Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2025-03-03
2032-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CXB + CRT
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).
Radiotherapy
45/50 Gy (1.8/2 Gy/fraction/5 weeks)
Contact x-ray brachytherapy
90Gy/3 fractions/4 weeks
Chemotherapy
Capecitabine (900 mg/m2 bid, on radiation days)
CXB + SCRT
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).
Short-course radiotherapy
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 brachytherapy
90Gy/3 fractions/4 weeks
Interventions
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Radiotherapy
45/50 Gy (1.8/2 Gy/fraction/5 weeks)
Short-course radiotherapy
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 brachytherapy
90Gy/3 fractions/4 weeks
Chemotherapy
Capecitabine (900 mg/m2 bid, on radiation days)
Eligibility Criteria
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Inclusion Criteria
* 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
* No comorbidity preventing treatment
* Patient having read the information note and having signed the informed consent
* Follow-up possible
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Uppsala University Hospital
OTHER
Karolinska Institutet
OTHER
Alexander Valdman
OTHER
Responsible Party
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Alexander Valdman
National Principal Investigator
Locations
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Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer
Stockholm, Solna, Sweden
Uppsala University Hospital, Colorectal Surgery
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Nilsson 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.
Other Identifiers
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CORRECT
Identifier Type: -
Identifier Source: org_study_id
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