NCT03823079

Brief Summary

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.

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
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_2

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

January 19, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

January 19, 2019

Last Update Submit

January 28, 2019

Conditions

Recurrent Colorectal CarcinomaThrombopenia

Keywords

Recombinant human interleukin-11Recombinant human thrombopoietin

Outcome Measures

Primary Outcomes (2)

  • the rate of recovery of platelet accounts

    From date of chemoradiation until the date of first documented recovery, assessed up to 6 months

  • the duration after returning to normal

    From date of first documented recovery until the date of first documented decrease of platelet accounts, assessed up to 6 months

Secondary Outcomes (4)

  • cycles of concurrent chemotherapy patients received during radiotherapy

    through chemoradiation, an average of 5 weeks

  • change of participant quality of life during treatment as assessed by EORTC-quality of life questionnaire-C30

    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

    at the beginning and the end of chemoradiation.

  • the rate of pathological complete response.

    Surgery scheduled 6-8 weeks after the end of chemoradiation

Study Arms (2)

rhTPO arm

EXPERIMENTAL

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

Drug: rhTPODrug: irinotecanDrug: RaltitrexedRadiation: radiotherapy

rhIL-11 arm

ACTIVE COMPARATOR

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

Drug: irinotecanDrug: RaltitrexedRadiation: radiotherapyDrug: rhIL-11

Interventions

rhTPODRUG

rhTPO 300u/kg, subcutaneous injection, qd

rhTPO arm
irinotecanDRUG

80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)

rhIL-11 armrhTPO arm
RaltitrexedDRUG

3mg/m2 q3w

rhIL-11 armrhTPO arm
radiotherapyRADIATION

in the use of intensity-modulated radiotherapy (IMRT) technology, the dose is judged according to the tumor site and radiotherapy purpose.

rhIL-11 armrhTPO arm
rhIL-11DRUG

rhIL-11 50ug/kg, subcutaneous injection, qd

rhIL-11 arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsThrombocytopenia

Interventions

IrinotecanraltitrexedRadiotherapyoprelvekin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsTherapeutics

Study Officials

  • Zhen Zhang, MD

    Fudan University

    STUDY CHAIR

Central Study Contacts

Ji Zhu, MD

CONTACT

+86-2164175590leo.zhu@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 19, 2019

First Posted

January 30, 2019

Study Start

February 1, 2019

Primary Completion

September 1, 2019

Study Completion

February 1, 2020

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share