Locally advanced rectal cancer
Conditions
Interventions
The study protocol consists of preoperative treatment with short course radiotherapy (SCRT) and preoperative chemotherapy, and non-operative management (NOM) or surgical treatment based on re-stating.
Sponsors
Yoshino Takayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The subject has been fully informed of the details of the study and his/her written consent has been obtained. (2) Adenocarcinoma confirmed by histological examination. (3) No distant metastasis is identified on imaging examination, and radical resection is clinically feasible. (4) Subject is at least 18 years of age on the date of consent. (5) ECOG Performance Status (PS) of 0 - 1 (PS 0 if the subject is 70 years of age or older on the date of consent). (6) The lower margin of the tumor is within 12 cm of the anal verge (AV). (7) No prior treatment for the tumor. (8) No prior pelvic radiation therapy, including treatment for other types of cancer. (9) Subjects with cT3-4N0M0 or T1-4N1-2M0 based on UICC 8th edition. ( For 5cm= 1500/mm3 b. Platelet count >=10.0 x 104 /mm3 c. Hemoglobin concentration >= 9.0 g/dL d. Total bilirubin = 30 mL/min
Exclusion criteria
Exclusion criteria: (1) Subject has undergone extensive surgery within 4 weeks prior to the start of protocol treatment (excluding colostomy and central venous port). (2) Complication or previous history of severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema, etc.). (3) Colorectal stent implantation. (4) Cardiac pacemaker or other contraindications to MRI. (5) Subject has severe comorbidities (heart failure, renal failure, liver failure, intestinal paralysis, bowel obstruction, uncontrolled diabetes, active inflammatory bowel disease, etc.). (6) Prior or concurrent malignancy < 5 years prior to enrolment in study (7) Pregnant or lactating women, positive pregnancy test or unwillingness to use contraception. (8) HBs antigen positive or HCV antibody positive. However, if the HCV-RNA is negative, the subject is eligible for enrollment. (9) Known human immunodeficiency virus (HIV) infection. (10) Known microsatellite instability - high (MSI-H) or deficient mismatch repair (dMMR). (11) The applicant does not intend to consent to the "Research on Genetic Profiling and Clinical Significance Using Clinical Specimens from Cancer Subjects" (CONDUCTOR Study) (12) The investigator or principal investigator judges that the subject is inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Organ preservation adapted disease free survival (DFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints Clinical complete response (cCR) rate Clinical response (cCR + near CR: nCR) rate Non operative management (NOM) selection ratio Recurrence location and recurrence rate Distant metastasis free survival (DMFS) Local recurrence free survival (LRFS) Overall survival (OS) Total mesorectal excision (TME) -free survival TME-free disease-free survival Protocol treatment completion rate Relative Dose Intensity (RDI) QOL evaluation (LARS score, EORTC QLQ-C30, SF-36) Preoperative treatment-related adverse event rate by CTCAE ver5.0 Subgroups evaluation in TME group Pathological complete response (pCR) rate Radical resection rate Local recurrence free survival (LRFS) Percentage of surgery-related adverse events rate by Clavien-Dindo classification v2.0 Subgroups evaluation in NOM group Local re-growth rate Time to local re-growth Salvage surgery rate in cases of local re-growth Time to salvage surgery Percentage of surgery-related adverse events by Clavien-Dindo classification v2.0 in salvage surgery cases Radical resection rate in salvage surgery cases | — |
Contacts
Public ContactHideaki Bando
National Cancer Center Hospital East
Outcome results
None listed