Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia
28. januar 2019 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
50
Fase
- Fase 2
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Zhen Zhang, MD, Fudan University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. februar 2019
Primær færdiggørelse (Forventet)
1. september 2019
Studieafslutning (Forventet)
1. februar 2020
Datoer for studieregistrering
Først indsendt
19. januar 2019
Først indsendt, der opfyldte QC-kriterier
28. januar 2019
Først opslået (Faktiske)
30. januar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. januar 2019
Sidst verificeret
1. januar 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- Neoplasmer
- Neoplasmer efter sted
- Sygdomsegenskaber
- Hæmatologiske sygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Blodpladeforstyrrelser
- Kolorektale neoplasmer
- Tilbagevenden
- Trombocytopeni
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Topoisomerasehæmmere
- Topoisomerase I-hæmmere
- Folinsyreantagonister
- Irinotecan
- Raltitrexed
Andre undersøgelses-id-numre
- FDRT-009
Plan for individuelle deltagerdata (IPD)
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