Proton Radiotherapy for Stage I, IIA, and IIB Seminoma

NCT01557790 | Completed Results DMC

• 1 other identifier: UPCC 17811
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Stage I, IIA and IIB Seminoma

Keywords

Adult male; 18 years or older; clinical diagnosis

Outcome Measures

Primary Outcomes (1)

• Number of Serious Adverse Events

  5 years

Study Arms (1)

Proton RT

EXPERIMENTAL

Subjects receive proton radiation for seminoma

Radiation: Proton Radiation Therapy

Interventions

Proton Radiation Therapy RADIATION

Proton RT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusettes General Hospital

Boston, Massachusetts, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Protons

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Results Point of Contact

• Title: Justin E. Bekelman, MD
• Organization: University of Pennsylvania

bekelman@xrt.upenn.edu

(215)662-7292

Study Officials

• Justin Bekelman, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

• Jason Efstathiou, MD, Ph.D.

  Massachusettes General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 20, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 13, 2020
• Results First Posted: November 21, 2019

Record last verified: 2020-04

Locations

US (2)