ThymomaPhase 2NCT00387868
Preoperative Treatment of Patients With High Risk Thymoma
A Phase 2 study testing cisplatin and etoposide, Surgical Resection and Concurrent Radiotherapy in people with Thymoma, run by Valley Health System at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thymoma
- What is being tested?
- cisplatin and etoposide, Surgical Resection and Concurrent Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2006to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Valley Health System - The Valley Hospital
Ridgewood, New Jersey, 07450
About this study
Official title: Phase II Study of Trimodality Therapy for Patients With Thymoma or Thymic Carcinoma at Significant Risk for Recurrence
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.
Read the detailed description
Past experience has suggested that the ability to completely remove the thymoma using surgery is important in preventing recurrence. Strategies which would help the surgeon's ability to completely remove the tumor therefore need to be investigated.
This study represents a multi-institutional, phase II pilot trial of preoperative chemoradiotherapy followed by surgical resection and postoperative chemotherapy for patients with invasive thymoma or thymic carcinoma at significant risk for recurrence. We hypothesize that this strategy will be well-tolerated and produce response and resectability rates exceeding those previously published involving surgical resection alone, or preoperative chemotherapy followed by surgery. Patients with locally advanced thymoma, based on radiographic and biopsy criteria, will undergo pretreatment computed tomography (CT) scan and positron emission tomography (PET) followed by concurrent (simultaneous) chemotherapy (cisplatin and etoposide) and radiation. After this therapy, patients will be reassessed using computed tomography (CT) and PET, and undergo surgical resection of their tumors. Following resection, patients will be either observed, or treated with postoperative chemotherapy, or chemotherapy and radiation. Correlative genomic, serologic and pathologic studies will also be performed.
- Conditions
- Thymoma
- Being tested
- cisplatin and etoposide, Surgical Resection, Concurrent Radiotherapy
- Keywords
- Thymoma, Thymic carcinoma, Preoperative chemotherapy and radiation, Response rate
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin and etoposideDrug
Cisplatin: 50mg/m2 - administered on days 1,8,29\&36 Etoposide: 50 mg/m2 - administered on days 1-5 \& 29-33
Surgical ResectionProcedure or surgery
Resection will take place 4-8 weeks after completion of radiotherapy.
Concurrent RadiotherapyRadiation
Preoperative External Beam Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Registration | Other | Cisplatin, Etoposide \& concurrent radiotherapy Receives: Drug: cisplatin and etoposide; Radiation: Concurrent Radiotherapy |
| Surgical Resection | Other | No distant Progression post Registration Arm Receives: 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. Receives: Drug: cisplatin and etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (7)
Radiographic response to preoperative chemoradiotherapy by comparing pre and post treatment CT scans.
Measured: 16 weeks
Rate of complete resection following preoperative chemoradiotherapy as determined by pathologic examination of the specimen(s).
Measured: 1-5 weeks
Toxicities throughout the study treatment.
Measured: 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
Measured: 10 years
Immunohistochemical assessment of relevant markers before and after chemoradiation (EGFR, p53,and Ki-67).
Measured: 10-12 years
Blood-based correlative studies: genetic polymorphisms (EGFR, DNA repair, inflammatory gene pathways) and serologic analysis (EGFR, VEGF, bFGF, pro-MMP2 levels)
Measured: 8-10 years
Recurrence rates and failure patterns following the treatment regimen.
Measured: 5-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThymomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Korst, MD, Principal investigator, Valley Health Systems/ The Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387868
- Sponsor's protocol ID
- VHS07.0006a
- Status last verified
- Dec 2014
- First submitted
- 11 Oct 2006
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24139613Wright 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.
PubMed 18222230
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Trimodality Therapy for Patients With Thymoma or Thymic Carcinoma at Significant Risk for Recurrence
- ClinicalTrials.gov ID
- NCT00387868
- Acronym / sponsor ID
- VHS07.0006a
- Conditions
- Thymoma
- Keywords
- Thymoma, Thymic carcinoma, Preoperative chemotherapy and radiation, Response rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Valley Health SystemUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Past experience has suggested that the ability to completely remove the thymoma using surgery is important in preventing recurrence. Strategies which would help the surgeon's ability to completely remove the tumor therefore need to be investigated.
This study represents a multi-institutional, phase II pilot trial of preoperative chemoradiotherapy followed by surgical resection and postoperative chemotherapy for patients with invasive thymoma or thymic carcinoma at significant risk for recurrence. We hypothesize that this strategy will be well-tolerated and produce response and resectability rates exceeding those previously published involving surgical resection alone, or preoperative chemotherapy followed by surgery. Patients with locally advanced thymoma, based on radiographic and biopsy criteria, will undergo pretreatment computed tomography (CT) scan and positron emission tomography (PET) followed by concurrent (simultaneous) chemotherapy (cisplatin and etoposide) and radiation. After this therapy, patients will be reassessed using computed tomography (CT) and PET, and undergo surgical resection of their tumors. Following resection, patients will be either observed, or treated with postoperative chemotherapy, or chemotherapy and radiation. Correlative genomic, serologic and pathologic studies will also be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Registration | Other | Drug: cisplatin and etoposide, Radiation: Concurrent RadiotherapyCisplatin, Etoposide \& concurrent radiotherapy |
| Surgical Resection | Other | Procedure: Surgical ResectionNo distant Progression post Registration Arm |
| Post Resection | Other | Drug: cisplatin and etoposideAssessment post surgical procedure to determine if at higher risk of recurrence or if complete resection could not be achieved. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin and etoposideCisplatin: 50mg/m2 - administered on days 1,8,29\&36 Etoposide: 50 mg/m2 - administered on days 1-5 \& 29-33 | Drug | Post Resection, Registration |
| Surgical ResectionResection will take place 4-8 weeks after completion of radiotherapy. | Procedure or surgery | Surgical Resection |
| Concurrent RadiotherapyPreoperative External Beam Radiotherapy | Radiation | Registration |
Primary outcome
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
Time frame: 16 weeks
7 secondary outcomes
Radiographic response to preoperative chemoradiotherapy by comparing pre and post treatment CT scans.
Time frame: 16 weeks
Rate of complete resection following preoperative chemoradiotherapy as determined by pathologic examination of the specimen(s).
Time frame: 1-5 weeks
Toxicities throughout the study treatment.
Time frame: 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
Time frame: 10 years
Immunohistochemical assessment of relevant markers before and after chemoradiation (EGFR, p53,and Ki-67).
Time frame: 10-12 years
Blood-based correlative studies: genetic polymorphisms (EGFR, DNA repair, inflammatory gene pathways) and serologic analysis (EGFR, VEGF, bFGF, pro-MMP2 levels)
Time frame: 8-10 years
Recurrence rates and failure patterns following the treatment regimen.
Time frame: 5-7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Derived from this study: PubMed 24139613Korst 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.
- Derived from this study: PubMed 18222230Wright 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Korst, MD principal investigator
Valley Health Systems/ The Valley Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin and etoposide, Surgical Resection and Concurrent Radiotherapy in people with Thymoma, run by Valley Health System at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00387868, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.