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Consolidative Radiotherapy Plus Maintenance Chemotherapy for Metastatic Colorectal Cancer (MCRC-LC1)

Primary Purpose

Metastatic Colorectal Cancer, Radiotherapy

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

maintenance chemotherapy

Consolidative Radiotherapy

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring maintenance treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Maintenance chemotherapy

Radiotherapy

Arm Description

FDA approved drugs for the study population: Bevacizumab, Xeloda

consolidative radiotherapy plus maintenance chemotherapy

Outcomes

Primary Outcome Measures

Progression free survival

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

Secondary Outcome Measures

Actuarial rate in-field local control

To describe the actuarial rate in-field local control and rate of out-of-field disease progression

Toxicities

Acute toxicity was scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria during and up to 3 months after radiotherapy. Late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for the Research and Treatment of Cancer (EORTC) criteria.

Overall survival

To evaluate overall survival after consolidative radiotherapy followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.

Full Information

NCT ID

NCT03142282

First Posted

April 26, 2017

Last Updated

September 5, 2018

Sponsor

Wuhan Union Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT03142282

Brief Title

Consolidative Radiotherapy Plus Maintenance Chemotherapy for Metastatic Colorectal Cancer

Acronym

MCRC-LC1

Official Title

Maintenance Chemotherapy Versus Consolidative Radiotherapy Plus Maintenance Chemotherapy for Unresectable Metastatic Colorectal Cancer: A Randomized Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2019 (Anticipated)

Primary Completion Date

August 31, 2021 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

Prior to accrual on the trial, patients with unresectable metastatic colorectal cancer will be treated with palliative chemotherapy. And patients who achieve a partial response or stable disease by imaging criteria will receive maintenance chemotherapy. In our study, these group patients will be randomized to maintenance chemotherapy or consolidative radiotherapy to all sites of disease (followed by maintenance chemotherapy at the medical oncologist's discretion). Choices of palliative and maintenance chemotherapy will be determined by the medical oncologist based on clinical appropriateness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer, Radiotherapy

Keywords

maintenance treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Radiation: SBRT or IMRT Drug: Maintenance chemotherapy

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Maintenance chemotherapy

Arm Type

Active Comparator

Arm Description

FDA approved drugs for the study population: Bevacizumab, Xeloda

Arm Title

Radiotherapy

Arm Type

Experimental

Arm Description

consolidative radiotherapy plus maintenance chemotherapy

Intervention Type

Drug

Intervention Name(s)

maintenance chemotherapy

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Consolidative Radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression free survival

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Actuarial rate in-field local control

Description

To describe the actuarial rate in-field local control and rate of out-of-field disease progression

Time Frame

2 years

Title

Toxicities

Description

Time Frame

2 years

Title

Overall survival

Description

To evaluate overall survival after consolidative radiotherapy followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.

Time Frame

5 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tao Zhang, MD,PHD

Phone

862785871982

1277577866@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tao Zhang, MD,PHD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Wuhan

State/Province

Hubei

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tao Zhang, MD, PHD

Phone

862785871982

1277577866@qq.com

First Name & Middle Initial & Last Name & Degree

Zhenyu Lin, MD

Phone

15827130393

tojilin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27380959

Citation

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.

Results Reference

result

PubMed Identifier

27789196

Citation

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.

Results Reference

result

Learn more about this trial

Consolidative Radiotherapy Plus Maintenance Chemotherapy for Metastatic Colorectal Cancer

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