An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer
NCT ID: NCT04443543
Last Updated: 2020-06-30
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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NOT_YET_RECRUITING
PHASE2
222 participants
INTERVENTIONAL
2020-06-22
2026-12-31
Brief Summary
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Detailed Description
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Evaluate the CCR rate of low rectal cancer using adaptive and optimized chemotherapy and radiotherapy strategies (all population and dMMR/MSI-H subgroup)
2. Secondary objectives:
2.1 Evaluate the 2-year anal preservation rate, recurrence rate, quality of life, DFS and OS 2.2 Explore the subgroup of patients suitable for observation.
3. Outline:
Patients after long-course chemoradiation are grouped based on their MSI-H/dMMR status. For patients with MSI-H/dMMR, consolidation immunotherapy of Tislelizumab (BGB-A317) will be assigned. For patients with MSS/pMMR, consolidation chemotherapy will be given according to their tumor response. After completion of consolidation therapy, those who reach clinical complete response will receive organ preservation (watch and wait) strategy in place of radical surgery. During treatment, once local regrowth occurs or poor tumor response, total mesorectal excision (TME) surgery will be performed.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Arm 1 includes patients with MSS/pMMR. In this arm, patients receive consolidation chemotherapy after neoadjuvant chemoradiation (nCRT). The chemotherapy regimens either XELIRI or FOLFIRINOX, and the cycles of chemotherapy depend on patient tumor responses. For patients who reach cCR will enter the "W\&W" cohort and omit radical surgery, while those without cCR will receive radical surgery.
Capecitabine (Xeloda) Pharmacogenetic Test Reagents
CRT: 625mg/m2 bid Monday-Friday per week XELIRI: 1000mg/m2 bid d1-14
irinotecan
CRT:80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) XELIRI: 200mg/m2 bid d1 FOLFIRINOX: 150mg/m2 d1
IMRT
Pelvic Radiation: 50Gy/25Fx
Oxaliplatin
FOLFIRINOX: 85mg/m2 d1
5Fluorouracil
FOLFIRINOX: 400mg/m2 iv d1bolus, 2400mg/m2 ivgtt 46h
Arm 2
Arm 2 includes patients with MSI-H/dMMR status. In this arm, patients receive consolidation immunotherapy of 3 cycles of tislelizumab after nCRT. For patients who reach cCR will enter the "W\&W" cohort and omit radical surgery, while those without cCR will receive radical surgery.
Capecitabine (Xeloda) Pharmacogenetic Test Reagents
CRT: 625mg/m2 bid Monday-Friday per week XELIRI: 1000mg/m2 bid d1-14
irinotecan
CRT:80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) XELIRI: 200mg/m2 bid d1 FOLFIRINOX: 150mg/m2 d1
IMRT
Pelvic Radiation: 50Gy/25Fx
Tislelizumab
200mg iv
Interventions
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Capecitabine (Xeloda) Pharmacogenetic Test Reagents
CRT: 625mg/m2 bid Monday-Friday per week XELIRI: 1000mg/m2 bid d1-14
irinotecan
CRT:80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) XELIRI: 200mg/m2 bid d1 FOLFIRINOX: 150mg/m2 d1
IMRT
Pelvic Radiation: 50Gy/25Fx
Oxaliplatin
FOLFIRINOX: 85mg/m2 d1
5Fluorouracil
FOLFIRINOX: 400mg/m2 iv d1bolus, 2400mg/m2 ivgtt 46h
Tislelizumab
200mg iv
Eligibility Criteria
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Inclusion Criteria
* clinical stage T2-4 and/or N+, inappropriate for local excision
* the distance from anal verge less than 5 cm, or considered inappropriate for anal preservation by surgeons.
* Strong desire to preserve the anus, able to receive close surveillance for at least 2 years after chemoradiotherapy.
* without distance metastases
* aged between 18 to 75 years old.
* performance status score: 0\~1
* UGT1A1\*28 6/6 or 6/7
* sign the inform consent
Exclusion Criteria
* serious medical illness
* difficult to achieve complete response assessed by current evidence: the maximal diameter of tumor \>10cm; the maximal diameter of lateral lymph node \>2cm; baseline CEA\>=100; biopsy pathology confirmed signet ring cell carcinoma components; digital rectal examination found that the tumor is peri-narrowed.
* baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
* DPD deficiency
* UGT1A1\*28 7/7
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhu Ji
principle investigator
Locations
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Fudan University Shanghai Cancer Cencer
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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CARTOnG-2001
Identifier Type: -
Identifier Source: org_study_id
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