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Trial record 11 of 42 for:    Malignant Hyperthermia 5

Trial Evaluating Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis

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ClinicalTrials.gov Identifier: NCT02179489
Recruitment Status : Recruiting
First Posted : July 1, 2014
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ding Ke-Feng, Zhejiang University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 Metastases to Ovary Peritoneal Carcinomatosis Procedure: Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Multicentric Phase III Trial Comparing Simple Surgery to Surgery Plus HIPEC (Hyperthermic Intraperitoneal Chemotherapy) With MMC in Colorectal Patients Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis
Study Start Date : October 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
No Intervention: Control
surgery alone
Experimental: Hipec
Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC
Procedure: Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC
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.




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: Three years from the date of randomization ]

Secondary Outcome Measures :
  1. 3 year overall survival [ Time Frame: 3 years ]
  2. Peritoneal disease-free survival [ Time Frame: 3 years ]
  3. 5 year overall survival [ Time Frame: 5 years ]
  4. Toxicity [ Time Frame: Baseline before any treatment,3 months post operation, 1 year post operation ]

    Toxicity induced by HIPEC using the NCI CTC criteria; one month and six months morbidity.

    Subgroup analysis: pT4; pts. ≤ 40yrs.


  5. Quality of life [ Time Frame: Baseline before any treatment,3 months post operation, 1 year post operation ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting with the following history:

    1. Histologically-proven colorectal adenocarcinoma
    2. Presenting at the time of resection of the primary with one of the following 5 criteria (criteria indicating a high risk of developing PC) :

      • Minimal PC, resected at the same time as the primary
      • Ovarian metastases
      • Rupture of the primary tumour inside the peritoneal cavity,
      • Intraoperative rupture of the primary tumour during surgery
      • Histologically-proven T4 colorectal adenocarcinoma
  • Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :

    1. Chemotherapy with FOLFOX4, mFOLFOX6, CapeOx or Capecitabine(the current standard treatment; it can be modified in the future in the two groups, if the standard is modified)
    2. Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons)
  • 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:

    1. Age between 18 and 75 years
    2. Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks
    3. Adequate renal, and bone marrow function: a. Leukocytes >/= 3,000/microL; b. Absolute neutrophil count >/= 1,500/microL; c. Platelets >/= 100,000/Ul; d. Serum creatinine </= 1.5 mg/dL
    4. Hepatic function: a. AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal) ULN
    5. Operable patients
    6. Completion of neoadjuvant systemic chemotherapy
  • Patients will be informed and a signed consent before initiating any procedure specific to the trial

Exclusion Criteria:

  1. Cancers of non colorectal origin
  2. Patients presenting with a detectable recurrent tumour
  3. History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
  4. Known HIV, Hepatitis B or Hepatitis C positive
  5. Pregnant women or likely to be pregnant
  6. Persons under guardianship
  7. Subjects deemed unable to comply with study and/or follow-up procedures.
  8. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity

Information from the National Library of Medicine

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): NCT02179489


Contacts
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Contact: Lifeng Sun, MD 86-571-87784760 sunlifeng@zju.edu.cn

Locations
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China, Fujian
Union Hospital Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350001
Contact: Pan Chi, MD         
Principal Investigator: Chi Pan, MD         
China, Liaoning
Liaoning Cancer Hospital Recruiting
Shenyang, Liaoning, China, 110042
Principal Investigator: Chun Song, M.D.         
China, Shanghai
Zhongshan Hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Principal Investigator: Jianmin Xu, M.D.         
China, Zhejiang
The First Affiliated Hospital of College of Medicine Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Principal Investigator: Jianjiang Lin, M.D.         
Second Affiliated Hospitalof Zhejiang University School of Medicine Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Ke-Feng Ding, PhD/MD    86-571-87784827    dingkefeng@zju.edu.cn   
Principal Investigator: Ke-Feng Ding, PhD/MD         
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310016
Principal Investigator: Xuefeng Huang, M.D.         
Jinhua People's Hospital Recruiting
Jinhua, Zhejiang, China, 321000
Principal Investigator: Jinlin Du, M.D.         
People's Hospital of Shaoxing Recruiting
Shaoxing, Zhejiang, China, 312000
Contact: Xiao-Jiang Ying, MD    0575-88229151    lg_sx@sina.com   
Sub-Investigator: Xiao-Jiang Ying, MD         
Yuyao People's Hospital Recruiting
Yuyao, Zhejiang, China, 315400
Principal Investigator: Genhai Li, M.D.         
Sponsors and Collaborators
Zhejiang University
Investigators
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Principal Investigator: Kefeng Ding, Prof. Second Affiliated Hospital, School of Medicine, Zhejiang University

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Responsible Party: Ding Ke-Feng, Prof., Zhejiang University
ClinicalTrials.gov Identifier: NCT02179489     History of Changes
Other Study ID Numbers: CRCCZ-C01
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Keywords provided by Ding Ke-Feng, Zhejiang University:
Peritoneal carcinomatosis
HIPEC
controlled clinical trial
colorectal cancer
Additional relevant MeSH terms:
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Carcinoma
Peritoneal Neoplasms
Colorectal Neoplasms
Krukenberg Tumor
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma, Signet Ring Cell
Adenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous