Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04370925 |
Recruitment Status :
Recruiting
First Posted : May 1, 2020
Last Update Posted : June 16, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Procedure: Radical colectomy Procedure: HIPEC Drug: Systemic chemotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 688 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy After Colectomy in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis |
Actual Study Start Date : | June 4, 2020 |
Estimated Primary Completion Date : | April 30, 2024 |
Estimated Study Completion Date : | April 30, 2026 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Matched control
Patients undergo radical resection of primary colorectal cancer and receive standard adjuvant systemic chemotherapy
|
Procedure: Radical colectomy
Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic) Drug: Systemic chemotherapy Systemic chemotherapy regimens: CapeOx and mFOLFOX6 are preferred for stage Ⅲ patients. CapeOx:oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles. mFOLFOX6:oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles. For stageⅡpatiens, regimens recommend by NCCN guide line(2019 v1) are acceptable. |
Experimental: HIPEC
Patients undergo radical resection of colorectal cancer and HIPEC simultaneously or within 2 days after primary tumor resection. Followed by standard adjuvant systemic chemotherapy
|
Procedure: Radical colectomy
Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic) Procedure: HIPEC HIPEC(simultaneously or within 2days after resection) with mitomycin c (30 mg/m2) at 43°C for 90 minutes. Drug: Systemic chemotherapy Systemic chemotherapy regimens: CapeOx and mFOLFOX6 are preferred for stage Ⅲ patients. CapeOx:oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles. mFOLFOX6:oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles. For stageⅡpatiens, regimens recommend by NCCN guide line(2019 v1) are acceptable. |
- Peritoneal recurrence free survival [ Time Frame: 3-year ]Peritoneal recurrence free survival is calculated from the date of randomization to the date of record peritoneal recurrence(with or without other metastasis), ovarian metastasis, malignant ascites, or death from any cause, whichever occurred first.
- Disease free survival [ Time Frame: 3-year ]Disease free survival is calculated from randomization to to the date of a first relapse, the diagnosis of a secondary colorectal cancer after the initial diagnosis, or death from any cause, whichever occurred first.
- Overall survival [ Time Frame: 5-year ]Overall survival is calculated from randomization to death from any cause.
- Liver metastatic rate [ Time Frame: 3-year ]Liver metastatic rate is calculated from randomization to to the date of liver metastasis with or without other organ metastasis.
- Number of participants with adverse events [ Time Frame: Up to 1 month after the last chemotherapy cycle ]Incidence of acute and late toxicity
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 18 and 70 years
- Nonpregnant or breast-feeding women
- ECOG status 0-1
- Colorectal adenocarcinoma or mucinous adenocarcinoma;
- Intraoperative confirmed cT4N0-2M0 Colorectal cancer (visual determination - according to AJCC 8th edition) without previous anti-cancer treatment and R0 resection could be achieved
- Laboratory tests within 2 weeks before Randomization:Neutrophil ≥ 2.0 /mm3, , platelets ≥ 100,000/mm3, hemoglobin≥90g/l, Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ×ULN), total bilirubin(TBIL)≤ 1.5 × ULN, serum creatinine ≤ 1.5 ×ULN
- Written informed consent
Exclusion Criteria:
- Rectal cancer below peritoneal reflection
- Concurrent with or have other cancer within the past 5 years ( except for skin basal cell carcinoma, or cervical carcinoma in situ, who have received radical treatment)
- Severe abdominal infection or extensive fibrosis of peritoneal cavity that lead to impossible separation
- Surgical procedures conversion(from robotic or laparoscopic surgery to laparotomy) or emergency surgery due to perforation or obstruction
- Existence of distance metastasis during surgery (M1) or can not achieve R0 resection
- Contraindiction of mitomycin c(chickenpox or shingles)
- Poorly controlled respiratory or cardiac disease, severe hepatic or renal dysfunction,drug abuse or uncontrolled mental disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370925
Contact: Shuzhong Cui, MD | 086-13802513800 | cuishuzhong@gzhmu.edu | |
Contact: Tianpei Guan, MD | 086-13660895051 | dr_guan@126.com |
Responsible Party: | Affiliated Cancer Hospital & Institute of Guangzhou Medical University |
ClinicalTrials.gov Identifier: | NCT04370925 |
Other Study ID Numbers: |
HIPEC-06 |
First Posted: | May 1, 2020 Key Record Dates |
Last Update Posted: | June 16, 2020 |
Last Verified: | April 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Colorectal cancer Colectomy Hyperthermic intraperitoneal chemotherapy Peritoneal carcinomatosis |
Colorectal Neoplasms Carcinoma Peritoneal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Abdominal Neoplasms Peritoneal Diseases |