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A Phase II Study of Adjuvant Proton Radiation Therapy for the Treatment of Stage I, IIA and IIB Seminoma


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Stage I Seminoma

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Trial Information

A Phase II Study of Adjuvant Proton Radiation Therapy for the Treatment of Stage I, IIA and IIB Seminoma


This is a Phase II study using proton radiation therapy in addition to their standard care
in subjects who have Stage I 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.

Inclusion Criteria


Inclusion Criteria

- 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.

- Pre-orchiectomy alpha-fetoprotein within normal limits

- 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)

- Abdominal/pelvic CT scan;

- Brain MRI if clinically indicated

- Bone scan if clinically indicated

- 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

- 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

- Patient age: 18 years

- Patient ECOG performance status: 0-1 (Appendix C)

- Patients requiring concurrent noninvestigational medications will be permitted

- Adequate renal function, defined as follows: Serum creatinine <1.4 mg/dl or
creatinine clearance ≥60 ml/min within one month prior to registration

- Informed consent: Patients must have the ability to understand and be willing to sign
the study-specific informed consent indicating their understanding of the
investigational nature and the risks of this study before any of the protocol related
studies are preformed (this does not include routine laboratory testing or imaging
studies required to establish study eligibility)

Exclusion Criteria

- 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

- 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Number of Serious Adverse Events

Safety Issue:

Yes

Principal Investigator

Justin Bekelman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 17811

NCT ID:

NCT01557790

Start Date:

March 2012

Completion Date:

March 2017

Related Keywords:

  • Stage I Seminoma
  • Adult male
  • 18 years or older
  • clinical diagnosis
  • Seminoma

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Massachusettes General HospitalBoston, Massachusetts  02114