Rectal cancer
Conditions
Interventions
Interventional group:Intense total neoadjuvant therapy
Sponsors
The First Affiliated Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Biopsy proven rectal adenocarcinoma with no previous anti-tumor treatment; Age = 18; Pelvic MRI: T3-4, N any, or Tx N+; Tumor located = 5 cm from anal verge, difficult to preserve sphincter after standard chemoradiotherapy considered by surgeon and radiologist, the patient preferred organ preservation; MSS, KRAS and/or NRAS and/or BRAF V600E mutation; ECOG performance score: 0-1; Fit for chemoradiotherapy and chemotherapy, adequate potential for follow-up, signed informed consent; Prepared for carefully clinical examination, including rectal endoscopy, biopsy, sequencing, chest/abdomen/pelvic CT, high-resolution MRI (EMVI, MRF, lateral lymphnodes status); Clinically acceptable hematological, hepatological, renal function.
Exclusion criteria
Exclusion criteria: Distant metastasis, recurrent rectal cancer; Active Crohn’s disease or ulcerative colitis, familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer; Concomitant malignant tumors; Previous pelvic radiotherapy; Contradictions to MRI; Pregnancy or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Free Survival;Quality of Life;Organ Preservation; | — |
Countries
China
Contacts
Public ContactJianjun Li
The First Affiliated Hospital of Army Medical University, PLA
Outcome results
None listed