Comparing 2 vs 4 cycles of chemotherapy for rectal cancer

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

This study is testing whether getting 2 cycles of chemotherapy instead of 4 can still be effective for people with low to intermediate risk stage II/III rectal cancer.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 554 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: West China Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Wuxi, Jiangsu and 3 other locations)
• Trial ID: NCT04922853 on ClinicalTrials.gov

What this trial studies

This trial aims to compare the pathological effects of administering 2 cycles versus 4 cycles of the Capox chemotherapy regimen as neoadjuvant treatment for patients with low to intermediate risk stage II/III rectal cancer. The study is designed to identify potential chemoresistant cases early by evaluating the response to the chemotherapy after the initial 2 cycles. Patients will be monitored for their pathological outcomes to determine if those who do not respond to the shorter regimen are non-inferior to those receiving the longer treatment. This approach seeks to optimize treatment strategies for rectal cancer patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with low/intermediate risk stage II/III rectal cancer who have not undergone prior treatments.

Not a fit: Patients with distant metastasis or those who have previously received chemotherapy or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective chemotherapy regimens for patients with rectal cancer.

How similar studies have performed: Previous studies have shown the benefits of neoadjuvant chemotherapy in rectal cancer, but this specific comparison of cycle duration is novel.

Eligibility criteria

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: 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.
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.

Where this trial is running

Wuxi, Jiangsu and 3 other locations

• Genecast Biotechnology Co., Ltd — Wuxi, Jiangsu, China (NOT_YET_RECRUITING)
• the Third People'S Hospital of Chengdu — Chengdu, Sichuan, China (RECRUITING)
• West China Hospital — Chengdu, Sichuan, China (RECRUITING)
• The Third Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (RECRUITING)

Study contacts

• Study coordinator: Ziqiang Wang, MD

Conditions: Rectal Cancer, Neoadjuvant Chemotherapy