Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis (IPHC)

Cytoreductive Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy for the Treatment of Peritoneal Carcinomatosis From Gastrointestinal Cancer: an Open Label, Randomized, Prospective, Phase 2 Clinical Trial

OBJECTIVES:

• Determine response and survival of patients with peritoneal carcinomatosis treated with cytoreductive surgery plus intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
• Assess the quality of life of patients treated with this regimen.

OUTLINE: Patients are randomized into IPHC group and control group. In the former group, the patients undergo cytoreductive surgery plus intraoperative hyperthermic peritoneal perfusion with cisplatin and mitomycin over 60 minutes. Patients in the control group just underwent routine cytoreductive surgery.

All patients in both groups receive the standard conventional chemotherapy after surgery.

Quality of life is assessed at study initiation, at 1, 3, 6 months. Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for up to 3 years.

Study Overview

• Status: Unknown
• Conditions: Stomach Neoplasms; Neoplasm Metastasis; Colorectal Neoplasms; Mesothelioma
• Intervention / Treatment: Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin; Procedure: cytoreductive surgery

Detailed Description

DISEASE CHARACTERISTICS:

• Histologically confirmed peritoneal carcinomatosis with the following histologies:
• Primary peritoneal mesothelioma
• Adenocarcinoma of gastrointestinal tract origin
• Confined to peritoneal cavity
• Tumor mass could be debulked to less than 2.5 cm in diameter per tumor deposit
• Must not have failed prior intraperitoneal platinum therapy
• Treatment failure is defined as radiographic evidence of disease progression on 2 consecutive CT scans within 3 months after therapy

PATIENT CHARACTERISTICS:

Age:

- 20 to 70 years old

Performance status:

- KPS>50

Life expectancy:

- More than 8 weeks

Hematopoietic:

• WBC at least 3,500/mm^3
• Platelet count at least 80,000/mm^3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST and ALT no greater than 2 times ULN
• Liver enzymes no greater than 2 times ULN

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No significant irreversible cardiac ischemia
• No significant changes in ECG recording

Pulmonary:

• FEV_1 at least 1.2 liters
• Maximum voluntary ventilation at least 50% expected

Other:

• Not pregnant or nursing
• Negative pregnancy test
• No concurrent medical problems that would preclude surgery

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yan Li, M.D., Ph.D; Phone Number: +86-27-62337478; Email: liyansd2@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University
      • Contact: Yan Li, M.D., Ph.D; Phone Number: 3152 +86-27-67813152; Email: liyansd2@163.com
      • Contact: Yonemura Yutaka, M.D., Ph.D; Phone Number: +81-072-433-2131; Email: y.yonemura@coda.ocn.ne.jp
      • Sub-Investigator: Guo-Liang Yang, M.D
      • Sub-Investigator: Fu-Lin Cheng, M.D.
      • Principal Investigator: Yan Li, M.D., Ph.D
      • Sub-Investigator: Mao-Hui Feng, M.D., Ph.D
      • Sub-Investigator: Shibo Masaya, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Gastric cancer or colorectal cancer with peritoneal carcinomatosis
• Gastric cancer or colorectal cancer with malignant ascites
• Karnofsky Performance Scale(KPS)>50

Exclusion Criteria:

• Age less than 20 years old, or beyond 70 years old
• Any lung metastasis, liver metastasis, or prominent retroperitoneal lymph node metastasis
• Bilirubin greater than 3 times upper limit of normal (ULN)
• AST and ALT greater than 5 times ULN
• Liver enzymes greater than 3 times ULN

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy.	Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin; Immediately after the cytoreductive surgery, cisplatin and mitomycin C dissolved in 12,000 ml of normal saline heated to 42 degrees celsius is infused into the abdominal cavity for a sustained hyperthermic intraperitoneal chemotherapy for 60 to 90 minutes.; Other Names: HIPEC
Active Comparator: B; cytoreductive surgery alone, postoperative chemotherapy.	Procedure: cytoreductive surgery; the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival time	from operation to death due to cancer recurrence

Secondary Outcome Measures

Outcome Measure	Time Frame
perioperative morbidity and mortality	Within 30 days postoperation

Collaborators and Investigators

• Sponsor: Wuhan University
• Collaborators: NPO Organization to Support Peritoneal Dissemination Treatment; Kishiwada Tokushukai Hospital; Kusatsu General Hopital; Ikeda Hospital
• Investigators: Principal Investigator: Yan Li, M.D., Ph.D, Cancer Center of Wuhan University; Principal Investigator: Yonemura Yutaka, MD, PhD, NPO Organization to Support Peritoneal Dissemination Treatment

Publications and helpful links

General Publications

• Yang XJ, Li Y, al-shammaa Hassan AH, Yang GL, Liu SY, Lu YL, Zhang JW, Yonemura Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival in selected patients with peritoneal carcinomatosis from abdominal and pelvic malignancies: results of 21 cases. Ann Surg Oncol. 2009 Feb;16(2):345-51. doi: 10.1245/s10434-008-0226-2. Epub 2008 Nov 19.
• Wu HT, Yang XJ, Huang CQ, Sun JH, Ji ZH, Peng KW, Zhang Q, Li Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies. World J Surg Oncol. 2016 Sep 15;14(1):246. doi: 10.1186/s12957-016-1004-4.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: March 29, 2007
• First Submitted That Met QC Criteria: March 29, 2007
• First Posted (Estimate): March 30, 2007

Study Record Updates

• Last Update Posted (Estimate): February 13, 2009
• Last Update Submitted That Met QC Criteria: February 12, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: cisplatin; colorectal cancer; gastric cancer; peritoneal carcinomatosis; mitomycin
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Abdominal Neoplasms; Adenoma; Neoplasms, Mesothelial; Neoplasms; Stomach Neoplasms; Carcinoma; Colorectal Neoplasms; Neoplasm Metastasis; Peritoneal Neoplasms; Mesothelioma; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Cisplatin; Mitomycins; Mitomycin
• Other Study ID Numbers: WUCC-0701