NCT00387868

Brief Summary

This is a phase II study for patients with thymoma or thymic carcinoma thought to be at significant risk for recurrence following surgical removal. This study involves the use of combined chemotherapy and radiation therapy prior to surgery, in hopes of increasing the chances of complete resection. The chemoradiotherapy protocol is one which has been used extensively for other diseases, and the side effects are therefore well-documented. Patients with thymomas thought to be at significant risk for recurrence (by x-ray and pathology criteria) will be allowed to participate, and will undergo combined chemotherapy with radiation to the chest followed by surgical removal of the tumor and postoperative chemotherapy. The main outcome measured will be the rate of pathological complete response (e.g. no active tumor in the resected specimen) to the preoperative treatment. Patients will receive postoperative treatment based on surgical and pathologic criteria.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

8 years

First QC Date

October 11, 2006

Last Update Submit

December 8, 2014

Conditions

Thymoma

Keywords

ThymomaThymic carcinomaPreoperative chemotherapy and radiationResponse rate

Outcome Measures

Primary Outcomes (1)

  • To determine the complete pathologic response rate to peroperative cisplatin and etoposide given concurrently with radiation in patients with thymoma thought to be at high risk for recurrence

    16 weeks

Secondary Outcomes (7)

  • Radiographic response to preoperative chemoradiotherapy by comparing pre and post treatment CT scans.

    16 weeks

  • Rate of complete resection following preoperative chemoradiotherapy as determined by pathologic examination of the specimen(s).

    1-5 weeks

  • Toxicities throughout the study treatment.

    5 years

  • The role of PET in predicting resectability, Masaoka stage and histologic type, as well as the response to preoperative chemoradiotherapy by comparing pre and post treatment PET scans

    10 years

  • Immunohistochemical assessment of relevant markers before and after chemoradiation (EGFR, p53,and Ki-67).

    10-12 years

  • +2 more secondary outcomes

Study Arms (3)

Registration

OTHER

Cisplatin, Etoposide \& concurrent radiotherapy

Drug: cisplatin and etoposideRadiation: Concurrent Radiotherapy

Surgical Resection

OTHER

No distant Progression post Registration Arm

Procedure: Surgical Resection

Post Resection

OTHER

Assessment post surgical procedure to determine if at higher risk of recurrence or if complete resection could not be achieved.

Drug: cisplatin and etoposide

Interventions

cisplatin and etoposideDRUG

Cisplatin: 50mg/m2 - administered on days 1,8,29\&36 Etoposide: 50 mg/m2 - administered on days 1-5 \& 29-33

Post ResectionRegistration
Surgical ResectionPROCEDURE

Resection will take place 4-8 weeks after completion of radiotherapy.

Surgical Resection
Concurrent RadiotherapyRADIATION

Preoperative External Beam Radiotherapy

Registration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy-proven thymoma or thymic carcinoma.
  • Invasive thymoma determined by specific radiographic criteria determined by CT scan.
  • Acceptable kidney, liver, bone marrow, and respiratory functions.
  • Karnofsy performance status greater than 80%.
  • Patients must have a CT of the chest with IV contrast within 60 days of enrollment.
  • Tumors larger than 8cm in greatest diameter on CT scan.
  • For tumors 5-8cm in greatest diameter on CT scan, one or more of the following radiographic criteria must also be present on IV contrast CT Scan:
  • Multifocal calcification
  • Heterogeneous appearance
  • Irregular of scalloped borders
  • Obvious great vessel invasion or encirclement

You may not qualify if:

  • Considered unable to medically tolerate surgical resection at the time of initial presentation.
  • Radiographic evidence of stage IVA thymoma.
  • Pretreatment biopsy showing WHO type A thymoma unless obvious great vessel invasion/encirclement is present on CT scan.
  • Previous radiation therapy to the chest which would preclude the administration of radiation.
  • Patents receiving other investigational drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Valley Health System - The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

University of Toronto

Toronto, Ontario, M5G2C4, Canada

Location

Related Publications (2)

  • Korst RJ, Bezjak A, Blackmon S, Choi N, Fidias P, Liu G, Marx A, Wright C, Mock S, Rutledge JR, Keshavjee S. Neoadjuvant chemoradiotherapy for locally advanced thymic tumors: a phase II, multi-institutional clinical trial. J Thorac Cardiovasc Surg. 2014 Jan;147(1):36-44, 46.e1. doi: 10.1016/j.jtcvs.2013.08.061. Epub 2013 Oct 15.

    PMID: 24139613DERIVED

  • Wright CD, Choi NC, Wain JC, Mathisen DJ, Lynch TJ, Fidias P. Induction chemoradiotherapy followed by resection for locally advanced Masaoka stage III and IVA thymic tumors. Ann Thorac Surg. 2008 Feb;85(2):385-9. doi: 10.1016/j.athoracsur.2007.08.051.

    PMID: 18222230DERIVED

MeSH Terms

Conditions

Thymoma

Interventions

CisplatinEtoposide

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsThymus NeoplasmsThoracic NeoplasmsNeoplasms by SiteLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Robert Korst, MD

    Valley Health Systems/ The Valley Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2006

First Posted

October 13, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

CA(1)US(1)