Clinical trial NCT00454519: Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Mesothelioma
Keywords: peritoneal carcinomatosis
cisplatin
mitomycin
gastric cancer
colorectal cancer
Lead sponsor: Wuhan University
Sponsor class: OTHER
Collaborators: name: NPO Organization to Support Peritoneal Dissemination Treatment
name: Kishiwada Tokushukai Hospital
name: Kusatsu General Hopital
name: Ikeda Hospital
First posted: 2007-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: overall survival time
timeFrame: from operation to death due to cancer recurrence
Secondary outcomes:
measure: perioperative morbidity and mortality
timeFrame: Within 30 days postoperation
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Cancer Center of Wuhan University
name: Yan Li, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: NPO Organization to Support Peritoneal Dissemination Treatment
name: Yonemura Yutaka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.