Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

NCT03022734 | Unknown Phase 2

• 1 other identifier: 4-2016-0410
• Study Type: interventional
• Target: 40
• 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. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.

Conditions

Rectal Cancer, Metastatic

Outcome Measures

Primary Outcomes (1)

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

  after surgical resection, an average of 24 weeks

Secondary Outcomes (1)

• Response rate (RECIST V1.1)

  8 weeks

Study Arms (1)

chemotherapy with radiotherapy

EXPERIMENTAL

Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy

Drug: chemotherapy; Radiation: radiotherapy

Interventions

chemotherapy DRUG

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)

chemotherapy with radiotherapy

radiotherapy RADIATION

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

chemotherapy with radiotherapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasm Metastasis

Interventions

Drug Therapy; Radiotherapy

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Sang Joon Shin

CONTACT

82-2-2228-8130

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 16, 2017
• Study Start: September 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)