Rectal CancerCORRECTNCT06501053
Contact Radiotherapy for Rectal Cancer
A study testing Radiotherapy, Short-course radiotherapy and Contact x-ray brachytherapy in people with Rectal Cancer, run by Alexander Valdman at 2 sites in Sweden.
Trial summary
The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1). 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?
- Radiotherapy, Short-course radiotherapy and Contact x-ray brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesSweden
- Study dates
- 3 Mar 2025to Nov 2032
- 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
- Adenocarcinoma of the rectum classified as:
- cT1-cT3ab, < 5 cm largest diameter and < ½ circumference (MRI staging), N0-N1 (<= 3 nodes < 8mm diameter), M0
- Performance status (ECOG) 0-1
- Operable patient
- Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm
- 18 years or above
Show all 9Show fewer
- No comorbidity preventing treatment
- Patient having read the information note and having signed the informed consent
- Follow-up possible
Who cannot join
- Inoperable patient
- T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference
- Distance from the lower tumor border to the anal verge >10 cm
- N2-status at diagnosis or N1 with any node>= 8 mm diameter
- Patient presenting with metastasis at diagnosis (M1)
- Previous pelvic irradiation
Show all 16Show fewer
- Tumor with extramural vascular invasion
- Poorly differentiated tumor
- Simultaneous progressive cancer
- Tumor invading external anal sphincter or growth within 1 mm of the levator
- Tumor within 1 mm from MRF (mesorectal fascia)
- Patient unable to receive CXB or CRT
- Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy
- Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol
- Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
- Total DPD deficiency
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer
Stockholm, Solna, 171 76
Per J Nilsson, MD, PhD, +46 724 69 48 14, per.j.nilsson@regionstockholm.se
Per J Nilsson, MD, PhD
- Recruiting
Uppsala University Hospital, Colorectal Surgery
Uppsala, 751 85
Joakim Folkesson, MD, PhD, +46 18 611 00 00, joakim.folkesson@akademiska.se
About this study
Official title: Contact Radiotherapy for Rectal Cancer (CORRECT): a Multicenter Randomized Phase II Trial
The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).
Read the detailed description
The primary aim of this study is to determine whether a combination of CXB + SCRT is non-inferior to CXB + chemoradiotherapy (CRT) regarding the primary endpoint 2-year organ preservation rate. Additionally, we hypothesize that a chemotherapy-free, radiation-only experimental treatment CXB+SCRT is associated with less side-effects compared to the OPERA regime.
In the OPERA trial (Gerard et al, 2023), the CXB was delivered in combination with long-course CRT. A combination of short-course radiotherapy (SCRT) and CXB has previously been used mainly in elderly and comorbid patients not suitable for long-course chemoradiotherapy. Recently, an international multi-institution report showed good outcomes of planned organ preservation using SCRT together with contact brachytherapy boost. However, no randomized data on this combination therapy are available. There are further no trials comparing CRT+CXB and SCRT+CXB.
Study participants will be randomized to either the standard treatment consisting of CXB (90Gy/3 fractions/4 weeks) and CRT 45/50 Gy (1.8/2 Gy/fraction/5 weeks) with concurrent chemotherapy using capecitabine (900 mg/m2 bid, on radiation days) OR the experimental treatment consisting of CXB (90Gy/3 fractions/4 weeks) SCRT (25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days).
- Conditions
- Rectal Cancer
- Being tested
- Radiotherapy, Short-course radiotherapy, Contact x-ray brachytherapy, Chemotherapy
- Keywords
- organ sparing, brachytherapy, radiotherapy, nonoperative
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
45/50 Gy (1.8/2 Gy/fraction/5 weeks)
Short-course radiotherapyRadiation
25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days
Contact x-ray brachytherapyRadiation
90Gy/3 fractions/4 weeks
ChemotherapyDrug
Capecitabine (900 mg/m2 bid, on radiation days)
| Study group | Role | What they receive |
|---|---|---|
| CXB + CRT | Active comparator | Contact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and chemoradiotherapy (CRT) 45/50 Gy (1.8/2 Gy/fraction/5 weeks) with concurrent chemotherapy using capecitabine (900 mg/m2 bid, on radiation days). Receives: Radiation: Radiotherapy; Radiation: Contact x-ray brachytherapy; Drug: Chemotherapy |
| CXB + SCRT | Experimental | Contact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and a short-course radiotherapy (SCRT) (25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days). Receives: Radiation: Short-course radiotherapy; Radiation: Contact x-ray brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectum preservation
Proportion of patients with successful rectum preservation after standard vs experimental treatment. Organ preservation is considered to have failed if the rectum is removed OR if the patient develops non-salvageable locoregional failure
Measured: At 24 months after start of treatment
Secondary outcomes (15)
Acute treatment-related toxicity
Incidence of grade 3-5 toxicity as assessed by CTCAE v5.0
Measured: From start of treatment until 90 days after ending treatment
Late treatment related toxicity
Incidence of grade 3-5 toxicity as assessed by CTCAE v5.0
Measured: From 90 days after ending treatment until end of study
Clinical complete response (cCR)
Proportion of patients with cCR as assessed by DRE, endoscopy, MRI-T2W, and MRI-DWI
Measured: At 14-16 and 24-26 weeks after start of treatment
Postoperative complications
Difference in postoperative complications (graded according to Clavien-Dindo) after standard vs experimental treatment
Measured: Within the first 30 days after Total Mesorectal Excision (TME) surgery
Stoma
Proportion of patients with a stoma
Measured: At 12 and 24 months after start of treatment
Metastasis-free survival
Survival without sign of metastasis after standard vs experimental treatment
Measured: At 24 months after start of treatment
Locoregional failure
Proportion of patients with locoregional failure after standard vs experimental treatment
Measured: At 24 months after start of treatment
Overall survival
Overall survival after standard vs experimental treatment
Measured: At 24 months after start of treatment
TME-free survival
Survival without Total Mesorectal Excision after standard vs experimental treatment
Measured: At 24 months after start of treatment
Salvage TME resections
Rate of R0 Total Mesorectal Excisions after standard vs experimental treatment
Measured: From 24 weeks after start of treatment until end of study
Tumor regression grade
Tumor regression grade in the surgical specimen (R0, ypT0, ypTNM) after standard vs experimental treatment
Measured: After 14-16 weeks and 24-26 weeks after start of treatment
Sphincter preservation
Rate of sphincter preservation after standard vs experimental treatment
Measured: At 24 months after start of treatment
General Health Related Quality of Life (HR QoL)
General Health Related Quality of Life (HR QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire QLQ-C30. Responses made on a Likert scale are transformed to a score from 0 to 100 where a higher score indicate a better quality of life
Measured: At baseline and at 3, 6, 12, 24, 36, 48 and 60 months after start of treatment
Colorectal cancer specific Health Related Quality of Life (HR QoL)
Health Related Quality of Life (HR QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) colorectal cancer specific quality of life questionnaire QLQ-CR29. Responses made on a Likert scale are transformed to a score from 0 to 100 where a higher score indicate a better quality of life
Measured: At baseline and at 3, 6, 12, 24, 36, 48 and 60 months after start of treatment
Bowel function
Bowel function as assessed by the Low Anterior Resection Syndrome (LARS) score. LARS is scored from 0 to 42 points and a higher score indicates worse outcome.
Measured: At baseline, 3, 6, 12, 24, 36, 48 and 60 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start3 Mar 2025
- Primary completionApr 2030 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexander Valdman
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, Karolinska Institutet
- Responsible party
- Sponsor-investigator, Alexander Valdman, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501053
- Sponsor's protocol ID
- CORRECT
- Acronym
- CORRECT
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data that underlie the reported results.
Publications
Gerard JP, Barbet N, Schiappa R, Magne N, Martel I, Mineur L, Deberne M, Zilli T, Dhadda A, Myint AS; ICONE group. Neoadjuvant chemoradiotherapy with radiation dose escalation with contact x-ray brachytherapy boost or external beam radiotherapy boost for organ preservation in early cT2-cT3 rectal adenocarcinoma (OPERA): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):356-367. doi: 10.1016/S2468-1253(22)00392-2. Epub 2023 Feb 16.
PubMed 36801007Nilsson PJ, Folkesson J, Marsk R, Radu C, Stratulat I, Blomqvist L, Martling A, Valdman A. Contact radiotherapy for rectal cancer (CORRECT): study protocol for a multicentre randomised phase II trial. BMJ Open. 2025 Apr 9;15(4):e100356. doi: 10.1136/bmjopen-2025-100356.
PubMed 40204311
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Radiotherapy for Rectal Cancer (CORRECT): a Multicenter Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT06501053
- Acronym / sponsor ID
- CORRECT / CORRECT
- Conditions
- Rectal Cancer
- Keywords
- organ sparing, brachytherapy, radiotherapy, nonoperative
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Alexander ValdmanUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, Karolinska Institutet
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 15 Jul 2024 (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.
The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).
Detailed description
The primary aim of this study is to determine whether a combination of CXB + SCRT is non-inferior to CXB + chemoradiotherapy (CRT) regarding the primary endpoint 2-year organ preservation rate. Additionally, we hypothesize that a chemotherapy-free, radiation-only experimental treatment CXB+SCRT is associated with less side-effects compared to the OPERA regime.
In the OPERA trial (Gerard et al, 2023), the CXB was delivered in combination with long-course CRT. A combination of short-course radiotherapy (SCRT) and CXB has previously been used mainly in elderly and comorbid patients not suitable for long-course chemoradiotherapy. Recently, an international multi-institution report showed good outcomes of planned organ preservation using SCRT together with contact brachytherapy boost. However, no randomized data on this combination therapy are available. There are further no trials comparing CRT+CXB and SCRT+CXB.
Study participants will be randomized to either the standard treatment consisting of CXB (90Gy/3 fractions/4 weeks) and CRT 45/50 Gy (1.8/2 Gy/fraction/5 weeks) with concurrent chemotherapy using capecitabine (900 mg/m2 bid, on radiation days) OR the experimental treatment consisting of CXB (90Gy/3 fractions/4 weeks) SCRT (25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CXB + CRT | Active comparator | Radiation: Radiotherapy, Radiation: Contact x-ray brachytherapy, Drug: ChemotherapyContact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and chemoradiotherapy (CRT) 45/50 Gy (1.8/2 Gy/fraction/5 weeks) with concurrent chemotherapy using capecitabine (900 mg/m2 bid, on radiation days). |
| CXB + SCRT | Experimental | Radiation: Short-course radiotherapy, Radiation: Contact x-ray brachytherapyContact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and a short-course radiotherapy (SCRT) (25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adenocarcinoma of the rectum classified as:
- cT1-cT3ab, < 5 cm largest diameter and < ½ circumference (MRI staging), N0-N1 (<= 3 nodes < 8mm diameter), M0
- Performance status (ECOG) 0-1
- Operable patient
- Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm
Key exclusion criteria (16 listed)
- Inoperable patient
- T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference
- Distance from the lower tumor border to the anal verge >10 cm
- N2-status at diagnosis or N1 with any node>= 8 mm diameter
- Patient presenting with metastasis at diagnosis (M1)
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 |
|---|---|---|
| Radiotherapy45/50 Gy (1.8/2 Gy/fraction/5 weeks) | Radiation | CXB + CRT |
| Short-course radiotherapy25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days | Radiation | CXB + SCRT |
| Contact x-ray brachytherapy90Gy/3 fractions/4 weeks | Radiation | CXB + CRT, CXB + SCRT |
| ChemotherapyCapecitabine (900 mg/m2 bid, on radiation days) | Drug | CXB + CRT |
Primary outcome
Rectum preservation
Time frame: At 24 months after start of treatment
Proportion of patients with successful rectum preservation after standard vs experimental treatment. Organ preservation is considered to have failed if the rectum is removed OR if the patient develops non-salvageable locoregional failure
15 secondary outcomes
Acute treatment-related toxicity
Time frame: From start of treatment until 90 days after ending treatment
Late treatment related toxicity
Time frame: From 90 days after ending treatment until end of study
Clinical complete response (cCR)
Time frame: At 14-16 and 24-26 weeks after start of treatment
Postoperative complications
Time frame: Within the first 30 days after Total Mesorectal Excision (TME) surgery
Stoma
Time frame: At 12 and 24 months after start of treatment
Metastasis-free survival
Time frame: At 24 months after start of treatment
Locoregional failure
Time frame: At 24 months after start of treatment
Overall survival
Time frame: At 24 months after start of treatment
TME-free survival
Time frame: At 24 months after start of treatment
Salvage TME resections
Time frame: From 24 weeks after start of treatment until end of study
Tumor regression grade
Time frame: After 14-16 weeks and 24-26 weeks after start of treatment
Sphincter preservation
Time frame: At 24 months after start of treatment
General Health Related Quality of Life (HR QoL)
Time frame: At baseline and at 3, 6, 12, 24, 36, 48 and 60 months after start of treatment
Colorectal cancer specific Health Related Quality of Life (HR QoL)
Time frame: At baseline and at 3, 6, 12, 24, 36, 48 and 60 months after start of treatment
Bowel function
Time frame: At baseline, 3, 6, 12, 24, 36, 48 and 60 months after start of treatment
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 10 Aug 2026.
- Background: PubMed 36801007Gerard JP, Barbet N, Schiappa R, Magne N, Martel I, Mineur L, Deberne M, Zilli T, Dhadda A, Myint AS; ICONE group. Neoadjuvant chemoradiotherapy with radiation dose escalation with contact x-ray brachytherapy boost or external beam radiotherapy boost for organ preservation in early cT2-cT3 rectal adenocarcinoma (OPERA): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):356-367. doi: 10.1016/S2468-1253(22)00392-2. Epub 2023 Feb 16.
- Derived from this study: PubMed 40204311Nilsson PJ, Folkesson J, Marsk R, Radu C, Stratulat I, Blomqvist L, Martling A, Valdman A. Contact radiotherapy for rectal cancer (CORRECT): study protocol for a multicentre randomised phase II trial. BMJ Open. 2025 Apr 9;15(4):e100356. doi: 10.1136/bmjopen-2025-100356.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data that underlie the reported results.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy, Short-course radiotherapy and Contact x-ray brachytherapy in people with Rectal Cancer, run by Alexander Valdman at 2 sites in Sweden.
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 16 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 10 Aug 2026. 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 Sweden. 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 Alexander Valdman, MD, PhD (+46 70 002 13 17, alexander.valdman@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectum preservation (time frame: At 24 months after start of treatment). 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 NCT06501053, 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 10 Aug 2026.