Clinical Trials Directory

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UnknownNCT03663764

Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor

Hypofractionated Radiotherapy Combined With Concurrent Weekly Chemotherapy and Thymosin α1 in Patients With Unresectable or Recurrent Thymic Epithelial Tumor: A Prospective, Single-arm Phase II Study

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
57 (estimated)
Sponsor
Sun Yat-sen University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This phase II study was to assess the efficacy and toxicity of hypofractionated radiotherapy (HRT) combined with weekly docetaxel/platinum and thymosin α1 in patients with unresectable or recurrent thymic epithelia tumors (TETs).

Detailed description

HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used. All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy . Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.

Conditions

Interventions

TypeNameDescription
DRUGThymosin a1All patients received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
RADIATIONhypofractionated radiotherapyHRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.
DRUGconcurrent chemoradiotherapyAll patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .

Timeline

Start date
2018-08-13
Primary completion
2023-08-01
Completion
2023-08-01
First posted
2018-09-10
Last updated
2021-12-10

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03663764. Inclusion in this directory is not an endorsement.