COPEC: Comparison of the Pathological Effect Between 2 and 4 Cycles Neoadjuvant CAPOX for Low/Intermediate Risk II/III Rectal Cancer
Study Details
Study Description
Brief Summary
To compare the pathological effect between 2 cycles and 4 cycles of Capox regimen as neoadjuvant chemotherapy for low/ intermediate risk stage II/III rectal cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Neoadjuvant Chemotherapy alone has showed much benefit for low/ intermediate risk stage II/III rectal cancer which would be verified by the PROSPECT trial. However, the effect of the Neoadjuvant chemotherapy was heterogeneous in different patients. It's important to verify those chemo-resistant cases as early as possible. So that, this trial will compare the pathological effect between 2 cycles and 4 cycles of Capox regimen as neoadjuvant chemotherapy for low/ intermediate risk stage II/III rectal cancer to explore whether those chemotherapeutic non-responders after 2 cycles Capox was non-inferior to those after 4 cycles chemotherapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 2 cycles group patients which recruited have 2 cycles Capox regimen (oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals), then those patients with no sever chemotheraputic AE, have TME operation after reevaluation and randomization. |
Drug: Capox chemotherapy
oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals
|
| Other: 4 cycles group patients which recruited have 2 cycles Capox regimen (oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals), then those patients with no sever chemotheraputic AE, have two more cycles chemotherapy and TME operation after reevaluation and randomization. |
Drug: Capox chemotherapy
oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals
|
Outcome Measures
Primary Outcome Measures
- pathological Tumor Regression Grade evaluation [12 weeks]
pTRG
Secondary Outcome Measures
- rate of chemotherapeutic complication [12 weeks]
- 3-year overall survival [3 year after recruiting]
the cumulative overall survival rate of the patients(events defined as all caused death)
- disease free survival [3 year after recruiting]
the cumulative disease free survival rate of the patients(events defined as tumor recurrence at any sites)
- cumulative distant recurrence rate [3 year after recruiting]
cumulative recurrence rate of Rectal cancer after the radical surgery outside the pelvic cavity
- cumulative local recurrence rate [3 year after recruiting]
cumulative recurrence rate of Rectal cancer after the radical surgery within the pelvic cavity or in the wounds
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 18-75 years old; No gender limitation;
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Patients diagnosed with low/intermediate risk stage II/III rectal cancer under MRI and transanal ultrasound,defined as: low:T3a-bN0-1M0, EMVI (±), MRF (-) (≥2mm); Middle-high rectal cancer: T3a-cN0-1M0, EMVI (±), MRF (-) (≥2mm); No more than 3 lymph nodes with short diameter over 8mm or highly suspected metastases; Patients with very low rectal cancer who met the above criteria and could achieve negative circumferential resection margin under ELAPE surgery could be included in the group
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tumor located <=12cm from anal verge by colonoscopy or anal examination
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no distant metastasis confirmed by CT examination;
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rectal adenocarcinoma confirmed by pathology,
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ECOG score: 0-1;
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Patients with primary rectal cancer who did not receive surgery (except palliative stomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy before enrollment;
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Main organs function normally, that is, meet the following characteristics: ① Blood routine examination criteria should meet: Hb ≥9g/dL, WBC ≥ 3.5/4.0×109/L, neutrophils ≥ 1.5×109/L, PLT≥ 100×109/L. ② Biochemical tests should meet the following criteria: CREA and BIL ≤ 1.0 times upper limit of normal (ULN), ALT and AST≤ 2.5 times upper limit of normal (ULN), alkaline phosphatase (ALP) ≤2.5×UNL, total bilirubin (TBIL) ≤1.5×UNL.
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No history of allergy to platinum drugs when no 5-FU drugs are allergic;
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Women of childbearing age must have had a pregnancy test (serum or urine) 7 days prior to enrolment, be negative, and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last dosing. For men, surgical sterilization or consent to use an appropriate method of contraception during the trial or for 8 weeks after the last dosing;
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Subjects volunteered to participate in this study, signed the informed consent, and showed good compliance and followed up.
Exclusion Criteria:
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patients suspect to Lynch syndrome;
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Patients showed distant metastasis during treatment;
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Previously or coexisting malignancies (including concurrent colon cancer), except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
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pregnant or breastfeeding women;
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Patients with severe cardiovascular diseases and diabetes that is not easily controlled;
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People with mental disorders;
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Severe infection;
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sever renal disfunction;
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History of gastrointestinal fistula, perforation, bleeding, or severe ulcer;
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Allergic to 5-FU or platinum;
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The presence of serious gastrointestinal diseases that affect the absorption of oral chemotherapeutic drugs; (12) Participants in additional clinical trials within 4 weeks prior to the start of treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Genecast Biotechnology Co., Ltd | Wuxi | Jiangsu | China | 214104 |
| 2 | the Third People'S Hospital of Chengdu | Chengdu | Sichuan | China | 610000 |
| 3 | West China Hospital | Chengdu | Sichuan | China | 610000 |
| 4 | The Third Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
Sponsors and Collaborators
- West China Hospital
- The Third People's Hospital of Chengdu
- Chengdu Fifth People's Hospital
- Peking Union Medical College
- Peking University Cancer Hospital & Institute
- Sun Yat-sen University
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Yunnan Cancer Hospital
- The First Affiliated Hospital of Zhengzhou University
- The Affiliated Hospital Of Guizhou Medical University
- Sichuan Provincial People's Hospital
- Nanchong Central Hospital
- Dazhou Central Hospital
- Leshan People's Hospital
- GeneCast Biotechnology Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC-CT-2021