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Uterine Cervical NeoplasmsAPROVENCT03184350

Adjuvant Protontherapy of Cervical and Endometrial Carcinomas

A study testing Adjuvant pelvic proton radiation in people with Uterine Cervical Neoplasms and Endometrial Neoplasms Malignant, run by Heidelberg University at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The APROVE study is a prospective single-center single-arm phase-II study. Patients with cervical or endometrial cancer after surgical resection who have an indication for postoperative pelvic radiotherapy will be treated with proton therapy instead of the commonly used photon radiation. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
What is being tested?
Adjuvant pelvic proton radiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteGermany
Study dates
Jun 2017to Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

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 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed cervical or endometrial cancer
  • Indication for postoperative radiotherapy
  • Karnofsky Index ≥ 70
  • Age between 18 and 80 years
  • Written informed consent

Who cannot join

  • patient refusal or patient incapable of consent
  • implanted active medical devices with no approval for ion beam radiation
  • metallic implantations in the radiation field like hip prothesis
  • prior pelvic irradiation
  • participation in another clinical trial which might influence the results of the APROVE trial

Trial locations and contacts

1 site in 1 country.

Nathalie Arians, MD contact

+496221568202

nathalie.arians@med.uni-heidelberg.de

Karen Lossner contact

+4962215637748

karen.lossner@med.uni-heidelberg.de

Germany1 site, 1 recruiting

  • Department of radiation oncology, University Hospital Heidelberg

    Heidelberg, 69120

    Nathalie Arians, MD, +496221568202, nathalie.arians@med.uni-heidelberg.de

    Karen Lossner, +4962215637748, karen.lossner@med.uni-heidelberg.de

    Recruiting

Other trials in Germany

About this study

Official title: Adjuvant Protontherapy of Cervical and Endometrial Carcinomas - A Phase-II-study

The APROVE study is a prospective single-center single-arm phase-II study. Patients with cervical or endometrial cancer after surgical resection who have an indication for postoperative pelvic radiotherapy will be treated with proton therapy instead of the commonly used photon radiation. A total of 25 patients will be included in this trial. Patients will receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered if indicated. The primary endpoint of the study is the evaluation of safety and treatment tolerability of pelvic radiation using protons defined as the lack of any CTC AE Grade 3 or 4 toxicity. Secondary endpoints are clinical symptoms and toxicity, quality of life and progression-free survival. The aim is to explore the potential of proton therapy as a new method for adjuvant pelvic radiotherapy to decrease the dose to the bowel, rectum and bladder thus reducing acute and chronic toxicity and improving quality of life.

Being tested
Adjuvant pelvic proton radiation
Keywords
cervical cancer, endometrial cancer, proton therapy
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvant pelvic proton radiationRadiation

    Patients will receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active raster-scanning pencil beam proton radiation

Study groups in NCT03184350
Study groupRoleWhat they receive
Adjuvant pelvic proton radiationOtherNot described
Receives: Radiation: Adjuvant pelvic proton radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of acute treatment-associated adverse events ≥ grade 3 [Safety and Tolerability]

    Assessment of toxicity according to the CTC AE v4.0 (Common Toxicity Criteria for adverse events)

    Measured: 3 months

Secondary outcomes (5)

  1. clinical symptoms according to the CTC AE v4.0. criteria

    clinical symptoms of any grade will be assessed

    Measured: 2 years

  2. Quality of life of all patients included in the study

    assessed by the EORTC questionnaires QLQ-C30

    Measured: 2 years

  3. Quality of life of cervical cancer patients included in the study

    assessed by the EORTC questionnaires QLQ-CX24

    Measured: 2 years

  4. Quality of life of endometrial cancer patients included in the study

    assessed by the EORTC questionnaires QLQ-EN24

    Measured: 2 years

  5. Progression-free survival

    regular MRI-scans

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2017
  2. Study startJun 2017 (estimated)
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Patients will receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered if indicated. For treatment planning rectum, sigma, large and small bowel, bladder and femoral heads are defined as organs at risk. The CTV is defined according to the EORTC consensus guidelines. Treatment-associated toxicity and Quality of life will be evaluated regularly.
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03184350
Sponsor's protocol ID
APROVE
Acronym
APROVE
Status last verified
Jun 2017
First submitted
9 Jun 2017
Last updated
12 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meixner E, Wark A, Forster T, Weykamp F, Lang K, Konig L, Lindel K, Oelmann-Avendano JT, Krisam J, Schneeweiss A, Ellerbrock M, Mielke T, Horner-Rieber J, Herfarth K, Debus J, Arians N. Health-related quality of life and patient-reported symptoms after postoperative proton beam radiotherapy of cervical and endometrial cancer: 2-year results of the prospective phase II APROVE-trial. Radiat Oncol. 2023 Jan 9;18(1):5. doi: 10.1186/s13014-023-02198-4.

    PubMed 36624483

  • Arians N, Lindel K, Krisam J, Herfarth K, Krug D, Akbaba S, Oelmann-Avendano J, Debus J. Prospective phase-II-study evaluating postoperative radiotherapy of cervical and endometrial cancer patients using protons - the APROVE-trial. Radiat Oncol. 2017 Nov 28;12(1):188. doi: 10.1186/s13014-017-0926-5.

    PubMed 29179751

Questions about this trial

What is this clinical trial studying?

A study testing Adjuvant pelvic proton radiation in people with Uterine Cervical Neoplasms and Endometrial Neoplasms Malignant, run by Heidelberg University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nathalie Arians, MD (+496221568202, nathalie.arians@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of acute treatment-associated adverse events ≥ grade 3 [Safety and Tolerability] (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03184350, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.

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