Consolidative Radiotherapy Plus Maintenance Chemotherapy for Metastatic Colorectal Cancer

NCT03142282 | Unknown Phase 2 DMC

• 1 other identifier: MCRC-LC1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized phase II trial of maintenance chemotherapy versus consolidative radiotherapy plus maintenance chemotherapy for patients with unresectable metastatic colorectal cancer (MCRC).

Conditions

Metastatic Colorectal Cancer; Radiotherapy

Keywords

maintenance treatment

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Evaluate the effect of consolidative radiotherapy with or without maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival

  2 years

Secondary Outcomes (3)

• Actuarial rate in-field local control

  2 years

• Toxicities

  2 years

• Overall survival

  5 years

Study Arms (2)

Maintenance chemotherapy

ACTIVE COMPARATOR

FDA approved drugs for the study population: Bevacizumab, Xeloda

Drug: maintenance chemotherapy

Radiotherapy

EXPERIMENTAL

consolidative radiotherapy plus maintenance chemotherapy

Radiation: Consolidative Radiotherapy

Interventions

maintenance chemotherapy DRUG

National Comprehensive Cancer Network (NCCN) or European Society for Medical Oncology (ESMO) suggested maintenance chemotherapy regimens: xeloda, bevacizumab

Maintenance chemotherapy

Consolidative Radiotherapy RADIATION

Stereotacticbodyradiationtherapy (SBRT) or intensity modulated radiation therapy (IMRT) for metastatic sites (less than 5)

Radiotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have biopsy proven unresectable MCRC.
• Patients must have received induction chemotherapy for 3-6 months, and achieved stable disease or a partial response.
• Age ≥ 18 years
• Patients must have measurable disease at baseline.
• Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy.
• Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
• Patients must have a Karnofsky Performance Scores (KPS) \>60
• Aspartate aminotransferase, alanine aminotransferase \& Alkaline phosphates must be ≤ 2.5 times the upper limit of normal (ULN). 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 should have adequate renal function (serum creatinine ≤1.5 times the ULN).
• Females of childbearing potential should have a negative pregnancy test.
• Patients who would be receiving radiation for lung lesions who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1 litre.
• Patients must provide verbal and written informed consent to participate in the study.
• Total bilirubin: within normal institutional limits

You may not qualify if:

• Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
• Patients with serious, uncontrolled, concurrent infection(s).
• Significant weight loss (\>10%) in the prior 3 months.
• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
• Patients with more than 5 discrete metastatic lesions.
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
• Unwillingness to participate or inability to comply with the protocol for the duration of the study.
• Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study

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)

• Van Cutsem E, Cervantes A, Adam R, Sobrero A, Van Krieken JH, Aderka D, Aranda Aguilar E, Bardelli A, Benson A, Bodoky G, Ciardiello F, D'Hoore A, Diaz-Rubio E, Douillard JY, Ducreux M, Falcone A, Grothey A, Gruenberger T, Haustermans K, Heinemann V, Hoff P, Kohne CH, Labianca R, Laurent-Puig P, Ma B, Maughan T, Muro K, Normanno N, Osterlund P, Oyen WJ, Papamichael D, Pentheroudakis G, Pfeiffer P, Price TJ, Punt C, Ricke J, Roth A, Salazar R, Scheithauer W, Schmoll HJ, Tabernero J, Taieb J, Tejpar S, Wasan H, Yoshino T, Zaanan A, Arnold D. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016 Aug;27(8):1386-422. doi: 10.1093/annonc/mdw235. Epub 2016 Jul 5.

  PMID: 27380959 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

Maintenance Chemotherapy

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)

Drug Therapy; Therapeutics

Study Officials

• Tao Zhang, MD,PHD

  Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology , Wuhan 430022, China.

  STUDY CHAIR

Central Study Contacts

Tao Zhang, MD,PHD

CONTACT

862785871982; 1277577866@qq.com

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: Cancer Center

Model Details: Radiation: SBRT or IMRT Drug: Maintenance chemotherapy

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 5, 2017
• Study Start: January 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2024
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)