The Effect of Prophylactic TPO Combined with BMS-IMRT to Esophageal Cancer Patients

NCT05944809 | Completed Phase 2

• 1 other identifier: NCC2818
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to explore the protective effect of prophylactic TPO combined with bone marrow sparing (BMS)-IMRT in patients with esophageal cancer undergoing concurrent chemoradiotherapy. The main purpose is to reduce the incidence of all grades of thrombocytopenia from 35% to less than 10% by the intervention of study. Participants will initiate concurrent chemoradiotherapy within 2 weeks after enrollment,and they will receive subcutaneous injection of recombinant human thrombopoietin (rhTPO) 15000U once a week during the radiotherapy.

Conditions

Esophageal Cancer; Intensity-modulated Radiation Therapy; Concurrent Chemoradiotherapy; Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• The highest grade of thrombocytopenia (CTCAE 4.0) during the radiotherapy and 1 month after the radiotherapy.

  For esophageal cancer patients, Grade 1-4 thrombocytopenia is considered as endpoints.

  From start of radiotherapy and 1 month after the radiotherapy.

Secondary Outcomes (4)

• Physical dosimetry of active bone marrow in BMS radiotherapy plan.

  The first day of radiotherapy.

• Conformity of BMS IMRT/VMAT (Volumetric Modulated Arc Therapy，VMAT) plan

  The first day of radiotherapy.

• Homogeneity of IMRT/VMAT (Volumetric Modulated Arc Therapy，VMAT) plan

  The first day of radiotherapy.

• The highest grade of leukopenia, neutropenia,anemia (CTCAE 4.0) during the radiotherapy and 1 month after the radiotherapy.

  From start of radiotherapy and 1 month after the radiotherapy.

Study Arms (1)

prophylactic TPO

EXPERIMENTAL

Prophylactic TPO combined with BMS-IMRT in the esophageal cancer patients undergoing concurrent chemoradiotherapy

Drug: rhTPO

Interventions

rhTPO DRUG

Standard treatment options: Radiotherapy: 95% planning target volume （planning target volume，PTV） ≥45Gy(without simultaneous boost). Concurrent chemotherapy: Weekly regimen: paclitaxel 50mg/m2 d1, nedaplatin/cisplatin 25 mg/m2d1, a total of 5 cycles. Three weeks regimen: paclitaxel 135-175mg/m2 d1, nedaplatin/cisplatin 80mg/m2, a total of 2 cycles. The active bone marrow was determined by magnetic resonance（magnetic resonance，MR）, and the dose limits are: V5\<95%,V10\<85%,V20\<60%，V30\<40%；95%PTV\>45Gy. rhTPO，15000U ih. qw(during the radiotherapy course)

Also known as: BMS-IMRT, concurrent chemoradiotherapy

prophylactic TPO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years and less than or equal to 75 years
• Histopathologically confirmed esophageal squamous/adenocarcinoma, clinical stage I-IV A (according to the 7th edition of AJCC（American Joint Committee on Cancer） 2010; Concurrent chemoradiotherapy (≥45Gy) was planned (regardless of whether the patient had received induction adjuvant chemotherapy).
• Karnofsky performance status score ≥80 ·;
• Life expectancy \>6 months;
• Meet the following laboratory diagnostic criteria:
• Hemoglobin ≥120g/L, white blood cell ≥4.0×109/L, Neutrophil ≥2.0×109/L, platelet ≥100×109/L;
• Participators had not used granulocyte colony-stimulating factor and thrombopoietin within 3 weeks before enrollment.

You may not qualify if:

• A history of malignancy at other sites, excluding curable non-melanotic skin cancer and cervical carcinoma in situ;
• Previous radiotherapy to the chest;
• Patients with existing or suspected (thoracolumbar and pelvic) bone marrow or bone metastases, or a history of bone trauma in this region within 4 weeks;
• Allergy to Gadolinium-based contrast agent;
• Patients with active infection, or combined with rheumatic immune disease, long-term chronic infection, acute infection, etc., so that the body is in an inflammatory state; Blood system diseases with hematopoietic dysfunction;

Sponsors & Collaborators

• JIANYANG WANG: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

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MeSH Terms

Conditions

Esophageal Neoplasms; Thrombocytopenia

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Jianyang Wang, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients are planned to receive concurrent BMS thoracic radiotherapy (\>45Gy, 1.8Gy per fraction), chemotherapy (five cycles of weekly intravenous paclitaxel \[50 mg/m²\] and cisplatin/nedaplatin \[25 mg/m²\], or two cycles of intravenous paclitaxel \[135-175 mg/m²\] and cisplatin/nedaplatin \[80 mg/m²\]) , and rhTPO，15000U ih. qw(during the radiotherapy)

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 13, 2023
• Study Start: July 20, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)