Comparison of the Pathological Effect Between 2 and 4 Cycles Neoadjuvant CAPOX for Low/Intermediate Risk II/III Rectal Cancer (COPEC)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2026
  • participants needed
    554
  • sponsor
    West China Hospital
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Updated on 18 April 2022
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metastasis
oxaliplatin
capecitabine
adenocarcinoma

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.

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.

Details
Condition Rectal Cancer, Neoadjuvant Chemotherapy
Treatment Capox chemotherapy
Clinical Study IdentifierNCT04922853
SponsorWest China Hospital
Last Modified on18 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age: 18-75 years old; No gender limitation
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
tumor located <=12cm from anal verge by colonoscopy or anal examination
no distant metastasis confirmed by CT examination
rectal adenocarcinoma confirmed by pathology
ECOG score: 0-1
Patients with primary rectal cancer who did not receive surgery (except palliative stomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy before enrollment
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
No history of allergy to platinum drugs when no 5-FU drugs are allergic
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
Subjects volunteered to participate in this study, signed the informed consent, and showed good compliance and followed up

Exclusion Criteria

patients suspect to Lynch syndrome
Patients showed distant metastasis during treatment
Previously or coexisting malignancies (including concurrent colon cancer), except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix
pregnant or breastfeeding women
Patients with severe cardiovascular diseases and diabetes that is not easily controlled
People with mental disorders
Severe infection
sever renal disfunction
History of gastrointestinal fistula, perforation, bleeding, or severe ulcer
Allergic to 5-FU or platinum
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
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