Effectiveness of the Combined WLI and Hyperthermia for GI Cancer Liver Metastasis

NCT01963117 | Terminated Results

• 1 other identifier: SMC IRB 2013-06-040
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The standard treatment of unresectable liver metastasis in gastrointestinal tract cancer is chemotherapy, but considerable portion of the patients progressed and most of the liver is converted to metastatic tumor lesions. Significant quality of life decrement was detected in those patients, especially in patients suffered severe symptoms Several studies reported that whole liver RT (WLRT) can be used effectively to control severe symptoms from unresectable liver metastasis in gastrointestinal tract cancer patients. However, it is well known fact that the liver is a very sensitive to RT. Despite symptom palliation is obtained after 20 to 30 Gy RT but only in small subset of patients get local control. In this aspect, the combined with radiosensitizer with WLRT is considered to enhance RT effect to palliate symptom and control local tumor progression, and increase the quality of life ultimately. It is reported that hyperthermia is considered as the most valuable radiosensitizer in cancer treatment, theoretically. Based on those studies, we start this prospective study to investigate the effect of combination treatment of WLRT and hyperthermia on quality of life in the patients with unresectable chemoresistant liver metastasis from gastrointestinal tract cancer.

Conditions

Hyperthermia

Outcome Measures

Primary Outcomes (1)

• Time to Local Tumor Progression After Combined Hyperthermia and RT

  Local progression will be defined as more than 20% size increase of metastatic lesions or new metastatic lesion in liver. Time to local tumor progression will be measured from the date of RT start to the date of local progression or last follow-up visit.

  Patient will be evaluated after combined hyperthermia and RT until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 19 months.

Secondary Outcomes (5)

• Objective Response Rate of Combined Hyperthermia and RT

  Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.

• Change in the Grade of Quality of Life at 3 Months From That Before the Combined Hyperthermia and RT

  Quality of life will be ssessed at baseline and 3 months after combined hyperthemica and RT, data reported 3 months after combined hyperthemica and RT with grade from 1 to 4.

• Local Tumor Progression Free Survival Rate After Combined Hyperthermia and RT

  Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.

• Adverse Event After Combined Hyperthermia and RT.

  Adverse event will be evaluated at 3 month. The common terminology criteria for adverse events (CTCAE) version 4.0 will be used.

• Overall Survival Rate After Combined Hyperthermia and RT

  Pathient will be evaluated at 3 month after combined hyperthermia and RT.

Study Arms (1)

Combined hypertermia and RT

EXPERIMENTAL

Combined hypertermia and radiothearpy

Radiation: Combined hyperthermia and radiation therapy

Interventions

Combined hyperthermia and radiation therapy RADIATION

Combined hypertermia and RT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a diagnosis of pathologic proven gastrointestinal tract cancer
• Unresectable and unsuitable to other local modalities
• Not responded and/or unsuitable to chemotherapy
• Eastern Cooperative Oncology Group ECOG) performance status 0 to 3
• Assessment by colorectal tumor board (surgeon, radiation oncologist and medical oncologist participated)
• Age ≥ 20
• Agreement of study-specific informed consent
• Blood work requirements
• Absolute neutrophil count (ANC) ≥ 1,500 /mm3, Platelet ≥ 50,000/mm3, Hgb ≥ 8 g/dl
• Liver function test(LFT): Total bilirubin\<3.0 mg/dL, International normalized ratio(INR) \< 1.7, Albumin ≥ 2.8g/dL, Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT)\< 6 X normal
• Serum creatinine \< 1.5 X normal, or Creatinine clearance rate (CCr) ≥ 60 mL/min
• Child-Pugh score 10 or less within 1 week before WLI
• Childbearing potential woman, consent contraception at least 6 months
• Stable breathing more than 5 minutes

You may not qualify if:

• Life expectancy less than 8 weeks
• Pregnant and/or breastfeeding woman
• Previous upper abdominal RT history
• Uncontrolled ascites or hepatic encephalopathy
• Unstable respiration due to pleural effusion, chronic obstructive pulmonary disease COPD) etc

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Hyperthermia

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Professor
• Organization: Samsung Medical Center

hee.ro.park@gmail.com

82-2-3410-2612

Study Officials

• Hee Chul Park, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: October 16, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: April 1, 2015
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2014-08

Locations

KR (1)