Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

NCT02636556 | Completed DMC

• 1 other identifier: 1508151-5
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Conditions

Thymoma and Thymic Carcinoma

Keywords

thymoma; thymic carcinoma; chemoradiotherapy; inoperable

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria

  3 months after treatment

Secondary Outcomes (3)

• Overall survival

  2 years

• Progression free survival

  2 years

• Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0

  up to 2 years

Study Arms (1)

chemoradiation

EXPERIMENTAL

concurrent chemoradiation.

Radiation: concurrent chemoradiation

Interventions

concurrent chemoradiation RADIATION

The patients receive chemotherapy concurrent with Radiotherapy. The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w\*4.

chemoradiation

Eligibility Criteria

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

You may qualify if:

• \~75 years old; 2.Eastern Cooperative Oncology Group performance status of 0 to 2; 3.Pathologically or cytologically confirmed untreated thymoma or thymic carcinoma; 4.Unresectable, limited adanced disease could be encompassed within a tolerable radiotherapy field; 5.Have adequate bone marrow, hepatic, and renal function; 6.Patients who cannot receive surgery resection; 7.Written informed consent.

You may not qualify if:

• Distant metastases could not be encompassed within a tolerable radiotherapy field;
• Underwent surgery, radiotherapy or chemotherapy before entering this study ;
• Have other malignancy history excluding carcinoma in situ of cervix in the previous five years;
• Active clinical pulmonary infection;
• Pregnant or nursing.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Kailiang Wu

Shanghai, Shanghai Municipality, 20032, China

Location

MeSH Terms

Conditions

Thymoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kailiang Wu, M.D.,Ph.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Intensity modulated radiotherapy with VP-16/Cisplatin

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 21, 2015
• Study Start: June 1, 2011
• Primary Completion: August 1, 2018
• Study Completion: February 1, 2020
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)