Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation

NCT03135652 | Withdrawn Phase 2

• 1 other identifier: CRLM-AR1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized phase II trial to evaluate the efficacy of adjuvant consolidative radiotherapy in colorectal cancer liver metastasis (CRLM) patients after chemotherapy combined with surgical resection or radiofrequency ablation of liver lesions.

Conditions

Radiotherapy; Colorectal Cancer; Liver Metastases

Keywords

Radiotherapy; Colorectal Cancer; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  Evaluate the effect of consolidative SBRT of liver lesions versus observation on disease free survival

  2 years

Secondary Outcomes (3)

• Overall survival

  5 years

• Intrahepatic disease free survival

  2 years

• Toxicities

  2 years

Study Arms (2)

chemoradiotherapy

EXPERIMENTAL

radiotherapy: adjuvant SBRT of liver lesions; chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment

Radiation: adjuvant SBRT; Drug: Chemotherapy

chemotherapy

ACTIVE COMPARATOR

chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment

Drug: Chemotherapy

Interventions

adjuvant SBRT RADIATION

adjuvant SBRT of liver lesions

Also known as: radiotherapy

chemoradiotherapy

Chemotherapy DRUG

mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment

Also known as: neoadjuvant chemotherapy and adjuvant chemotherapy

chemoradiotherapy; chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven unresectable metastatic colorectal cancer (CRC)
• Primary resection of colorectal cancer (CRC)
• Age≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Absence of evidence of extra-hepatic diseases
• to 3 liver metastases with an individual maximum diameter of up to 5 cm
• Metastatic liver lesions receiving R0 or R1 resection or radiofrequency ablation with visible tumor bed
• Aspartate aminotransferase, alanine aminotransferase \& alkaline phosphates must be ≤ 2.5 times of the upper limit of normal. Total bilirubin must be within the limit of normal.
• Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3.
• Patients must provide verbal and written informed consent to participate in the study.
• Absence of any severe pulmonary or cardiac diseases

You may not qualify if:

• Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
• Patients who are pregnant
• Patients with severe organ dysfunction
• History of liver radiotherapy
• Unwillingness to participate or inability to comply with the protocol for the duration of the study
• Participation in any investigational drug study within 3 months preceding the start of study treatment
• Patients not suitable to take part in clinical trials judged by researches

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Related Publications (2)

• Nordlinger B, Guiguet M, Vaillant JC, Balladur P, Boudjema K, Bachellier P, Jaeck D. Surgical resection of colorectal carcinoma metastases to the liver. A prognostic scoring system to improve case selection, based on 1568 patients. Association Francaise de Chirurgie. Cancer. 1996 Apr 1;77(7):1254-62.

  PMID: 8608500 RESULT

• Gomez DR, Blumenschein GR Jr, Lee JJ, Hernandez M, Ye R, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Gibbons DL, Karam JA, Kavanagh BD, Tang C, Komaki R, Louie AV, Palma DA, Tsao AS, Sepesi B, William WN, Zhang J, Shi Q, Wang XS, Swisher SG, Heymach JV. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1672-1682. doi: 10.1016/S1470-2045(16)30532-0. Epub 2016 Oct 24.

  PMID: 27789196 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Radiotherapy; Drug Therapy; Neoadjuvant Therapy; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Combined Modality Therapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastrointestinal Oncology Department

Model Details: adjuvant radiotherapy:SBRT chemotherapy:mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: August 1, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

CN (1)