- Status last verified
- Dec 2024
- First submitted
- 30 Nov 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loukovaara M, Butzow R, Staff S, Maenpaa M, Faltinova M, Lassus H, Veijalainen O, Gronvall M, Vaalavirta L, Kuikka E, Haataja M, Urpilainen E, Simojoki M, Anttila M, Auranen A. PErsonalized TReatment for Endometrial Carcinoma (PETREC): study design and methods of a prospective Finnish multicenter trial. Int J Gynecol Cancer. 2023 Nov 6;33(11):1807-1811. doi: 10.1136/ijgc-2023-004939.
PubMed 37813479