Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for Low-risk Rectal Cancer
BJCC-R01
1 other identifier
observational
54
1 country
1
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 treatment. Meanwhile we will look into the role of ctDNA in the prediction of regrowth and metastasis in the wait and wait process. Methods: Low-risk rectal cancer with following MRI features are recruited: mid-low tumor, mrT2-3b, MRF(-), EMVI(-), differentiation grade 1-3. Patients will receive IMRT 50.6Gy/22f with concurrent capecitabine and 4 cycles of consolidation CAPEOX. Patients with cCR/near-cCR were recommended for 'watch \& wait' approach or local excision (LE). The OPR and sphincter preservation rate (SPR) at 2 years will be analyzed. As the extension of PKUCH-R01, BJCC-R01 trial will upgrade to a multi-center research enrolled 3 other colorectal center in Beijing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2020
CompletedStudy Start
First participant enrolled
May 25, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedOctober 14, 2020
October 1, 2020
3.6 years
May 23, 2020
October 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OPR(organ preservation rate)
Proportion of patients who achieved cCR or near cCR after neoadjuvant treatment and received watch and wait approach or local excision
3 year
Secondary Outcomes (2)
NR-DFS(Non-regrowth disease free survival)
3 year
SFS(stoma-free survival)
3 year
Study Arms (3)
Group A:Clinical complete response (cCR)
Group A:Clinical complete response (cCR) Patients who achieve cCR when restaged by DRE-Endoscopy-MRI-CEA at 16 weeks following intensity modulated radiotherapy(IMRT) plus consolidation CapeOX(Capecitabine+Oxaliplatin) will receive Nonoperative Management(NOM).
Group B:Near-cCR
Patients who achieve near-cCR when restaged by DRE-Endoscopy-MRI-CEA at 16 weeks following intensity modulated radiotherapy(IMRT) plus consolidation CapeOX(Capecitabine+Oxaliplatin) will receive Local Excision(LE) or Nonoperative Management(NOM).
Group C:Residual tumor
Patients with residual tumor when restaged by DRE-Endoscopy-MRI-CEA at 16 weeks following intensity modulated radiotherapy(IMRT) plus consolidation
Interventions
OXA 130mg/m2
Cape 1000mg/m2
IMRT 50.4Gy/22f
examination process in follow up
Watch and Wait
For ymriT1N0 and near-cCR patients，LE is optional.
Standard TME surgery openly or laporoscopically
QLQ C30 and QLQ CR29
Eligibility Criteria
Rectal cancer patient who receives primary care in Beijing Cancer Hospital will be selected as the candidate for this study.
You may qualify if:
- \. the age is more than 18 years old and less than 85 years old;
- \. ECOG score of physical condition is 0-1;
- \. adenocarcinoma of rectum confirmed by pathology; differentiated into Grade 1-3, i.e. high, medium and low differentiated adenocarcinoma
- \. the distance from the lower edge of the tumor to the anal edge ≤ 12cm (endoscopy) or to the anorectal ring (ARJ) ≤ 8cm;
- \. 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
- \. the maximum diameter of tumor ≤ 4cm or the circumferentially invasive area is less than 1 / 3 of intestinal circumference
- \. no evidence of distant metastasis;
- \. no history of pelvic radiotherapy;
- \. no history of surgery or chemotherapy for rectal cancer;
- \. systemic infection without antibiotic treatment;
- \. blood routine test: neutrophil absolute value \> 1.5 × 10 9 / L, HGB \> 10.0 g / dl, PLT \> 100 × 10 9 / L;
- \. blood biochemistry: total bilirubin ≤ 1.5 x ULN, AST ≤ 3 x ULN, ALT ≤ 4 x ULN;
- \. the patient read and signed the informed consent of the study and agreed to participate in the study;
You may not qualify if:
- \. recurrent rectal cancer;
- \. initial local non resectable rectal cancer (no possibility of R0 whole block resection);
- \. the creatinine level is 1.5 times higher than the upper limit of normal value;
- \. have a history of pelvic radiotherapy;
- \. the patients could not tolerate the enhanced MRI;
- \. 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);
- \. in the past 6 months, the patients had arterial embolism diseases, such as angina, MI, TIA, CVA, etc;
- \. have received other types of anti-tumor or experimental treatment;
- \. the patients are pregnant or lactating women;
- \. patients with other diseases or mental disorders may affect their participation in this study;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, 100142, China
Biospecimen
FFPE and peripheral blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 23, 2020
First Posted
May 28, 2020
Study Start
May 25, 2020
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
October 14, 2020
Record last verified: 2020-10