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

Rectal Cancer Clinical Trial

Official title:

A Phase 2 Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269229
• Other study ID #: 4-2009-0522
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2011
• Last updated: September 5, 2016
• Start date: January 2010
• Est. completion date: April 2015

Study information

• Verified date: September 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 ?5, Bilirubin: < ULN?2, creatinine (serum): < ULN? 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Radiation:
• short course Radiotherapy
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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Response rate (RECIST V1.0)		every 4 cycles	No
Secondary	Overall survival rate		participants will be followed until death	No
Secondary	Progression free survival time		participants will be followed until disease progression or death	No
Secondary	Toxicity profile		participants will be followed until disease progression or death	No