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

NCT04922853 | Active Not Recruiting Phase 3

• 1 other identifier: RC-CT-2021
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 4

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.

Conditions

Rectal Cancer; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• pathological Tumor Regression Grade evaluation

  pTRG

  12 weeks

Secondary Outcomes (5)

• rate of chemotherapeutic complication

  12 weeks

• 3-year overall survival

  3 year after recruiting

• disease free survival

  3 year after recruiting

• cumulative distant recurrence rate

  3 year after recruiting

• cumulative local recurrence rate

  3 year after recruiting

Study Arms (2)

2 cycles group

EXPERIMENTAL

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

4 cycles group

OTHER

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

Interventions

Capox chemotherapy DRUG

oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals

2 cycles group; 4 cycles group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead
• The Third People's Hospital of Chengdu: collaborator
• Chengdu Fifth People's Hospital: collaborator
• Peking Union Medical College: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Sun Yat-sen University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Yunnan Cancer Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Sichuan Provincial People's Hospital: collaborator
• Nanchong Central Hospital: collaborator
• Dazhou Central Hospital: collaborator
• Leshan People's Hospital: collaborator
• GeneCast Biotechnology Co., Ltd.: collaborator

Study Sites (4)

Genecast Biotechnology Co., Ltd

Wuxi, Jiangsu, 214104, China

Location

the Third People'S Hospital of Chengdu

Chengdu, Sichuan, 610000, China

Location

West China Hospital

Chengdu, Sichuan, 610000, China

Location

The Third Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Related Publications (1)

• Shen Y, Shi W, Huang C, Gong X, Wei M, Meng W, Deng X, Wang Z; COPEC groups. Comparison of the pathological response to 2 or 4 cycles of neoadjuvant CAPOX in II/III rectal cancer patients with low/intermediate risks: study protocol for a prospective, non-inferior, randomized control trial (COPEC trial). Trials. 2023 Jun 13;24(1):397. doi: 10.1186/s13063-023-07405-x.

  PMID: 37312165 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 11, 2021
• Study Start: August 26, 2021
• Primary Completion: October 1, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

CN (4)