Stage I, IIA and IIB SeminomaNCT01557790
Proton Radiotherapy for Stage I, IIA, and IIB Seminoma
A study testing Proton Radiation Therapy in people with Stage I, IIA and IIB Seminoma, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
Trial summary
Phase II study using Proton radiation therapy to treat males, aged 18 years or older, with Stage I, IIA and IIB Seminoma. This research study will be done in conjunction with the Robert H. Burr Proton Therapy Center at the Mass. General Hospital and the Department of Defense. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stage I, IIA and IIB Seminoma
- What is being tested?
- Proton Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis; Histologically proven diagnosis of testicular seminoma; - Histologically confirmed seminomatous germ cell tumor of the testis categorized as either "classical" or "anaplastic;
- Stage I disease; Any pT N0 M0 S0-3 (Appendix B) [AJCC, 7th Ed.] (72); Stage IIA or IIB disease;
- Any pT N1 M0 S0-3 (Appendix B) [AJCC, 7th Ed.] (72); Any pT N2 M0 S0-3 (Appendix B) [AJCC, 7th Ed.] (72); (at the discretion of the principal investigators, bulky stage IIB may be excluded from the study, according to National Comprehensive Cancer Center Guidelines. 2. Laboratory evaluations; Semen analysis (patients will not be excluded if they do not wish to have an analysis or their insurance denies the claim) Follice-stimulating hormone (prior to the start of radiation) Luteinizing Hormone (Prior to the start of radiation) Lactate Dehydrogenase (Prior to the start of radiation) Human Chorionic Gonadotropic (Prior to the start of radiation) Complete blood count (Prior to the start of radiation) Testosterone (prior to the start of radiation) 3. Appropriate stage for protocol entry, as per protocol section 3.2.1, , based upon the following minimum diagnostic workup: History and physical examination, including a complete list of current medications; Chest x-ray (PA and lateral views) or CT Chest (within 3 months of study registration); Abdominal/pelvic CT scan or Abd/pelvic MRI(within 3 months of study registration); Brain MRI if clinically indicated; Bone scan if clinically indicated; 4. For stage I seminoma patients only, definitive surgical intervention within ten weeks prior to registration; Patients undergoing scrotal violations (scrotal orchiectomy, transscrotal biopsy, testicular fine needle aspiration, scrotal exploration) will be eligible; 5. The patient is a candidate for definitive external beam radiotherapy; The patient has had no prior radiotherapy to the region of study; The patient has no inflammatory bowel disease, active collagen vascular or connective tissue disorders, and no other medical or social contraindications to radiotherapy, as determined by a participating radiation oncologist; 6. Patient age: ³18 years; 7. Patient ECOG performance status: 0-1 (Appendix C); 8. For Stage II disease recurrence, rebiopsy is not clinically indicated. Imaging suffices for confirmation of recurrence
Who cannot join
- Prior radiotherapy to the region of the study cancer
- Prior radiation therapy for a different cancer or disease process is allowed, provided there will be no overlap of radiation therapy fields between the participant's prior and current course of radiation therapy, radiotherapy was completed more than four weeks from first fraction of proton therapy administered in this study, and the participant has recovered to Grade ≤1 toxicity related to prior radiotherapy
- Chemotherapy administered for the diagnosis of seminoma
- Prior chemotherapy for a different cancer is allowed, provided therapy was completed more than twelve months from first fraction of proton therapy administered in this study and the participant has recovered to Grade ≤1 toxicity related to agents previously administered
- Incomplete definitive surgical orchiectomy, including diagnostic biopsy alone
- Pelvic lymph node dissection for the diagnosis of seminoma
Show all 10Show fewer
- An investigational drug administered for the diagnosis of seminoma given concurrently or within four weeks of the first fraction of proton therapy administration
- Prior or concurrent second invasive malignancy other than non-melanoma skin cancer, unless disease free for a minimum of five years
- Known severe, active co-morbidity, defined as follows:Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patient's ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results
- Cognitively impaired patients who cannot provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusettes General Hospital
Boston, Massachusetts
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II Study of Adjuvant Proton Radiation Therapy for the Treatment of Stage I, IIA and IIB Seminoma
Phase II study using Proton radiation therapy to treat males, aged 18 years or older, with Stage I, IIA and IIB Seminoma. This research study will be done in conjunction with the Robert H. Burr Proton Therapy Center at the Mass. General Hospital and the Department of Defense. In the feasibility portion of the study patients will be evaluated to determine acute toxicity. If the study is deemed feasible the principal investigator (PI) hopes that proton RT will reduce the lethargy rate as compared to photon radiation therapy (RT).
Read the detailed description
This is a Phase II study using proton radiation therapy in addition to their standard care in subjects who have Stage I, IIA, IIB Seminoma. Testicular cancer are the most common solid cancers among men aged 20 to 35. Each subject must be 18 years of age or older and have a histologically proven diagnosis of testicular cancer. In addition to a subject's routine exams and tests, they will be asked to complete a series of quality of life questionnaires before, during and after their treatment. All side effects/toxicities will be monitored and recorded. Patients will be followed for a minimum of 5 years.
- Conditions
- Stage I, IIA and IIB Seminoma
- Being tested
- Proton Radiation Therapy
- Keywords
- Adult male, 18 years or older, clinical diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Radiation TherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Proton RT | Experimental | Subjects receive proton radiation for seminoma Receives: Radiation: Proton Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Serious Adverse Events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage I, IIA and IIB SeminomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Justin Bekelman, MD, Principal investigator, Abramson Cancer Center at Penn MedicineJason Efstathiou, MD, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557790
- Sponsor's protocol ID
- UPCC 17811
- Status last verified
- Apr 2020
- First submitted
- 16 Mar 2012
- Last updated
- 13 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Adjuvant Proton Radiation Therapy for the Treatment of Stage I, IIA and IIB Seminoma
- ClinicalTrials.gov ID
- NCT01557790
- Acronym / sponsor ID
- UPCC 17811
- Conditions
- Stage I, IIA and IIB Seminoma
- Keywords
- Adult male, 18 years or older, clinical diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Mar 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Posted 21 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II study using Proton radiation therapy to treat males, aged 18 years or older, with Stage I, IIA and IIB Seminoma. This research study will be done in conjunction with the Robert H. Burr Proton Therapy Center at the Mass. General Hospital and the Department of Defense. In the feasibility portion of the study patients will be evaluated to determine acute toxicity. If the study is deemed feasible the principal investigator (PI) hopes that proton RT will reduce the lethargy rate as compared to photon radiation therapy (RT).
Detailed description
This is a Phase II study using proton radiation therapy in addition to their standard care in subjects who have Stage I, IIA, IIB Seminoma. Testicular cancer are the most common solid cancers among men aged 20 to 35. Each subject must be 18 years of age or older and have a histologically proven diagnosis of testicular cancer. In addition to a subject's routine exams and tests, they will be asked to complete a series of quality of life questionnaires before, during and after their treatment. All side effects/toxicities will be monitored and recorded. Patients will be followed for a minimum of 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton RT | Experimental | Radiation: Proton Radiation TherapySubjects receive proton radiation for seminoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histological diagnosis; Histologically proven diagnosis of testicular seminoma; - Histologically confirmed seminomatous germ cell tumor of the testis categorized as either "classical" or "anaplastic;
- Stage I disease; Any pT N0 M0 S0-3 (Appendix B) [AJCC, 7th Ed.] (72); Stage IIA or IIB disease;
- Any pT N1 M0 S0-3 (Appendix B) [AJCC, 7th Ed.] (72); Any pT N2 M0 S0-3 (Appendix B) [AJCC, 7th Ed.] (72); (at the discretion of the principal investigators, bulky stage IIB may be excluded from the study, according to National Comprehensive Cancer Center Guidelines. 2. Laboratory evaluations; Semen analysis (patients will not be excluded if they do not wish to have an analysis or their insurance denies the claim) Follice-stimulating hormone (prior to the start of radiation) Luteinizing Hormone (Prior to the start of radiation) Lactate Dehydrogenase (Prior to the start of radiation) Human Chorionic Gonadotropic (Prior to the start of radiation) Complete blood count (Prior to the start of radiation) Testosterone (prior to the start of radiation) 3. Appropriate stage for protocol entry, as per protocol section 3.2.1, , based upon the following minimum diagnostic workup: History and physical examination, including a complete list of current medications; Chest x-ray (PA and lateral views) or CT Chest (within 3 months of study registration); Abdominal/pelvic CT scan or Abd/pelvic MRI(within 3 months of study registration); Brain MRI if clinically indicated; Bone scan if clinically indicated; 4. For stage I seminoma patients only, definitive surgical intervention within ten weeks prior to registration; Patients undergoing scrotal violations (scrotal orchiectomy, transscrotal biopsy, testicular fine needle aspiration, scrotal exploration) will be eligible; 5. The patient is a candidate for definitive external beam radiotherapy; The patient has had no prior radiotherapy to the region of study; The patient has no inflammatory bowel disease, active collagen vascular or connective tissue disorders, and no other medical or social contraindications to radiotherapy, as determined by a participating radiation oncologist; 6. Patient age: ³18 years; 7. Patient ECOG performance status: 0-1 (Appendix C); 8. For Stage II disease recurrence, rebiopsy is not clinically indicated. Imaging suffices for confirmation of recurrence
Key exclusion criteria (10 listed)
- Prior radiotherapy to the region of the study cancer
- Prior radiation therapy for a different cancer or disease process is allowed, provided there will be no overlap of radiation therapy fields between the participant's prior and current course of radiation therapy, radiotherapy was completed more than four weeks from first fraction of proton therapy administered in this study, and the participant has recovered to Grade ≤1 toxicity related to prior radiotherapy
- Chemotherapy administered for the diagnosis of seminoma
- Prior chemotherapy for a different cancer is allowed, provided therapy was completed more than twelve months from first fraction of proton therapy administered in this study and the participant has recovered to Grade ≤1 toxicity related to agents previously administered
- Incomplete definitive surgical orchiectomy, including diagnostic biopsy alone
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 |
|---|---|---|
| Proton Radiation Therapy | Radiation | Proton RT |
Primary outcome
Number of Serious Adverse Events
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Justin Bekelman, MD principal investigator
Abramson Cancer Center at Penn Medicine
Jason Efstathiou, MD, Ph.D. principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Radiation Therapy in people with Stage I, IIA and IIB Seminoma, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
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 3 inclusion and 10 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 13 Apr 2020. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Serious Adverse Events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2020.