Rectal CancerPhase 2Re-RAD-INCT05816980
Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients
A Phase 2 study testing Hyperfractionated external beam radiation in people with Rectal Cancer and Recurrence, run by Aarhus University Hospital at 2 sites in 2 countries.
Trial summary
This study investigates the potential benefit of re-irradiation of patients with locally advanced rectal recurrences, by a prospective phase II clinical, imaging and translational research study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Recurrence, Radiation Toxicity
- What is being tested?
- Hyperfractionated external beam radiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2015to Jan 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally recurrent rectal cancer
- Previous pelvic RT for rectal cancer and surgery
- Potentially resectable by MRI and palpation by MDT evaluation
- Absence of non-resectable distant metastases by PET-CT
- Age ≥ 18
- Adequate organ function
- Acceptable bowel and bladder function
- Acceptance for TR sampling
Who cannot join
- Central small recurrences deemed immediate resectable
- Previous radiotherapy <12 month prior to recurrence
- Non-resectable systemic or regional disease
- Unable to undergo MRI or PET-CT
- Medical comorbidities precluding radical surgery
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: External Beam Radiotherapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
This study investigates the potential benefit of re-irradiation of patients with locally advanced rectal recurrences, by a prospective phase II clinical, imaging and translational research study.
Read the detailed description
The overall purpose of this trial is to evaluate the efficacy of re-irradiation of patients with locally advanced rectal cancer (LRRC) recurrences who previously received pelvic irradiation. Patients with potentially resectable LRRC will be treated with hyperfractionated Intensity-Modulated Radiotherapy consisting of 40.8 Gy in 1.2 fractions twice daily with concomitant oral capecitabine followed by surgery, when feasible.
- Conditions
- Rectal Cancer, Recurrence, Radiation Toxicity
- Being tested
- Hyperfractionated external beam radiation
- Medical subject headings
- Rectal Neoplasms, Recurrence, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperfractionated external beam radiationRadiation
40.8Gy/34 fractions (1.2Gy BID 5/7 days with minimum 6 hours interval) Concurrent capecitabine (825 mg/m2 BID 5/7 days)
| Study group | Role | What they receive |
|---|---|---|
| Single | Other | Re-irradiation consisting of hyperfractionated IMRT, 40.8 Gy in 1.2 fractions twice daily 5/7 days weekly, with oral capecitabine 825 mg/m2 BID on radiotherapy treatment days. Re-staging performed 4-6 weeks after the last dose, followed by surgery, when feasible. Receives: Radiation: Hyperfractionated external beam radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection rate
Rate of complete pathological resection R0
Measured: At surgery
Secondary outcomes (5)
Physician reported Toxicity
Clinical and laboratory AEs (Adverse Events) will be graded according to NCICTCAE (version 4.0).
Measured: Acute and late toxicity evaluations during and at 6,12 and 36 months post surgery
QoL assessment according to QLQ-CR29
Assesment of QoL according to EORTC guidelines. The EORTC QLQ-CR29 is a tumor-specific health related QoL questionnaire module for CRC patients. Patients are asked to indicate their symptoms during the past week(s). According to EORTC guidelines, scores can be reported as frequencies of raw scores or scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Measured: Pre-treatment and 12 months post surgery
QoL assessment according to EORTC QLQ-C30
Assesment of QoL according to EORTC guidelines. The EORTC QLQ-CR30 is a general health related QoL questionnaire. Patients are asked to indicate their symptoms during the past week(s). According to EORTC guidelines, scores can be reported as frequencies of raw scores or scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Measured: Pre-treatment and 12 months post surgery
Recurrence rate
Rate of re-recurrence
Measured: Rate of re-recurrence at 6, 12 and 36 months post surgery.
Comparative dose planning study
Potential organ at risk sparing when comparing photons vs protons - comparative dose planning
Measured: The VMAT plans generated before treatment start (baseline) is compared to IMPT plans.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startJan 2015
- Primary completionJan 2019
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients are enrolled according to protocol criteria for hyperfractionated IMRT re-irradiation.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Karen-Lise Garm Spindler, Aarhus University Hospital
- Investigators
- Karen-Lise G Spindler, MD, Phd, Principal investigator, Aarhus University Hospital, Depart. Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816980
- Sponsor's protocol ID
- KFE-1506
- Acronym
- Re-RAD-I
- Status last verified
- Apr 2023
- First submitted
- 24 Oct 2016
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: IPDs will not be available to other researchers according to National General data protection regulations. However, data will be published according to guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Beam Radiotherapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
- ClinicalTrials.gov ID
- NCT05816980
- Acronym / sponsor ID
- Re-RAD-I / KFE-1506
- Conditions
- Rectal Cancer, Recurrence, Radiation Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the potential benefit of re-irradiation of patients with locally advanced rectal recurrences, by a prospective phase II clinical, imaging and translational research study.
Detailed description
The overall purpose of this trial is to evaluate the efficacy of re-irradiation of patients with locally advanced rectal cancer (LRRC) recurrences who previously received pelvic irradiation. Patients with potentially resectable LRRC will be treated with hyperfractionated Intensity-Modulated Radiotherapy consisting of 40.8 Gy in 1.2 fractions twice daily with concomitant oral capecitabine followed by surgery, when feasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients are enrolled according to protocol criteria for hyperfractionated IMRT re-irradiation.
| Arm | Type | Receives |
|---|---|---|
| Single | Other | Radiation: Hyperfractionated external beam radiationRe-irradiation consisting of hyperfractionated IMRT, 40.8 Gy in 1.2 fractions twice daily 5/7 days weekly, with oral capecitabine 825 mg/m2 BID on radiotherapy treatment days. Re-staging performed 4-6 weeks after the last dose, followed by surgery, when feasible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Locally recurrent rectal cancer
- Previous pelvic RT for rectal cancer and surgery
- Potentially resectable by MRI and palpation by MDT evaluation
- Absence of non-resectable distant metastases by PET-CT
- Age ≥ 18
Key exclusion criteria (5 listed)
- Central small recurrences deemed immediate resectable
- Previous radiotherapy <12 month prior to recurrence
- Non-resectable systemic or regional disease
- Unable to undergo MRI or PET-CT
- Medical comorbidities precluding radical surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperfractionated external beam radiation40.8Gy/34 fractions (1.2Gy BID 5/7 days with minimum 6 hours interval) Concurrent capecitabine (825 mg/m2 BID 5/7 days) | Radiation | Single |
Primary outcome
Resection rate
Time frame: At surgery
Rate of complete pathological resection R0
5 secondary outcomes
Physician reported Toxicity
Time frame: Acute and late toxicity evaluations during and at 6,12 and 36 months post surgery
QoL assessment according to QLQ-CR29
Time frame: Pre-treatment and 12 months post surgery
QoL assessment according to EORTC QLQ-C30
Time frame: Pre-treatment and 12 months post surgery
Recurrence rate
Time frame: Rate of re-recurrence at 6, 12 and 36 months post surgery.
Comparative dose planning study
Time frame: The VMAT plans generated before treatment start (baseline) is compared to IMPT plans.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No. IPDs will not be available to other researchers according to National General data protection regulations. However, data will be published according to guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen-Lise G Spindler, MD, Phd principal investigator
Aarhus University Hospital, Depart. Oncology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperfractionated external beam radiation in people with Rectal Cancer and Recurrence, run by Aarhus University Hospital at 2 sites in 2 countries.
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 8 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: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resection rate (time frame: At surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.