Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for Low-risk Rectal Cancer
NCT ID: NCT04405206
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
54 participants
OBSERVATIONAL
2020-05-25
2023-12-30
Brief Summary
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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.
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Detailed Description
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This study is designed to investigate the efficacy of neoadjuvant intensity modulated nCRT with concurrent capecitabine plus consolidation CapeOX for T2/DWI/Enhanced MRI defined cT2-T3b mid-low rectal cancer without threatening mesorectal fascia or extramural vascular invasion (EMVI) or mrN2 disease.
According to the response to treatment evaluated by multi-modal assessment including digital exam, T2/DWI/Enhanced MRI, endoscopy and serum CEA test, patients will receive tailored operative management like local excision or total mesorectal excision, or non-operative management. Intention to treatment was also allowed in this study.
Firstly, the investigators will observe the organ preservation rate at 2 years. Endpoints for organ-preservation like non-regrowth DFS, stoma-free survival and other conventional survival outcomes (DFS, OS) would be further collected. The short-term and long-term QoL will be measured in all patients.
. Our baseline data showed the 48% of locally advanced rectal cancers could be downstaged to stage ypT0-2N0 following IMRT with concurrent capecitabine. We hypothesize that at least 24% of rectal cancers could be candidates for LE or NOM after IMRT and the rectum preservation rate will increase to 40% in low-risk rectal cancers by LE or NOM following IMRT plus consolidation CapeOX at 2 years. As a superiority design, this study need to recruit 64 patients to test this hypothesis, with 85% power (exact binomial test for proportions, alpha = 5 %, one-sided), If the number of responses is 22 or more, the hypothesis that P \<= 0.240 is rejected. We anticipate about 10 % loss to follow-up, so we will recruit an additional 8 patients and the study will recruit 72 patients in all.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
Oxaliplatin
OXA 130mg/m2
Capecitabine
Cape 1000mg/m2
intensity modulated radiotherapy
IMRT 50.4Gy/22f
DRE-Endoscopy-MRI-CEA
examination process in follow up
Nonoperative Management
Watch and Wait
Quality of Life Questionnaires
QLQ C30 and QLQ CR29
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).
Oxaliplatin
OXA 130mg/m2
Capecitabine
Cape 1000mg/m2
intensity modulated radiotherapy
IMRT 50.4Gy/22f
DRE-Endoscopy-MRI-CEA
examination process in follow up
Nonoperative Management
Watch and Wait
Local excision
For ymriT1N0 and near-cCR patients，LE is optional.
Quality of Life Questionnaires
QLQ C30 and QLQ CR29
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
Oxaliplatin
OXA 130mg/m2
Capecitabine
Cape 1000mg/m2
intensity modulated radiotherapy
IMRT 50.4Gy/22f
DRE-Endoscopy-MRI-CEA
examination process in follow up
Total Mesorectal Excision
Standard TME surgery openly or laporoscopically
Quality of Life Questionnaires
QLQ C30 and QLQ CR29
Interventions
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Oxaliplatin
OXA 130mg/m2
Capecitabine
Cape 1000mg/m2
intensity modulated radiotherapy
IMRT 50.4Gy/22f
DRE-Endoscopy-MRI-CEA
examination process in follow up
Nonoperative Management
Watch and Wait
Local excision
For ymriT1N0 and near-cCR patients，LE is optional.
Total Mesorectal Excision
Standard TME surgery openly or laporoscopically
Quality of Life Questionnaires
QLQ C30 and QLQ CR29
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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;
18 Years
85 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Aiwen Wu
Professor
Locations
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Beijing Cancer Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BJCC-R01
Identifier Type: -
Identifier Source: org_study_id
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