CNS CancerReRTNCT05313191
Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors
A study testing Pencil Beam Scanning Proton Therapy in people with CNS Cancer and Head and Neck Cancer, run by The New York Proton Center at 1 site in United States.
Trial summary
The goal of this clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Cancer, Head and Neck Cancer, GI Cancer
- What is being tested?
- Pencil Beam Scanning Proton Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years
- Patient provides study specific informed consent prior to study entry.
- Documented history and physical exam within 90 days prior to registration.
- ECOG PS 0, 1, or 2 within 90 days prior to registration
Who cannot join
- Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up.
- Prior invasive non study malignancy unless disease free for ≥ 3 years
- Non melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.
- History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The New York Proton Center
New York, New York, 10035
Isabelle Choi, MD, 646-968-9060, research@nyproton.com
About this study
The goal of this clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. In some cases, the cancer either returns or a new tumor can present in a different part of the body. With the usual radiation treatment, the photon beams travel all the way through the body. As a result, healthy tissues in front of and behind the tumor are exposed to radiation. Physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. This dose is often not strong enough to destroy the cancerous tumor. Alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. Proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor.
The reason we are conducting this research study is to look at whether Proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date.
- Conditions
- CNS Cancer, Head and Neck Cancer, GI Cancer, Gynecologic Cancer, Prostate Cancer, Thoracic Cancer
- Being tested
- Pencil Beam Scanning Proton Therapy
- Keywords
- Reirradiation, Cancer, Proton Therapy, Radiation Therapy
- Medical subject headings
- Central Nervous System Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms, Prostatic Neoplasms, Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pencil Beam Scanning Proton TherapyRadiation
Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Central Nervous System | Experimental | Group 1 Definitive Reirradiation Phase II
* Patients w/history of intracranial or spinal (extradural, intradural, and/or intramedullary) CNS tumors for which radiation therapy was prev. delivered either to gross disease or in the postoperative setting
* Min. 6 month interval b/w RT courses
* Overlap of prior RT field (50% IDL)
* Subgroup analysis: receipt of surgery for recurrence/second IC tumor; concurrent ST; tumor histology
Group 2 CNS Reirradiation Registry
* Patients for whom a repeat course of RT to the CNS is indicated for recurrent disease or secondary primary
* Postop or intact setting
* Min. 6 month interval b/w RT courses
* Overlap of prior RT field (50% IDL)
* Histologically/clinically documented recurrent CNS tumor (benign or malignant)
* Glioblastoma (histologic or molecular including IDH wildtype)
* Astrocytoma (molecular IDH1 mutant)
* Oligodendroglioma (molecular 1p19q co deleted)
* Meningioma
* Ependymoma
* Chordoma/chondrosarcoma Receives: Radiation: Pencil Beam Scanning Proton Therapy |
| Cohort 2: Head/Neck | Experimental | Group 1 Full Dose Reirradiation Phase II
* Patients w/history of HNC for which RT was delivered definitively, now with recurrence to h/n amenable to full dose reRT
* Gross unresected disease or PORT 2/2 RF
* Received at least 40 Gy overlapping w/new target region
* Min. 6 month interval b/w RT courses
* Overlap of prior RT field (50% IDL)
* Subgroup analysis: surgery, HPV status, concurrent ST
Group 2 Early (<6months for prior RT) Palliative H/N ReRT Phase I
* Patients w/history of HNC for which RT was delivered definitively/adjuvant setting, now with biopsy proven recurrence to h/n with indication for palliative RT
* At least 30 Gy prior RT overlapping with new treatment volume
* <6 month interval between RT courses
Group 3 Head/Neck ReRT Registry
* Patients w/history of HNC for which RT was delivered now with recurrence/secondary primary requiring reRT
* Postop or definitive
* Prior RT dose at least 30 Gy overlapping w/new treatment volume
* Min.6 month interval b/w RT courses Receives: Radiation: Pencil Beam Scanning Proton Therapy |
| Cohort 3: Breast | Experimental | Group 1 Partial Breast Reirradiation (Phase II)
* Patients with a history of breast cancer s/p BCT, now with small (≤3cm), unicentric, ipsilateral breast cancer recurrence receiving repeat BCT
* Node negative
* Negative margins
* No LVI
* Lumpectomy cavity:whole breast <30%
* Minimum 1 year interval between RT courses
Group 2: Regional LN and Breast/CW ReRT (Phase II)
* Patients with a history of breast cancer s/p RT , now with recurrence or new primary with indication for reirradiation to the breast/chest wall and regional LN
* Minimum 1 year interval between RT courses
* Negative metastatic workup (PET/CT or CT C/A/P + bone scan)
* Excludes concurrent chemotherapy
Group 3: Breast Reirradiation Registry
* Patients with a history of breast cancer s/p RT , now with recurrence or new primary breast cancer with indication for reirradiation
* Some overlaps of dose with prior RT course
* Negative metastatic workup (PET/CT or CT C/A/P + bone scan)
* Excludes concurrent chemotherapy Receives: Radiation: Pencil Beam Scanning Proton Therapy |
| Cohort 4: Thoracic | Experimental | Group 1: Definitive Reirradiation for Locally Advanced Disease
* Single arm, prospective, phase II study
* Patients with a history of lung cancer s/p definitive RT , now with local recurrence of new primary centrally located and w/I 50% IDL of prior RT field
* Definitive reRT concurrent systemic therapy
* Adequate pulmonary function defined as an FEV1 of >35% (with or without bronchodilator) within 90 days prior to registration
* Minimum 6 month interval between RT courses
* Negative metastatic workup
Group 2: Thoracic Registry Study
* Registry design
* Patients with histologically confirmed thoracic malignancy (NSCLC, SCLC , mesothelioma, thymoma, carcinoid, intrathoracic sarcoma) with prior thoracic RT
* Minimum 3 month interval between RT courses
* Negative metastatic workup Receives: Radiation: Pencil Beam Scanning Proton Therapy |
| Cohort 5: Gastrointestinal | Experimental | Group 1 Esophagus \& GEJ Reirradiation Phase II
* Patients w/history of E/GEJ cancer s/p RT, now w/recurrent/new primary nonmetastatic E/GEJ cancer for which salvage RT is recommended
* Negative metastatic workup
Group 2 Liver Reirradiation Phase II
* Patients w/history of HCC, cholangiocarcinoma or liver mets (any histology), s/p prior EBRT, now with in field recurrence/new primary/met, for which definitive reRT is recommended
* CTP A or B7
* Excl. prev. Y 90/radioembolization
* Allow prior TACE
* Overlap w/50% IDL prior RT
* Adequate bone marrow function
Group 3 Lower GI Reirradiation Phase II
* Patients w/history of rectal/anal cancer s/p RT now w/recurrent/new primary nonmetastatic rectal/anal cancer for whom salvage RT is recommended +/ chemotherapy
* Negative metastatic workup (PET/CT or CT C/A/P)
Group 4 GI Reirradiation Registry
•Patients w/histologically document recurrent or new GI malignancy with prior history of RT w/overlap of current RT volume by the 50% IDL Receives: Radiation: Pencil Beam Scanning Proton Therapy |
| Cohort 6: Genitourinary | Experimental | Group 1 Locally recurrent prostate cancer w/in prev. radiation field Phase II
* Patients w/recurrent prostate adenocarcinoma w/in prev. irradiated field w/indication for repeat course of radiation
* Min. 1 year interval b/w RT courses
* Prostate gland or recurrent tumor <100 cc or 6 cm in largest dimension
* No persistent grade 2+ toxicity from prior radiation
* Negative metastatic workup (bone scan, CT scan or PSMA/axumin scan
Group 2 Regional prostate cancer recurrence adjacent to the previous field Phase II
* Patients w/recurrent prostate adenocarcinoma beyond prior RT field (outside 50% IDL) but w/in pelvis)
* Min.1 year interval b/w RT courses (EBRT or brachy)
* No persistent grade 2+ toxicity from prior radiation
Group 3 Prostate Reirradiation Registry
* Patients w/recurrent prostate adenocarcinoma (prostate gland, postop bed, or pelvi c LN) who require RT to the prostate or pelvis in the setting of prior pelvis RT
* No DM
* Concurrent chemotherapy excl. Receives: Radiation: Pencil Beam Scanning Proton Therapy |
| Cohort 7: Gynecological | Experimental | Group 1: Locally recurrent gynecological cancer within previous field
* Single arm, prospective, phase II study design
* Patients with history of gyn cancer for which definitive or adjuvant/salvage PORT was given, now with recurrence within 50% IDL recommended for radiotherapy
* At least 1 year between RT courses
* No persistent grade 3+ toxicity from prior RT
* Concurrent chemotherapy excluded
* Uncontrolled or widely metastatic disease
* Life expectancy >6 months Receives: Radiation: Pencil Beam Scanning Proton Therapy |
| Cohort 8: Registry | No intervention | * Registry design * Any cancer patient for whom RT is indicated in the setting of prior RT and do not meet eligibility criteria for other cohorts * Overlap of 50% IDL of current treatment volume with prior RT field |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the cumulative rate of CTCAE v5.0 Grade ≥3 acute and late treatment related adverse events within 1 year of definitive reirradiation completion using proton therapy for recurrent or second primary tumor.
Measured: 5 years
Secondary outcomes (8)
To determine the 1 year freedom from local failure.
Measured: 1 year
To determine the 1 year freedom from progression free survival.
Measured: 1 year
To determine the 1 year freedom from overall survival.
Measured: 1 year
To determine the acute cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 90 days of reirradiation completion.
Measured: 90 days
To determine the late cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 2 years of reirradiation completion.
Measured: 2 years
To characterize patient reported outcomes within 1 year of reirradiation using the MDASI BT forms for intracranial tumors.
Measured: 1 years
To characterize patient reported outcomes within 1 year of reirradiation using the CTB COMP forms for intracranial tumors.
Measured: 1 years
To characterize patient reported outcomes within 1 year of reirradiation using the MDASI SP form for spinal tumors.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start24 Jan 2022
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Phase: Registry, Phase I, Phase II Study Design/Methodology: Cohort-defined, single arm prospective study
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The New York Proton Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313191
- Sponsor's protocol ID
- NYPC ERC# 2019-002
- Acronym
- ReRT
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors
- ClinicalTrials.gov ID
- NCT05313191
- Acronym / sponsor ID
- ReRT / NYPC ERC# 2019-002
- Conditions
- CNS Cancer, Head and Neck Cancer, GI Cancer, Gynecologic Cancer, Prostate Cancer, Thoracic Cancer
- Keywords
- Reirradiation, Cancer, Proton Therapy, Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- The New York Proton CenterUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 Apr 2022 (actual)
- 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.
The goal of this clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. In some cases, the cancer either returns or a new tumor can present in a different part of the body. With the usual radiation treatment, the photon beams travel all the way through the body. As a result, healthy tissues in front of and behind the tumor are exposed to radiation. Physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. This dose is often not strong enough to destroy the cancerous tumor. Alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. Proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor.
The reason we are conducting this research study is to look at whether Proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Phase: Registry, Phase I, Phase II Study Design/Methodology: Cohort-defined, single arm prospective study
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Central Nervous System | Experimental | Radiation: Pencil Beam Scanning Proton TherapyGroup 1 Definitive Reirradiation Phase II * Patients w/history of intracranial or spinal (extradural, intradural, and/or intramedullary) CNS tumors for which radiation therapy was prev. delivered either to gross disease or in the postoperative setting * Min. 6 month interval b/w RT courses * Overlap of prior RT field (50% IDL) * Subgroup analysis: receipt of surgery for recurrence/second IC tumor; concurrent ST; tumor histology Group 2 CNS Reirradiation Registry * Patients for whom a repeat course of RT to the CNS is indicated for recurrent disease or secondary primary * Postop or intact setting * Min. 6 month interval b/w RT courses * Overlap of prior RT field (50% IDL) * Histologically/clinically documented recurrent CNS tumor (benign or malignant) * Glioblastoma (histologic or molecular including IDH wildtype) * Astrocytoma (molecular IDH1 mutant) * Oligodendroglioma (molecular 1p19q co deleted) * Meningioma * Ependymoma * Chordoma/chondrosarcoma |
| Cohort 2: Head/Neck | Experimental | Radiation: Pencil Beam Scanning Proton TherapyGroup 1 Full Dose Reirradiation Phase II * Patients w/history of HNC for which RT was delivered definitively, now with recurrence to h/n amenable to full dose reRT * Gross unresected disease or PORT 2/2 RF * Received at least 40 Gy overlapping w/new target region * Min. 6 month interval b/w RT courses * Overlap of prior RT field (50% IDL) * Subgroup analysis: surgery, HPV status, concurrent ST Group 2 Early (<6months for prior RT) Palliative H/N ReRT Phase I * Patients w/history of HNC for which RT was delivered definitively/adjuvant setting, now with biopsy proven recurrence to h/n with indication for palliative RT * At least 30 Gy prior RT overlapping with new treatment volume * <6 month interval between RT courses Group 3 Head/Neck ReRT Registry * Patients w/history of HNC for which RT was delivered now with recurrence/secondary primary requiring reRT * Postop or definitive * Prior RT dose at least 30 Gy overlapping w/new treatment volume * Min.6 month interval b/w RT courses |
| Cohort 3: Breast | Experimental | Radiation: Pencil Beam Scanning Proton TherapyGroup 1 Partial Breast Reirradiation (Phase II) * Patients with a history of breast cancer s/p BCT, now with small (≤3cm), unicentric, ipsilateral breast cancer recurrence receiving repeat BCT * Node negative * Negative margins * No LVI * Lumpectomy cavity:whole breast <30% * Minimum 1 year interval between RT courses Group 2: Regional LN and Breast/CW ReRT (Phase II) * Patients with a history of breast cancer s/p RT , now with recurrence or new primary with indication for reirradiation to the breast/chest wall and regional LN * Minimum 1 year interval between RT courses * Negative metastatic workup (PET/CT or CT C/A/P + bone scan) * Excludes concurrent chemotherapy Group 3: Breast Reirradiation Registry * Patients with a history of breast cancer s/p RT , now with recurrence or new primary breast cancer with indication for reirradiation * Some overlaps of dose with prior RT course * Negative metastatic workup (PET/CT or CT C/A/P + bone scan) * Excludes concurrent chemotherapy |
| Cohort 4: Thoracic | Experimental | Radiation: Pencil Beam Scanning Proton TherapyGroup 1: Definitive Reirradiation for Locally Advanced Disease * Single arm, prospective, phase II study * Patients with a history of lung cancer s/p definitive RT , now with local recurrence of new primary centrally located and w/I 50% IDL of prior RT field * Definitive reRT concurrent systemic therapy * Adequate pulmonary function defined as an FEV1 of >35% (with or without bronchodilator) within 90 days prior to registration * Minimum 6 month interval between RT courses * Negative metastatic workup Group 2: Thoracic Registry Study * Registry design * Patients with histologically confirmed thoracic malignancy (NSCLC, SCLC , mesothelioma, thymoma, carcinoid, intrathoracic sarcoma) with prior thoracic RT * Minimum 3 month interval between RT courses * Negative metastatic workup |
| Cohort 5: Gastrointestinal | Experimental | Radiation: Pencil Beam Scanning Proton TherapyGroup 1 Esophagus \& GEJ Reirradiation Phase II * Patients w/history of E/GEJ cancer s/p RT, now w/recurrent/new primary nonmetastatic E/GEJ cancer for which salvage RT is recommended * Negative metastatic workup Group 2 Liver Reirradiation Phase II * Patients w/history of HCC, cholangiocarcinoma or liver mets (any histology), s/p prior EBRT, now with in field recurrence/new primary/met, for which definitive reRT is recommended * CTP A or B7 * Excl. prev. Y 90/radioembolization * Allow prior TACE * Overlap w/50% IDL prior RT * Adequate bone marrow function Group 3 Lower GI Reirradiation Phase II * Patients w/history of rectal/anal cancer s/p RT now w/recurrent/new primary nonmetastatic rectal/anal cancer for whom salvage RT is recommended +/ chemotherapy * Negative metastatic workup (PET/CT or CT C/A/P) Group 4 GI Reirradiation Registry •Patients w/histologically document recurrent or new GI malignancy with prior history of RT w/overlap of current RT volume by the 50% IDL |
| Cohort 6: Genitourinary | Experimental | Radiation: Pencil Beam Scanning Proton TherapyGroup 1 Locally recurrent prostate cancer w/in prev. radiation field Phase II * Patients w/recurrent prostate adenocarcinoma w/in prev. irradiated field w/indication for repeat course of radiation * Min. 1 year interval b/w RT courses * Prostate gland or recurrent tumor <100 cc or 6 cm in largest dimension * No persistent grade 2+ toxicity from prior radiation * Negative metastatic workup (bone scan, CT scan or PSMA/axumin scan Group 2 Regional prostate cancer recurrence adjacent to the previous field Phase II * Patients w/recurrent prostate adenocarcinoma beyond prior RT field (outside 50% IDL) but w/in pelvis) * Min.1 year interval b/w RT courses (EBRT or brachy) * No persistent grade 2+ toxicity from prior radiation Group 3 Prostate Reirradiation Registry * Patients w/recurrent prostate adenocarcinoma (prostate gland, postop bed, or pelvi c LN) who require RT to the prostate or pelvis in the setting of prior pelvis RT * No DM * Concurrent chemotherapy excl. |
| Cohort 7: Gynecological | Experimental | Radiation: Pencil Beam Scanning Proton TherapyGroup 1: Locally recurrent gynecological cancer within previous field * Single arm, prospective, phase II study design * Patients with history of gyn cancer for which definitive or adjuvant/salvage PORT was given, now with recurrence within 50% IDL recommended for radiotherapy * At least 1 year between RT courses * No persistent grade 3+ toxicity from prior RT * Concurrent chemotherapy excluded * Uncontrolled or widely metastatic disease * Life expectancy >6 months |
| Cohort 8: Registry | No intervention | –* Registry design * Any cancer patient for whom RT is indicated in the setting of prior RT and do not meet eligibility criteria for other cohorts * Overlap of 50% IDL of current treatment volume with prior RT field |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years
- Patient provides study specific informed consent prior to study entry.
- Documented history and physical exam within 90 days prior to registration.
- ECOG PS 0, 1, or 2 within 90 days prior to registration
Key exclusion criteria (4 listed)
- Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up.
- Prior invasive non study malignancy unless disease free for ≥ 3 years
- History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
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 |
|---|---|---|
| Pencil Beam Scanning Proton TherapyUse of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies | Radiation | Cohort 1: Central Nervous System, Cohort 2: Head/Neck, Cohort 3: Breast, Cohort 4: Thoracic, Cohort 5: Gastrointestinal, Cohort 6: Genitourinary, Cohort 7: Gynecological |
Primary outcome
To determine the cumulative rate of CTCAE v5.0 Grade ≥3 acute and late treatment related adverse events within 1 year of definitive reirradiation completion using proton therapy for recurrent or second primary tumor.
Time frame: 5 years
8 secondary outcomes
To determine the 1 year freedom from local failure.
Time frame: 1 year
To determine the 1 year freedom from progression free survival.
Time frame: 1 year
To determine the 1 year freedom from overall survival.
Time frame: 1 year
To determine the acute cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 90 days of reirradiation completion.
Time frame: 90 days
To determine the late cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 2 years of reirradiation completion.
Time frame: 2 years
To characterize patient reported outcomes within 1 year of reirradiation using the MDASI BT forms for intracranial tumors.
Time frame: 1 years
To characterize patient reported outcomes within 1 year of reirradiation using the CTB COMP forms for intracranial tumors.
Time frame: 1 years
To characterize patient reported outcomes within 1 year of reirradiation using the MDASI SP form for spinal tumors.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pencil Beam Scanning Proton Therapy in people with CNS Cancer and Head and Neck Cancer, run by The New York Proton Center at 1 site 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Holder, BS (646-968-9055 ext. 387, research@nyproton.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the cumulative rate of CTCAE v5.0 Grade ≥3 acute and late treatment related adverse events within 1 year of definitive reirradiation completion using proton therapy for recurrent or second primary tumor. (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 2026.