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Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

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Yonsei University

Status and phase

Unknown
Phase 2

Conditions

Rectal Cancer, Metastatic

Treatments

Drug: chemotherapy
Radiation: radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03022734
4-2016-0410

Details and patient eligibility

About

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. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.

Enrollment

40 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis
  • over 19 years
  • Eastern Cooperative Oncology Group 0-1
  • Proper organ function
  • more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors 1.1)
  • Who should sign on the Informed consent form before participate the trial.

Exclusion criteria

  • Metastasis in other organ except liver
  • Chronic active hepatitis or cirrhosis
  • History of treatment for metastatic colorectal cancer
  • Subject pregnant or breast feeding
  • Uncontrolled disease
  • Have had adjuvant therapy
  • 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

chemotherapy with radiotherapy
Experimental group
Description:
Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy
Treatment:
Radiation: radiotherapy
Drug: chemotherapy

Trial contacts and locations

1

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Central trial contact

Sang Joon Shin

Data sourced from clinicaltrials.gov

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