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Rectal Cancer RecurrentPhase 2ReRad IINCT04695782

Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy

A Phase 2 study testing Pencil beam proton radiotherapy in people with Rectal Cancer Recurrent, run by University of Aarhus at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Study design: A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer. Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer Recurrent
What is being tested?
Pencil beam proton radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteDenmark
Study dates
10 Oct 2020to 31 Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • Locally recurrent rectal cancer.
  • Bioptically verified (adenocarcinoma )
  • Available dose plan from primary radiotherapy
  • Previous pelvic RT (>30Gy EQD2)
  • Evaluated in MDT-conferences (Herlev, Aarhus)
  • Age>18 years
Show all 9Show fewer
  • PS 0-2
  • Adequate organ function
  • Informed consent

Who cannot join

  • Non-resectable distant metastases (PET-CT)
  • Unable to undergo MRI, PET-CT
  • Inability to attend full course radiotherapy and follow up in the out patient clinic.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Camilla Kronborg, MD, PhD contact

+45 78450000

camkro@rm.dk

Denmark1 site, 1 recruiting

  • Danish Centre for Particle Therapy

    Aarhus, 8200

    Camilla Kronborg, MD, PhD

    Recruiting

Other trials in Denmark

About this study

Study design:

A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer.

Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.

Being tested
Pencil beam proton radiotherapy

What participants receive

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

  • Pencil beam proton radiotherapyRadiation

    Doseescalated pencil beam proton Therapy

Study groups in NCT04695782
Study groupRoleWhat they receive
Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two dailyExperimentalNot described
Receives: Radiation: Pencil beam proton radiotherapy
Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two dailyExperimentalNot described
Receives: Radiation: Pencil beam proton radiotherapy

What is being measured

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

  1. R0-resection

    Neo-adjuvant treatment: Rate of pathological complete resection (R0)

    Measured: 5-6 years

  2. 1-year local control

    Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.

    Measured: 6-7 years

Secondary outcomes (5)

  1. Local recurrence

    Local re-recurrence determined by imaging 6, 12 and 24 month post treatment

    Measured: 6-8 years

  2. Disease free survival

    Disease free survival, defined as time from first day of treatment until first documented sign of disease or death from any course

    Measured: 10 years

  3. Overall survival

    Overall survival defined as time from first day of treatment to death from any cause

    Measured: 10 years

  4. Toxicity

    Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic

    Measured: 5-7 years

  5. Patient reported outcomes

    Quality of life assessment by EORTC QLQ-c30, QLQ-CR29, supplementary EORTC items, and LARS score. Acute and chronic

    Measured: 5-7 year

Timeline

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

  1. First posted5 Jan 2021
  2. Study start10 Oct 2020
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Oct 2028 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04695782
Sponsor's protocol ID
DCPT221020
Acronym
ReRad II
Status last verified
Oct 2020
First submitted
4 Jan 2021
Last updated
5 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pencil beam proton radiotherapy in people with Rectal Cancer Recurrent, run by University of Aarhus at 1 site in Denmark.

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 9 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Jan 2021. 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 Denmark. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Camilla Kronborg, MD, PhD (+45 78450000, camkro@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0-resection (time frame: 5-6 years). The study lists 2 primary outcomes in all. 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 NCT04695782.

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 5 Jan 2021.

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