Neoadjuvant Chemotherapy, Rectal Cancer
Conditions
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.
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.
Interventions
oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals
Sponsors
Chengdu Fifth People's Hospital
The Third People's Hospital of Chengdu
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.
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological Tumor Regression Grade evaluation | 12 weeks | pTRG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed