Colorectal Cancer, Chemotherapy Effect, Surgery, Metastasis, Survival
Conditions
Keywords
advanced colorectal cancer, hyperthermic intraperitoneal chemotherapy, mitomycin, lobaplatin, prognosis
Brief summary
This study is a prospective, randomized, comparative clinical trial conducted by Wuhan Union Hospital and aim to compare the therapeutic effects of Mitomycin and Lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with hyperthermic intraperitoneal chemotherapy
Detailed description
Hyperthermic intraperitoneal chemotherapy (HIPEC) is traditionally used to treat peritoneal cancer combined with cytoreductive surgery (CRS). Further, there have been more than 20 years for CRS + HIPEC applying in treatment of patients with colorectal cancer peritoneal metastasis. While, to date, the kinds, doses, combinations of HIPEC drugs are not clearly been evaluate a criterion for local advanced colorectal cancer patients. Thus, This study aim to compare the efficacy of Mitomycin and Lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with HIPEC. We plan to recruit 201 patients and divide into 3 groups, 2 drug groups and 1 control group, radomly. all patients with advanced co cancer receive radical surgery + HIPEC + mFOLFOX6/XELOX chemotherapy regimen. the mainly experimental variable is HIPEC drugs and three groups employ Mitomycin, Lobaplatin and none respectively. the endpoints of study include peritoneal metastasis, overall survival, immune status and perioperative safety assessment.
Interventions
DRUGMitomycin
Mitomycin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Mitomycin 30mg/m2. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
DRUGLobaplatin
Lobaplatin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Lobaplatin 50mg/m2. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
the choice of HIPEC drugs is unknown to patients with advanced colorectal cancer, but known to doctors, investigators and outcomes assessors.
Intervention model description
We divide patients into 3 groups randomly. drug group 1: Radical Surgery + HIPEC (mitomycin) + mFOLFOX6/XELOX regimen; drug group 2: Radical Surgery + HIPEC (lobaplatin) + mFOLFOX6/XELOX regimen; control group: Radical Surgery + HIPEC (no drug) + mFOLFOX6/XELOX regimen
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. No chemoradiotherapy or other anti-tumor therapy before clinical trial performed; 2. Aged 18-75 years; 3. Male or non-pregnant or lactating women; 4. Pathological diagnosis of colorectal adenocarcinoma; 5. Clinical diagnosis of T3 stage or above without distant metastasis and can be given radical surgery (AJCC Version 8, 2018); 6. Normal function of major organs; 7. Routine blood examinations meeting the following criteria: A. HB ≥ 90 g/L; B. ANC ≥ 1.5 x 10 9 /L; C. PLT ≥ 125 × 10 9 /L; 8. Chemistry indexs meeting the following criteria: A. TBIL \< 1.5ULN; B. ALT and AST \< 2.5ULN; ALB \> 30 g/L C. serum Cr ≤ 1.25 ULN or endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula); 9. ECOG score 0-1;
Exclusion criteria
1. A history of other malignant tumors within 5 years; 2. Distant metastasis found during surgery; 3. Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs; 4. Suffering from epilepsy or other mental illness, unable to control behavior; 5. Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease; 6. Pregnant or lactating women. 7. Receiving anti-cancer drug therapy from other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| peritoneal metastasis | 3-year | peritoneal metastasis-free survival (pRFS) |
| overall survival | 3-year | overall survival (OS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with immunosuppression events as assessed by blood immunological indicators | up to 4 weeks | Before and After Hyperthermic Intraperitoneal Chemotherapy, collect 5mL blood samples of patients for detecting immunological indicators such as CD3, CD4 and CD8 lymphocyte population; Interferon-γ; tumor necrosis factor (TNF)-α; interleukin-2, 4, 8, 10, etc |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 4 weeks | postoperative adverse events (referring to CTCAE 5.0 \[including blood routine, liver and kidney function, patient reaction to HIPEC, adverse events\]) was analyzed |
| The positive rate of cancer cells of participants by exfoliative cytology examination | 1 week | According to the positive rate of cancer cells measured in exfoliative cytology before and after HIPEC, the difference between the groups is analyzed. |
Contacts
Primary ContactKaixiong Tao, Professor
Backup ContactCuanqing Wu, Doctor
Outcome results
None listed