Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

NCT02633514 | Withdrawn Phase 3 DMC

• 1 other identifier: 1508151-6
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate whether adjuvant radiochemotherapy after incomplete resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.

Conditions

Thymoma and Thymic Carcinoma

Keywords

thymoma; thymic carcinoma; adjuvant radiotherapy; adjuvant radiochemotherapy; incomplete resection

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  from registration to disease progression or death.

  2 years

Secondary Outcomes (2)

• Overall survival

  2 years

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

  2 years

Study Arms (2)

Radiochemotherapy

EXPERIMENTAL

adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)

Drug: Cisplatin; Drug: Etoposide; Radiation: radiotherapy

radiotherapy

SHAM COMPARATOR

adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX)

Radiation: radiotherapy

Interventions

Cisplatin DRUG

25mg/m2,iv gtt,d1-3

Also known as: DDP

Radiochemotherapy

Etoposide DRUG

75mg/m2,iv gtt,d1-3

Also known as: VP-16

Radiochemotherapy

radiotherapy RADIATION

60Gy/30Fx

Radiochemotherapy; radiotherapy

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; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed ; incomplete resection (R1 or R2);have adequate bone marrow, hepatic, and renal function;Patients receive incomplete resection within 3 months; Written informed consent.

You may not qualify if:

• Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have 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

Interventions

Cisplatin; Etoposide; Radiotherapy

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Therapeutics

Study Officials

• Kailiang Wu, MD. PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CN (1)