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Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia

Primary Purpose

Recurrent Colorectal Carcinoma, Thrombopenia

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

rhTPO

irinotecan

Raltitrexed

radiotherapy

rhIL-11

About this trial

This is an interventional treatment trial for Recurrent Colorectal Carcinoma focused on measuring Recombinant human interleukin-11, Recombinant human thrombopoietin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rhTPO arm

rhIL-11 arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

the rate of recovery of platelet accounts

the duration after returning to normal

Secondary Outcome Measures

cycles of concurrent chemotherapy patients received during radiotherapy

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

change of participant quality of life during treatment as assessed by EuroQol-5 dimensional (EQ-5D) questionnaire

the rate of pathological complete response.

pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.

Full Information

NCT ID

NCT03823079

First Posted

January 19, 2019

Last Updated

January 28, 2019

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03823079

Brief Title

Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2019 (Anticipated)

Primary Completion Date

September 1, 2019 (Anticipated)

Study Completion Date

February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Colorectal Carcinoma, Thrombopenia

Keywords

Recombinant human interleukin-11, Recombinant human thrombopoietin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

rhTPO arm

Arm Type

Experimental

Arm Description

Arm Title

rhIL-11 arm

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

rhTPO

Intervention Description

rhTPO 300u/kg, subcutaneous injection, qd

Intervention Type

Drug

Intervention Name(s)

irinotecan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Raltitrexed

Intervention Description

3mg/m2 q3w

Intervention Type

Radiation

Intervention Name(s)

radiotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

rhIL-11

Intervention Description

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

Primary Outcome Measure Information:

Title

the rate of recovery of platelet accounts

Time Frame

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

Title

the duration after returning to normal

Time Frame

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

Secondary Outcome Measure Information:

Title

cycles of concurrent chemotherapy patients received during radiotherapy

Time Frame

through chemoradiation, an average of 5 weeks

Title

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

Time Frame

at the beginning and the end of chemoradiation.

Title

change of participant quality of life during treatment as assessed by EuroQol-5 dimensional (EQ-5D) questionnaire

Time Frame

at the beginning and the end of chemoradiation.

Title

the rate of pathological complete response.

Description

pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.

Time Frame

Surgery scheduled 6-8 weeks after the end of chemoradiation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ji Zhu, MD

Phone

+86-2164175590

Ext

81607

leo.zhu@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhen Zhang, MD

Organizational Affiliation

Fudan University

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia

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