A Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis

NCT01269229 | Completed Phase 2 DMC

• 1 other identifier: 4-2009-0522
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. The subject should have the pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis. This trial contributes to save the time for decreasing primary tumor in rectal and metastasis cancer to whole body after short course radiotherapy.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• complete resection (R0) rate for rectal and liver lesions.

  Complete resection (R0 resection) is defined as no residual cancer cells in the resection margn both primary recal mass and liver metastases after simultaneous surgical resection.

  after surgical resection

Secondary Outcomes (4)

• Response rate (RECIST V1.0)

  every 4 cycles

• Overall survival rate

  participants will be followed until death

• Progression free survival time

  participants will be followed until disease progression or death

• Toxicity profile

  participants will be followed until disease progression or death

Interventions

folfox DRUG

FOLFOX: Day1- Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, 5-FU 400mg/m2 IV bolus -\> 2400mg/m2 46hrs continuous

short course Radiotherapy RADIATION

After FOLFOX 4cycle, subject have short course RTx 5Gy at once this should be continuing for 5days so that subject should have 25Gy within 5days. Then, subjects have another 4 cycle of FOLFOX and evaluate cancer for resection.

Eligibility Criteria

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

You may qualify if:

• Subject whom should have the pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.
• Over 18 years
• ECOG 0-1
• Proper organ function (hepatic transaminases : \< ULN ⅹ5, Bilirubin: \< ULNⅹ2, creatinine (serum): \< ULNⅹ 1.5, PLT \> 100,000Ul, ANC \> 1,500/Ul
• more than one target lesion (standard by RECIST 1.0)
• Who should sign on the Informed consent form before participate the trial.

You may not qualify if:

• Metastasis in other organ except liver (No matter whether have resection or not)
• Chronic active hepatitis or cirrhosis
• History of treatment for colorectal cancer
• Subject pregnant or breast feeding
• Uncontrolled disease (eg. infection, hypertension, heart failure, Myocardial Infarction within 6months)
• Have been used FOLFOX as an adjuvant therapy
• Have had adjuvant therapy within 6months
• Uncontrolled peripheral nerve infection
• Alcoholic or drug addict
• Subject currently is enrolled in or ≤30 days from ending other clinical trial.
• History of other type of cancer except resolved from skin cancer and cervical cancer.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: January 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

KR (1)