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

NCT ID: NCT03823079

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-02-01

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.

Conditions

Recurrent Colorectal Carcinoma; Thrombopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

rhTPO

Intervention Type: DRUG

rhTPO 300u/kg, subcutaneous injection, qd

irinotecan

Intervention Type: DRUG

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

Raltitrexed

Intervention Type: DRUG

3mg/m2 q3w

radiotherapy

Intervention Type: RADIATION

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

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

Group Type: ACTIVE_COMPARATOR

irinotecan

Intervention Type: DRUG

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

Raltitrexed

Intervention Type: DRUG

3mg/m2 q3w

radiotherapy

Intervention Type: RADIATION

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

rhIL-11

Intervention Type: DRUG

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

Interventions

rhTPO

rhTPO 300u/kg, subcutaneous injection, qd

Intervention Type: DRUG

irinotecan

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

Intervention Type: DRUG

Raltitrexed

3mg/m2 q3w

Intervention Type: DRUG

radiotherapy

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

Intervention Type: RADIATION

rhIL-11

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhu Ji

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhen Zhang, MD

Role: STUDY_CHAIR

Fudan University

Central Contacts

Ji Zhu, MD

Role: CONTACT

leo.zhu@126.com

+86-2164175590 ext. 81607

Other Identifiers

FDRT-009

Identifier Type: -

Identifier Source: org_study_id