LOTCOL Study: Local Treatment of Colo-rectal Liver Met

NCT01867918 | Terminated

• 1 other identifier: 2012/1392 REK South East C
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will include colo-rectal cancer (CRC) patients starting last line of standard palliative chemotherapy. Eligible patients include patients with KRAS mutation starting line or KRAS wild type starting line treatment. Standard treatment today for these patients is chemotherapy only and median overall survival (OS) is about 10 months. The hypothesis is that local treatment in addition to systemic treatment will increase time to progression, progression free survival and overall survival compared to patients who receive systemic chemotherapy only. The investigators experience with local treatment of liver metastases in CRC patients is that side-effects of treatment in general are minor, although gastric bleeding have been observed after stereotactic body radiation therapy.

Conditions

Metastatic Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival from time of randomization

  6 months

Study Arms (2)

Cheomotherapy and local treatment

EXPERIMENTAL

Standard chemotherapy + local treatment

Procedure: Radiofrequency ablation, microwave, radiation therapy

Cheomotherapy

PLACEBO COMPARATOR

Standard chemotherapy

Drug: Standard Chemotherapy

Interventions

Radiofrequency ablation, microwave, radiation therapy PROCEDURE

Radiofrequency ablation Microwave ablation Radiation therapy

Cheomotherapy and local treatment

Standard Chemotherapy DRUG

Cheomotherapy

Eligibility Criteria

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

You may qualify if:

• Histologically verified adenocarcinoma of colon or rectum
• Ambulatory with an ECOG performance status 0-2
• At least 18 years of age
• Non-resectable liver metastases
• Progressive disease on or within 4 months after 1.line chemotherapy for KRAS mutant or after 2.line chemotherapy in KRAS wild type patients
• liver metastases with largest diameter of up to 6 cm on CT-scan
• Up to 20 lesions in liver with no more than 4 lesions larger than 4 cm
• The patients will start 2./3. line chemotherapy (KRAS mutant/KRAS wt)
• Laboratory values as the following:
• ANC ³ 1.5 x 109/L
• Platelets ³ 100 x 109/L
• Hb ³ 9g/dL
• Creatinine £ 2x upper limit of normal
• Bilirubin \< 2.0x the upper limit of normal
• ASAT and ALAT £ 5x the upper limit of normal

You may not qualify if:

• Previous treatment with 2. or 3. line chemotherapy (KRAS mutant/KRAS wt)
• History of prior metastatic disease the last 3 years
• History of CNS or bone metastases
• Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
• Largest liver mets \>6 cm, more than 4 liver lesions \>4 cm
• Pulmonary mets\>3 cm
• Lymph node mets \>2.5 cm
• Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
• Any reason why, in the opinion of the investigator, the patient should not participate.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, N-0310, Norway

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Radiofrequency Ablation; Microwaves; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Radio Waves; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Nonionizing

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

NO (1)