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Multicentric randomised trial. The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to decrease the rate of peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer. The safety of this treatment will also be studied.
Hyperthermic intraperitoneal chemotherapy(HIPEC) is a recently validated option for the treatment of peritoneal carcinomatosis from colorectal or ovarian origin. This therapeutic program demonstrated a significant improvement of overall survival of the disease. It is not yet known whether surgery followed by HIPEC is effective on decreasing the rate of peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer.Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC), defined by Colorectal Cancer With a Resected Minimal Synchronous PC or Ovarian Metastases, or identified T4 by intraoperative pathological diagnosis, or Tumour Rupture in the Abdominal Cavity. If patients with a high risk of developing PC identified by preoperative examination, they will be informed and will sign the consent. After complete resection of their tumor, they will be randomised to surveillance alone (control group) or HIPEC (experimental group). All patients will receive the current standard postoperative adjuvant treatment : 6 months of systemic chemotherapy (currently including FOLFOX4, mFOLFOX6, CapeOx or Capecitabine regimen which could be modified if the standard is modified). Then a work-up is done to find recurrence. If the recurrence occurs, the patient will be treated with the best known treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | surgery alone | |
| Hipec | Experimental | Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC | Procedure | HIPEC with MMC: Mitomycin C (MMC) (30 mg/m2 of body surface area). Closed technique, as preferred. Duration: 60 minutes. Mean Intra-abdominal Temperature: 43°C. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | DFS | Three years from the date of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 3 year overall survival | 3-OS | 3 years |
| Peritoneal disease-free survival | PDFS | 3 years |
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Inclusion Criteria:
Patients presenting with the following history:
Histologically-proven colorectal adenocarcinoma
Presenting at the time of resection of the primary with one of the following 5 criteria (criteria indicating a high risk of developing PC) :
Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :
Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy
Patients with the following general characteristics:
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| Name | Affiliation | Role |
|---|---|---|
| Kefeng Ding, Prof. | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Fujian Medical University | Fuzhou | Fujian | 350001 | China | ||
| Liaoning Cancer Hospital |
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| 5 year overall survival | 5-OS | 5 years |
| morbidity | Toxicity induced by HIPEC using the NCI CTC criteria; one month and six months morbidity. Subgroup analysis: pT4; pts. ≤ 40yrs. | Baseline before any treatment,3 months post operation, 1 year post operation |
| QOL | Duration of operation; return of bowel function; length of hospital stay; return to normal activity; six months and one year QOL, using the SF-36 v1.0; percentage of patients in both arms completing the scheduled postoperative chemotherapy; Subgroup analysis: pT4; pts. ≤ 40yrs. | Baseline before any treatment,3 months post operation, 1 year post operation |
| Shenyang |
| Liaoning |
| 110042 |
| China |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| The First Affiliated Hospital of College of Medicine Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Second Affiliated Hospitalof Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Jinhua People's Hospital | Jinhua | Zhejiang | 321000 | China |
| People's Hospital of Shaoxing | Shaoxing | Zhejiang | 312000 | China |
| Yuyao People's Hospital | Yuyao | Zhejiang | 315400 | China |
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
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