Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03022734

Enrollment

Registered

2017-01-16

Start date

2016-09-30

Completion date

2021-06-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer, Metastatic

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

Interventions

DRUGchemotherapy

cetuximab 250mg/m2 or bevacizumab 5mg/kg, FOLFOX (oxaliplatin 85mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2) or FOLFIRI (irinotecan 180mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2)

RADIATIONradiotherapy

After FOLFOX 4cycle, subject have short course radiotherapy 5Gy for 5 days.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
complete resection (R0) rate for rectal and liver lesions	after surgical resection, an average of 24 weeks

Secondary

Measure	Time frame
Response rate (RECIST V1.1)	8 weeks

Countries

South Korea

Contacts

Primary ContactSang Joon Shin

82-2-2228-8130

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026