Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia
28. januar 2019 oppdatert av: Zhu Ji, Fudan University
A Randomized Phase II Study of Recombinant Human Thrombopoietin (Rh-TPO) and Recombinant Human Interleukin-11 (rhIL-11) for Recurrent Colorectal Cancer (CRC) Patients With Thrombocytopenia
This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
Most patients with recurrent CRC have undergone a six-month postoperative adjuvant chemotherapy with oxaliplatin plus fluorouracil.
Although the main dose-limiting side effect of oxaliplatin is neurotoxicity, with the widespread use of this drug, there are more and more reports that oxaliplatin is discontinued because of thrombocytopenia, which increases the risk of bleeding, rate of blood transfusion needs and length of stay.
On the other hand, patients undergoing pelvic radiotherapy may also experience significant bone marrow suppression because flat bones such as the tibia may be exposed to high doses radiation.
Low platelet counts is an urgent problem to be solved in order to give adequate quantitative radiotherapy.
This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia, thus providing more evidence in clinical practice.
Studietype
Intervensjonell
Registrering (Forventet)
50
Fase
- Fase 2
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- The primary tumor is colorectal cancer, histologically proved recurrence or metastasis disease, or pelvic relapse within 6 months after oxaliplatin-based adjuvant chemotherapy.
- Not suitable for re-use of oxaliplatin and fluorouracil.
- No medication history of irinotecan.
- Lesions evaluable, and has indications for radiotherapy.
- UGT1A1*28 gene phenotype is 6/6 or 6/7
- Karnofsky physical condition score ≥ 70
- Baseline platelet counts are 25-75×10^9/L, other bone marrow reserve and liver and kidney function meet the requirements of radiotherapy
- Able to follow the program during the study period
- Sign the informed consent
Exclusion Criteria:
- Pregnant or breastfeeding women
- Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
- If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
- Organ transplantation requires immunosuppressive therapy
- Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
- Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin ≥ 30g / L
- Anyone who is allergic to any research medication
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: rhTPO arm
rhTPO: 300 u/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal) Concurrent Chemoradiotherapy: Radiation: judged according to the tumor site and radiotherapy purpose. Irinotecan: 80 mg/m2 (UGT1A1*28 6/6) or 65 mg/m2 (UGT1A1*28 6/7) Raltitrexed: 3 mg/m2 q3w |
rhTPO 300u/kg, subcutaneous injection, qd
80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
3mg/m2 q3w
in the use of intensity-modulated radiotherapy (IMRT) technology, the dose is judged according to the tumor site and radiotherapy purpose.
|
|
Aktiv komparator: rhIL-11 arm
rhIL-11: 50 ug/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal) Concurrent Chemoradiotherapy: Radiation: judged according to the tumor site and radiotherapy purpose. Irinotecan: 80 mg/m2 (UGT1A1*28 6/6) or 65 mg/m2 (UGT1A1*28 6/7) Raltitrexed: 3 mg/m2 q3w |
80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
3mg/m2 q3w
in the use of intensity-modulated radiotherapy (IMRT) technology, the dose is judged according to the tumor site and radiotherapy purpose.
rhIL-11 50ug/kg, subcutaneous injection, qd
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
the rate of recovery of platelet accounts
Tidsramme: From date of chemoradiation until the date of first documented recovery, assessed up to 6 months
|
From date of chemoradiation until the date of first documented recovery, assessed up to 6 months
|
|
the duration after returning to normal
Tidsramme: From date of first documented recovery until the date of first documented decrease of platelet accounts, assessed up to 6 months
|
From date of first documented recovery until the date of first documented decrease of platelet accounts, assessed up to 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
cycles of concurrent chemotherapy patients received during radiotherapy
Tidsramme: through chemoradiation, an average of 5 weeks
|
through chemoradiation, an average of 5 weeks
|
|
|
change of participant quality of life during treatment as assessed by EORTC-quality of life questionnaire-C30
Tidsramme: at the beginning and the end of chemoradiation.
|
at the beginning and the end of chemoradiation.
|
|
|
change of participant quality of life during treatment as assessed by EuroQol-5 dimensional (EQ-5D) questionnaire
Tidsramme: at the beginning and the end of chemoradiation.
|
at the beginning and the end of chemoradiation.
|
|
|
the rate of pathological complete response.
Tidsramme: Surgery scheduled 6-8 weeks after the end of chemoradiation
|
pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.
|
Surgery scheduled 6-8 weeks after the end of chemoradiation
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Zhen Zhang, MD, Fudan University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. februar 2019
Primær fullføring (Forventet)
1. september 2019
Studiet fullført (Forventet)
1. februar 2020
Datoer for studieregistrering
Først innsendt
19. januar 2019
Først innsendt som oppfylte QC-kriteriene
28. januar 2019
Først lagt ut (Faktiske)
30. januar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. januar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. januar 2019
Sist bekreftet
1. januar 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- Neoplasmer
- Neoplasmer etter nettsted
- Sykdomsattributter
- Hematologiske sykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolonsykdommer
- Tarmsykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Blodplateforstyrrelser
- Kolorektale neoplasmer
- Tilbakefall
- Trombocytopeni
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Topoisomerasehemmere
- Topoisomerase I-hemmere
- Folsyreantagonister
- Irinotekan
- Raltitrexed
Andre studie-ID-numre
- FDRT-009
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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