A study to evaluate the efficacy and safety of combination therapy with pemetrexed and cisplatin after primary treatment in metastatic / recurrent soft tissue sarcoma

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0003542
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1.Histologically confirmed advanced bone and soft tissue sarcoma
2. Histologically confirmed advanced bone and soft tissue sarcoma with prior chemotherapy including anthracycline or ifosfamide : neoadjuvnat or adjuvant chemotherapy is counted as one regimen
2. Measurable or evaluable disease (RECIST 1.1.)
3. ECOG(Eastern Cooperative Oncology Group) performance status of 0-2
4. Adequate laboratory findings
5. more than 3 months of expected survival
6. Provision of written informed consent prior to any study procedure

Exclusion Criteria

1.Diagnosed with GIST(Gastrointestinal stromal tumor) or Kaposi sarcoma
2. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study’
3. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
4. Resectable lung metastases
5. Uncontrolled or active CNS(Central nervous system) metastasis and/or carcinomatous meningitis
6. Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
7. Uncontrolled medical conditions

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate that dose not progress from ther start of the drug to the 12th week

Secondary Outcome Measures

Name	Time	Method
Adverse event