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Completed

NCT Number: NCT01269229

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: after surgical resection

    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.

Secondary outcomes

  1. Response rate (RECIST V1.0)

    Time frame: every 4 cycles

  2. Overall survival rate

    Time frame: participants will be followed until death

  3. Progression free survival time

    Time frame: participants will be followed until disease progression or death

  4. Toxicity profile

    Time frame: participants will be followed until disease progression or death

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 4, 2011
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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