Rectal CancerTNT-RECORDNCT05883800
Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer
A study testing On-couch adaptive radiotherapy in people with Rectal Cancer, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- On-couch adaptive radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteNorway
- Study dates
- 22 Jun 2023to 31 Dec 2031
- Phase
- Interventional
- 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
- Patients with loco-regional advanced rectal adenocarcinoma with clinical indications for short-course with TNT chemotherapy i.e. having at least one of the following T4a, CRM+ (≤1 mm), N1c, N2 or extramural vascular invasion (EMVI+). Patients presenting at least one of these criteria in addition to involvement of the pelvic sidewall lymph nodes (PSW) can optionally be considered.
- ECOG status ≤ 1
- Being willing and able to give full written consent for participation
Who cannot join
- Previous rectal cancer treatment
- Previous irradiation to the treatment area e.g. prostate cancer
- Hip prosthesis
- Contraindications to MRI
- Pregnancy
- Abnormal DPYD genotype
- Known contraindication to 5-FU, Capecitabine or Oxaliplatin as judged by the investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5021
About this study
Official title: TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy
Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment).
This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.
Read the detailed description
This is a prospective single-arm study investigating the benefit of on-couch adaptation for locally advanced rectal cancer patients prescribed with pre-operative sequential short-course radiotherapy (RT) followed by Oxaliplatin-combined chemotherapy (mFOLFOX(6) or CAPOX). On-couch adaptation, where the radiation dose is tailored to the anatomy of the patient at each radiotherapy session. Firstly, the study will investigate if on-couch adaptation result in less gastro-intestinal adverse events, secondly it will reveal if this possible reduction lead to more patients being able to fulfill all cycles of prescribed chemotherapy.
- Conditions
- Rectal Cancer
- Being tested
- On-couch adaptive radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-couch adaptive radiotherapyRadiation
Also called online ART
A new treatment plan, guided by volumetric images, is created at each treatment session
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention: daily on-couch adaptive radiotherapy Receives: Radiation: On-couch adaptive radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute gastro-intestinal toxicity equal or higher than grade 2
Incidence of acute gastro-intestinal toxicity from therapy graded according to CTCAE ver. 5.
Measured: Up to administration of the last course of chemotherapy or week 22, whichever comes first
Secondary outcomes (6)
Number of participants that require alteration of chemotherapy due to toxicity
Alterations of chemotherapy, defined as dose-reduction or pre-maturely stopping chemotherapy administration
Measured: From treatment week 3 up to week 20
Number of patients with disease related treatment failure
Disease-related treatment failure include the first of any of the following events:
(i) During treatment: Non-radical resection of primary tumor (R2 resection) or un-fit of for surgery due to progression, death from treatment (ii) During, or after treatment: Loco-regional recurrence (including regrowth after potential watch-and-wait), distant metastasis (including M re-staging at surgery), death from rectal cancer, second primary rectal cancer.
Measured: 5 years after surgery
Number of patients with pathological complete response (pCR)
pCR after completion of the intended or tolerated TNT
Measured: At surgery i.e. in treatment week 23-28
Tumour regression grade
Radiological based clinical response evaluation on MR (mrTRG)
Measured: Baseline to response evaluation on MR in up to week 25 of the study
Overall survival
Overall survival from time of inclusion until death
Measured: Follow-up until 5 years or death
Incidence of late gastro-intestinal toxicity equal or higher than grade 2
Incidence of late gastro-intestinal events (e.g.diarrhea, rectal hemorrhage, rectal and/or abdominal pain) from therapy graded according to CTCAE ver. 5.
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 posted1 Jun 2023
- Study start22 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
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 Haukeland 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Unn Hege Lilleøren, MD, Principal investigator, Dept. of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883800
- Sponsor's protocol ID
- 402056
- Acronym
- TNT-RECORD
- Status last verified
- Jul 2023
- First submitted
- 24 Feb 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy
- ClinicalTrials.gov ID
- NCT05883800
- Acronym / sponsor ID
- TNT-RECORD / 402056
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 1 Jun 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.
Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment).
This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.
Detailed description
This is a prospective single-arm study investigating the benefit of on-couch adaptation for locally advanced rectal cancer patients prescribed with pre-operative sequential short-course radiotherapy (RT) followed by Oxaliplatin-combined chemotherapy (mFOLFOX(6) or CAPOX). On-couch adaptation, where the radiation dose is tailored to the anatomy of the patient at each radiotherapy session. Firstly, the study will investigate if on-couch adaptation result in less gastro-intestinal adverse events, secondly it will reveal if this possible reduction lead to more patients being able to fulfill all cycles of prescribed chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Radiation: On-couch adaptive radiotherapyIntervention: daily on-couch adaptive radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with loco-regional advanced rectal adenocarcinoma with clinical indications for short-course with TNT chemotherapy i.e. having at least one of the following T4a, CRM+ (≤1 mm), N1c, N2 or extramural vascular invasion (EMVI+). Patients presenting at least one of these criteria in addition to involvement of the pelvic sidewall lymph nodes (PSW) can optionally be considered.
- ECOG status ≤ 1
- Being willing and able to give full written consent for participation
Key exclusion criteria (7 listed)
- Previous rectal cancer treatment
- Previous irradiation to the treatment area e.g. prostate cancer
- Hip prosthesis
- Contraindications to MRI
- Pregnancy
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 |
|---|---|---|
| On-couch adaptive radiotherapyAlso: online ARTA new treatment plan, guided by volumetric images, is created at each treatment session | Radiation | Intervention |
Primary outcome
Incidence of acute gastro-intestinal toxicity equal or higher than grade 2
Time frame: Up to administration of the last course of chemotherapy or week 22, whichever comes first
Incidence of acute gastro-intestinal toxicity from therapy graded according to CTCAE ver. 5.
6 secondary outcomes
Number of participants that require alteration of chemotherapy due to toxicity
Time frame: From treatment week 3 up to week 20
Number of patients with disease related treatment failure
Time frame: 5 years after surgery
Number of patients with pathological complete response (pCR)
Time frame: At surgery i.e. in treatment week 23-28
Tumour regression grade
Time frame: Baseline to response evaluation on MR in up to week 25 of the study
Overall survival
Time frame: Follow-up until 5 years or death
Incidence of late gastro-intestinal toxicity equal or higher than grade 2
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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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.
Unn Hege Lilleøren, MD principal investigator
Dept. of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-couch adaptive radiotherapy in people with Rectal Cancer, run by Haukeland University Hospital at 1 site in Norway.
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 3 inclusion and 7 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 19 Mar 2024. 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 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.
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 Sara Pilskog, PhD (95890659 ext. 0047, sara.margareta.cecilia.pilskog@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute gastro-intestinal toxicity equal or higher than grade 2 (time frame: Up to administration of the last course of chemotherapy or week 22, whichever comes first). 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 19 Mar 2024.