None listed
Conditions
Interventions
Others : 1. Neoadjuvant chemoradiotherapy group (Long-term Simultaneous) (control group)
- Neoadjuvant chemoradiotherapy (1 to 5 or 6 weeks): Patients will receive radiotherapy with a dose of 45 to 46
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically diagnosed locally advanced rectal cancer (stage II/III) (2) The distal border of the tumor located =10 cm from the anal verge (3) Men and women aged 19-80 years (4) No evidence of distant metastasis (including paraaortic LN, common & external iliac LN) on abdominal pelvic CT or chest CT scan (5) ECOG performance =1 and be capable of activities for daily living (6) American Society of Anesthesiologists (ASA) Physical Status Classification System Class I~II (7) No history of any other systemic treatment (chemotherapy, immunotherapy) or radiotherapy for rectal cancer (8) No history of intrapelvic radiotherapy (9)The following investigation criteria should be satisfied: Bone marrow function: absolute neutrophils =1,500/mm3, platelets =75,000/mm3 Liver function: bilirubin =2.0 X upper limit of normal, liver function enzymes level (AST/ALT) =2.5 X upper limit of normal Renal function: creatinine =1.5 X upper limit of normal or renal filtration rate (Ccr, calculated using Cockcroft formula) =50 ml/min (10) Patients who can comply with the study protocol for the duration of the study (11) Patients who understand the study process and treatment plan and have signed the informed consent
Exclusion criteria
Exclusion criteria: (1) Histological carcinoma other than rectal adenocarcinoma or adenocarcinoma arising from inflammatory bowel disease (2) Suspected distant metastasis (3) NCI CTC grade 1 or higher peripheral neuropathy (4) Uncontrolled or severe cardiovascular disease, myocardial infarction within 6 months, NYHA grade 3 or higher heart failure, or uncontrolled angina (5) Infection or other disease that is not currently controlled (6) History of other malignancies within 5 years (except for cured superficial skin cancer or cervical carcinoma in situ) (7) History of organ transplant requiring immunosuppressive therapy (8) Uncontrolled epilepsy or psychosis (9) Pregnant or lactating women, women of childbearing potential who do not intend to actively use contraception, or men who are planning pregnancy or do not intend to actively use contraception (10) Cases required to continue concomitant treatment expected to interact with oxaliplatin, such as flucytosine, phenytoin, or warfarin (11) Previous hypersensitivity to fluoropyrimidine agents or confirmed DPD deficiency (12) Patients on tegafur, gimeracil, or oteracil potassium combinations or those who have stopped the administration of those drugs within 7 days (13) Patients on sorivudine or brivudine (14) Hypersensitivity to platinum, leucovorin, or capecitabine (15) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (16) Participation in other clinical study within 4 weeks prior to the start of the study (17) Patients treated with bevacizumab, cetuximab, oxaliplatin, or irinotecan prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate: The primary efficacy endpoint of this study is complete response rate at the time of surgery as assessed by the investigator. The primary efficacy analysis will be based on the full analysis set (FAS). The FAS analysis is similar to the modified ITT, where all randomized subjects will be reviewed for protocol violations or any other violations, and the minimum level of reasons for exclusion will be applied: violations of major inclusion/exclusion criteria, no administration of investigational products or treatment, or no available data for evaluation of the primary endpoint post-randomization. Except for these major reasons, the subjects will be included in the FAS for analysis as possible. | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Treatment Failure Rate - The treatment failure rate is an outcome measure including local treatment failure, metastatic recurrence, secondary colorectal cancer, and treatment-related death. b. Quality of Life and Function (Patient-Reported Outcomes) - They will be measured through EORTC QLQ-C30/QLQ-CR29 and low anterior resection questionnaire. c. Relevant cost - Total number of hospital visits/costs, chemotherapy costs, etc. will be comprehensively evaluated.;a. ctDNA - Among the treatment outcomes, changes in ctDNA will be measured to confirm whether it is possible to detect a response at earlier phase and a risk of relapse based on ctDNA. | — |
Countries
Korea, Republic of
Contacts
Public ContactKim min jung
Seoul National University Hospital
Outcome results
None listed