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

Rectal Cancer Clinical Trial

— COPEC  

Official title:

Comparison of the Pathological Effect Between 2 and 4 Cycles Neoadjuvant CAPOX for Low/Intermediate Risk II/III Rectal Cancer：a Prospective, Non-inferior, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04922853
• Other study ID #: RC-CT-2021
• Status: Recruiting
• Phase: Phase 3
• Start date: August 26, 2021
• Est. completion date: December 1, 2026

Study information

• Verified date: March 2022
• Source: West China Hospital
• Contact: Ziqiang Wang, MD
• Phone: 18980602028
• Email: wangziqiang[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 554
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age: 18-75 years old; No gender limitation;

2. 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

3. tumor located <=12cm from anal verge by colonoscopy or anal examination

4. no distant metastasis confirmed by CT examination;

5. rectal adenocarcinoma confirmed by pathology,

6. ECOG score: 0-1;

7. Patients with primary rectal cancer who did not receive surgery (except palliative stomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy before enrollment;

8. Main organs function normally, that is, meet the following characteristics: ? 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. ? 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.

9. No history of allergy to platinum drugs when no 5-FU drugs are allergic;

10. 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;

11. Subjects volunteered to participate in this study, signed the informed consent, and showed good compliance and followed up.

Exclusion Criteria:

1. patients suspect to Lynch syndrome;

2. Patients showed distant metastasis during treatment;

3. Previously or coexisting malignancies (including concurrent colon cancer), except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;

4. pregnant or breastfeeding women;

5. Patients with severe cardiovascular diseases and diabetes that is not easily controlled;

6. People with mental disorders;

7. Severe infection;

8. sever renal disfunction;

9. History of gastrointestinal fistula, perforation, bleeding, or severe ulcer;

10. Allergic to 5-FU or platinum;

11. 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.

Related Conditions & MeSH terms

• Neoadjuvant Chemotherapy
• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	the Third People'S Hospital of Chengdu	Chengdu	Sichuan
China	West China Hospital	Chengdu	Sichuan
China	The Third Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Genecast Biotechnology Co., Ltd	Wuxi	Jiangsu

Sponsors (15)

Lead Sponsor

Collaborator

West China Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological Tumor Regression Grade evaluation	pTRG	12 weeks
Secondary	rate of chemotherapeutic complication		12 weeks
Secondary	3-year overall survival	the cumulative overall survival rate of the patients(events defined as all caused death)	3 year after recruiting
Secondary	disease free survival	the cumulative disease free survival rate of the patients(events defined as tumor recurrence at any sites)	3 year after recruiting
Secondary	cumulative distant recurrence rate	cumulative recurrence rate of Rectal cancer after the radical surgery outside the pelvic cavity	3 year after recruiting
Secondary	cumulative local recurrence rate	cumulative recurrence rate of Rectal cancer after the radical surgery within the pelvic cavity or in the wounds	3 year after recruiting