NCT02948985

Brief Summary

Evaluation of individual peripheral blood circulating tumor cells combined with tumor marker detection of efficacy of chemotherapy in patients with advanced colorectal cancer: A observational clinical trial

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

2.5 years

First QC Date

October 27, 2016

Last Update Submit

October 31, 2016

Conditions

Colorectal Cancer Metastatic

Keywords

Metastatic colorectal cancerCetuximabCTCsct DNA

Outcome Measures

Primary Outcomes (1)

  • Correlation of RAS status on CTCs with clinical outcomes

    To evaluate the correlation of CTCs and their RAS status to the clinical outcomes

    3 years

Secondary Outcomes (1)

  • Correlation of mutant gene in ctDNA with cetuximab resistance.

    3 years

Study Arms (1)

RAS and B-raf wild type mCRC

patients with histologically confirmed RAS and B-raf wild type mCRC treated with FOLFIRI±cetuximab

Other: treated with FOLFIRI±cetuximab

Interventions

treated with FOLFIRI±cetuximabOTHER

Peripheral blood samples of 10 mL were collected from the patients for CTCs analysis and tumor marker in every cycle D0 and D8. Tumor response evaluation will be performed after four cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastatic organ, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.The correlation of the RAS status on CTCs and the mutant gene in ctDNA to the therapeutic response will be evaluated.

RAS and B-raf wild type mCRC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with histologically confirmed RAS and B-raf wild type mCRC treated withFOLFIRI±cetuximab

You may qualify if:

  • Having signed informed consent
  • Age18-75 years old
  • Histologically confirmed mCRC
  • First metastatic,unresectable
  • RAS and B-raf wild type
  • At least one measurable disease according to the RECIST criteria by CT/MRI
  • Expected survival time≥12 weeks
  • ECOG PS 0-1
  • Adequate bone marrow, hepatic, renal and metabolic function

You may not qualify if:

  • Received chemotherapy for CRC previously, except adjuvant chemotherapy end of adjuvant chemotherapy≥9m(contain irinotecan) or ≥9m(not contain irinotecan) before the study.
  • Surgery or radiotherapy ≤30 days before the study.
  • Received anti-EGFR,anti-VEGF or other signaling pathway inhibitor previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.

    PMID: 15175435RESULT

  • Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.

    PMID: 19339720RESULT

  • Bokemeyer C, Van Cutsem E, Rougier P, Ciardiello F, Heeger S, Schlichting M, Celik I, Kohne CH. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer: pooled analysis of the CRYSTAL and OPUS randomised clinical trials. Eur J Cancer. 2012 Jul;48(10):1466-75. doi: 10.1016/j.ejca.2012.02.057. Epub 2012 Mar 23.

    PMID: 22446022RESULT

  • Heinemann V, von Weikersthal LF, Decker T, Kiani A, Vehling-Kaiser U, Al-Batran SE, Heintges T, Lerchenmuller C, Kahl C, Seipelt G, Kullmann F, Stauch M, Scheithauer W, Hielscher J, Scholz M, Muller S, Link H, Niederle N, Rost A, Hoffkes HG, Moehler M, Lindig RU, Modest DP, Rossius L, Kirchner T, Jung A, Stintzing S. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Sep;15(10):1065-75. doi: 10.1016/S1470-2045(14)70330-4. Epub 2014 Jul 31.

    PMID: 25088940RESULT

  • Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004 Jul 22;351(4):337-45. doi: 10.1056/NEJMoa033025.

    PMID: 15269313RESULT

  • Saltz LB, Meropol NJ, Loehrer PJ Sr, Needle MN, Kopit J, Mayer RJ. Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol. 2004 Apr 1;22(7):1201-8. doi: 10.1200/JCO.2004.10.182. Epub 2004 Mar 1.

    PMID: 14993230RESULT

  • Sorich MJ, Wiese MD, Rowland A, Kichenadasse G, McKinnon RA, Karapetis CS. Extended RAS mutations and anti-EGFR monoclonal antibody survival benefit in metastatic colorectal cancer: a meta-analysis of randomized, controlled trials. Ann Oncol. 2015 Jan;26(1):13-21. doi: 10.1093/annonc/mdu378. Epub 2014 Aug 12.

    PMID: 25115304RESULT

  • Tol J, Nagtegaal ID, Punt CJ. BRAF mutation in metastatic colorectal cancer. N Engl J Med. 2009 Jul 2;361(1):98-9. doi: 10.1056/NEJMc0904160. No abstract available.

    PMID: 19571295RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples of 10 mL were collected from the patients for ctDNA and CTCs analysis

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Wang Xingpeng, MD PHD

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Central Study Contacts

Li Qi, MD PHD

CONTACT

+8618121288167Leeqi2001@hotmail.com

Zhang Haiyan, MD

CONTACT

+8613611956117Zhymmx@sina.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive director of cancer center

Study Record Dates

First Submitted

October 27, 2016

First Posted

October 31, 2016

Study Start

January 1, 2017

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

November 1, 2016

Record last verified: 2016-10