NCT01758666

Brief Summary

At present, the most effective drugs to osteosarcoma include ADM,DDP,,HD-MTX,IFO and so on.The effective rate of single drug was about 30%, and if the chemotherapy contains HD-MTX, the survival rate can reach about 60%, so the HD-MTX is the most important component in patients of osteosarcoma. Studies have shown that, MTX efficacy and adverse reactions were associated with blood concentration level and duration, selecting the right time and dose to give CF is the critical point.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

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

August 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2012

Enrollment Period

4.2 years

First QC Date

August 30, 2012

Last Update Submit

December 21, 2015

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

  • blood concentration of MTX

    up to 3 years

Secondary Outcomes (1)

  • other adverse reaction

    up to 3 years

Study Arms (1)

Methotrexate and Calcium folinate

EXPERIMENTAL
Drug: Methotrexate,Calcium folinate

Interventions

Methotrexate,Calcium folinateDRUG
Methotrexate and Calcium folinate

Eligibility Criteria

Age12 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Proved by pathology in 60 cases of osteosarcoma patients
  • PS ≤ 2, survival period is more than 6 months
  • Normal function of liver and kidney
  • No chemotherapy contraindication, patients treat with high dose methotrexate
  • Get signed written informed consent form
  • Have a good compliance with take blood and follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteosarcoma

Interventions

MethotrexateLeucovorin

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidCoenzymesEnzymes and Coenzymes

Study Officials

  • Chen Wang

    Tianjin Medical University Cancer Institute and Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2012

First Posted

January 1, 2013

Study Start

September 1, 2012

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 22, 2015

Record last verified: 2012-12