Status:
UNKNOWN
Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for Low-risk Rectal Cancer
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Rectum Cancer
Eligibility:
All Genders
18-85 years
Brief Summary
Aim: To investigate the safety and efficacy of organ preservation (OP) with watch-and-wait strategy (W\&W) or local excision (LE) in MRI stratified low-risk rectal cancer treated by total neoadjuvant ...
Detailed Description
Neoadjuvant chemoradiotherapy (nCRT), total mesorectal excision and adjuvant chemotherapy comprise the standard treatment for locally advanced rectal cancer, following which 15-30% patients achieved p...
Eligibility Criteria
Inclusion
- 1\. the age is more than 18 years old and less than 85 years old;
- 2\. ECOG score of physical condition is 0-1;
- 3\. adenocarcinoma of rectum confirmed by pathology; differentiated into Grade 1-3, i.e. high, medium and low differentiated adenocarcinoma
- 4\. the distance from the lower edge of the tumor to the anal edge ≤ 12cm (endoscopy) or to the anorectal ring (ARJ) ≤ 8cm;
- 5\. the initial MRI was T2 / T3a / T3B, with negative EMVI and negative CRM. There was no lymph node metastasis outside the ilium, general ilium, obturator and abdominal aorta
- 6\. the maximum diameter of tumor ≤ 4cm or the circumferentially invasive area is less than 1 / 3 of intestinal circumference
- 7\. no evidence of distant metastasis;
- 8\. no history of pelvic radiotherapy;
- 9\. no history of surgery or chemotherapy for rectal cancer;
- 10\. systemic infection without antibiotic treatment;
- 11\. blood routine test: neutrophil absolute value \> 1.5 × 10 9 / L, HGB \> 10.0 g / dl, PLT \> 100 × 10 9 / L;
- 12\. blood biochemistry: total bilirubin ≤ 1.5 x ULN, AST ≤ 3 x ULN, ALT ≤ 4 x ULN;
- 13\. the patient read and signed the informed consent of the study and agreed to participate in the study;
Exclusion
- 1\. recurrent rectal cancer;
- 2\. initial local non resectable rectal cancer (no possibility of R0 whole block resection);
- 3\. the creatinine level is 1.5 times higher than the upper limit of normal value;
- 4\. have a history of pelvic radiotherapy;
- 5\. the patients could not tolerate the enhanced MRI;
- 6\. malignant tumors whose survival rate in the past 5 years is significantly lower than that of rectal cancer in our center (excluding well treated basal cell carcinoma, skin squamous carcinoma, small renal carcinoma, breast cancer and thyroid papillary carcinoma);
- 7\. in the past 6 months, the patients had arterial embolism diseases, such as angina, MI, TIA, CVA, etc;
- 8\. have received other types of anti-tumor or experimental treatment;
- 9\. the patients are pregnant or lactating women;
- 10\. patients with other diseases or mental disorders may affect their participation in this study;
Key Trial Info
Start Date :
May 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04405206
Start Date
May 25 2020
End Date
December 30 2023
Last Update
October 14 2020
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, China, 100142