Contact Radiotherapy for Rectal Cancer
NCT Number: NCT06501053
Acronym: CORRECT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rectal Cancer
Interventions: RADIATION: Radiotherapy|RADIATION: Short-course radiotherapy|RADIATION: Contact x-ray brachytherapy|DRUG: Chemotherapy
Sponsor: Alexander Valdman
Collaborators: Uppsala University Hospital|Karolinska Institutet
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2032-11
Locations: Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer, Stockholm, Solna, 171 76, Sweden|Uppsala University Hospital, Colorectal Surgery, Uppsala, 751 85, Sweden

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).

Primary Outcome Measures: 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, At 24 months after start of treatment
Secondary Outcome Measures: Acute treatment-related toxicity, Incidence of grade 3-5 toxicity as assessed by CTCAE v5.0, 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, 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, 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, Within the first 30 days after Total Mesorectal Excision (TME) surgery|Stoma, Proportion of patients with a stoma, At 12 and 24 months after start of treatment|Metastasis-free survival, Survival without sign of metastasis after standard vs experimental treatment, At 24 months after start of treatment|Locoregional failure, Proportion of patients with locoregional failure after standard vs experimental treatment, At 24 months after start of treatment|Overall survival, Overall survival after standard vs experimental treatment, At 24 months after start of treatment|TME-free survival, Survival without Total Mesorectal Excision after standard vs experimental treatment, At 24 months after start of treatment|Salvage TME resections, Rate of R0 Total Mesorectal Excisions after standard vs experimental treatment, 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, After 14-16 weeks and 24-26 weeks after start of treatment|Sphincter preservation, Rate of sphincter preservation after standard vs experimental treatment, 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, 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, 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., At baseline, 3, 6, 12, 24, 36, 48 and 60 months after start of treatment