Endometrial CancerPhase 2NCT04527900
The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach
A Phase 2 study testing carboplatin and paclitaxel and pelvic IMPT (Intensity Modulated Proton Therapy) in people with Endometrial Cancer, run by University of Maryland, Baltimore at 4 sites in United States.
Trial summary
A phase 2 study with the primary objective of testing treatment compliance of Upfront Intensity Modulated Proton Beam Therapy (IMPT) and Concurrent Chemotherapy (UPPROACH) for Post-operative Treatment in Loco-regionally Advanced Endometrial Cancer is non-inferior to the historic compliance rate of the chemoradiation… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- carboplatin and paclitaxel and pelvic IMPT (Intensity Modulated Proton Therapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Feb 2021to 2 Jul 2024
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery must have included a hysterectomy. Bilateral salpingo-oophorectomy, pelvic lymph node sampling, para-aortic lymph node sampling, and omentectomy are optional
- Patients will be staged according to FIGO 2009 staging system. Eligibility is defined based on clinical-pathologic features.
- Patients with endometrioid endometrial cancer with the following:
- Stage IA grade 3 with extensive LVSI
- Stage IB grade 3
- Stage II
Show all 19Show fewer
- Stage III (A, B, and C)
- Stage IVA who are recommended adjuvant whole pelvic RT (+/- lower para-aortic up to renal hilum) and systemic chemotherapy.
- Patients with clear cell, serous papillary carcinoma, or carcinosarcoma with stages IA-III who are recommended adjuvant whole pelvic RT (+/- lower para-aortic up to renal hilum) and systemic chemotherapy.
- Patients with a GOG Performance Status of 0, 1, or 2
- Patients with adequate organ function, reflected by the following parameters:
- WBC ≥ 3000/mcl
- Absolute neutrophil count (ANC) ≥ 1000/mcl
- Platelet count ≥ 100,000/mcl
- SGOT, SGPT, and alkaline phosphatase ≤ 2.5 X upper limit of normal (ULN)
- Bilirubin ≤ 1.5 X ULN
- Creatinine ≤ institutional ULN (if serum creatinine > ULN, estimated GFR ≥ 45 ml/min)
- Patients who have signed an approved informed consent and authorization permitting release of personal health information
- Patients must be 18 years of age or older
Who cannot join
- Patients with leiomyosarcoma
- Patients with clinically significant pelvic or para-aortic nodal disease, on post-surgery CT scan, that was not dissected and would require higher boost dose
- Patients with recurrent endometrial cancer with gross nodal or vaginal disease requiring high dose radiotherapy, or history of prior chemotherapy
- Patients with a history of prior pelvic/abdominal RT or with history of prior cancer treatment that contraindicates this protocol therapy including history of prior chemotherapy for any other malignancy.
- Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy
- Patients with an estimated survival of less than three months
- Patients with FIGO 2009 Stage IVB endometrial cancer
- Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
UMMC
Baltimore, Maryland, 21201
Central Maryland Radiation Oncology
Columbia, Maryland, 21044
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
About this study
Official title: The "Upproach" Approach: A Phase 2 Study Of Upfront Intensity Modulated Proton Beam Therapy (Impt) And Concurrent Chemotherapy For Post-Operative Treatment In Loco-Regionally Advanced Endometrial Cancer
A phase 2 study with the primary objective of testing treatment compliance of Upfront Intensity Modulated Proton Beam Therapy (IMPT) and Concurrent Chemotherapy (UPPROACH) for Post-operative Treatment in Loco-regionally Advanced Endometrial Cancer is non-inferior to the historic compliance rate of the chemoradiation arm of GOG 258 study
Read the detailed description
While there is a consensus that both adjuvant ChT and RT benefit patients with respect to locoregional and distant control, the sequencing of these therapies varies between institutions. Common approaches include sequential treatment, with 4-6 cycles of ChT followed by RT, sandwich therapy with RT sandwiched between 3 cycles of ChT, or concurrent CRT. Small retrospective studies have shown a benefit with respect to PFS and OS in the sandwich approach, however this has not been replicated in larger studies.
In more recent years, proton beam therapy (PBT) has become an increasingly common modality for the treatment of uterine malignancies and is capable of even more precise dose distributions than photon-based RT due to intrinsic properties of these much heavier particles. Dosimetric/planning studies from other institutions confirm the significant reduction of dose to critical normal tissues like bladder, bowel, rectum, and bone marrow.
Preliminary data from the University of Maryland Medical Center has suggested that IMPT using pencil beam scanning is feasible in patients with endometrial cancer, with only 10% of patients developing grade 2 GI toxicity and no patients developing ≥ grade 3 GI or GU toxicities (abstract under review).
The investigators would like to test the hypothesis that in the postoperative setting, patients with advanced endometrial cancer will be able to complete a course of full dose ChT - carboplatin and paclitaxel - concurrent with upfront pelvic IMPT.
- Conditions
- Endometrial Cancer
- Being tested
- carboplatin and paclitaxel, pelvic IMPT (Intensity Modulated Proton Therapy)
- Keywords
- Endometrial cancer, Gynecologic cancers, Radiotherapy, Proton Therapy, Chemotherapy, Chemoradiation
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatin and paclitaxelDrug
carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist)
pelvic IMPT (Intensity Modulated Proton Therapy)Radiation
whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
| Study group | Role | What they receive |
|---|---|---|
| Concurrent chemoradiation | Experimental | Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) Receives: Drug: carboplatin and paclitaxel; Radiation: pelvic IMPT (Intensity Modulated Proton Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed Full 6 Cycles of Chemotherapy Concurrently With IMPT
This will be measured as proportion of patients completing full 6 cycles of chemotherapy concurrently with IMPT
Measured: End of study, approximately 4 years
Secondary outcomes (7)
Number of Participants With Acute GI and Urinary Toxicity
Measured by CTCAE (Common Terminology Criteria for Adverse Events). Toxicities noted did not meet the criteria for Serious Adverse Event. No SAEs noted.
Measured: once a week during radiation treatment, up to 5-6 weeks
Number of Participants With Acute GI and Urinary Toxicity Measured by PRO-CTCAE
Measured by PRO-CTCAE (Patient reported outcomes Common Terminology Criteria for Adverse Events)
Measured: once a week during radiation treatment, up to 5-6 weeks
Number of Participants With Acute GI and Urinary Toxicity Measured by EPIC
Measured by EPIC (Expanded Prostate Cancer Index Composite ) bowel and urinary domain
Measured: once a week during radiation treatment, up to 5-6 weeks
Number of Participants With Acute Hematologic Toxicity
Measured by CTCAE (Common Terminology Criteria for Adverse Events). Toxicities noted did not meet the criteria for Serious Adverse Event. No SAEs noted.
Measured: Prior to each cycle of chemotherapy (once every 21 days for 106 days)
Number of Participants With Late GI and Urinary Toxicity
Measured by CTCAE (Common Terminology Criteria for Adverse Events)
Measured: 6-month following radiation therapy
Number of Participants With Late GI and Urinary Toxicity Per PRO-CTCAE
Measured by PRO-CTCAE (Patient reported outcomes Common Terminology Criteria for Adverse Events)
Measured: 6-month following radiation therapy
Number of Participants With Late GI and Urinary Toxicity Measured by EPIC
Measured by EPIC (Expanded Prostate Cancer Index Composite ) bowel and urinary domain
Measured: 6-month following radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start23 Feb 2021
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Why it stopped: SOC changed and low enrollment
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 Endometrial 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Pranshu Mohindra, MD, Principal investigator, University of Maryland/Maryland Proton Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527900
- Sponsor's protocol ID
- HP-00092397
- Status last verified
- Jul 2026
- First submitted
- 14 Aug 2020
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Upproach" Approach: A Phase 2 Study Of Upfront Intensity Modulated Proton Beam Therapy (Impt) And Concurrent Chemotherapy For Post-Operative Treatment In Loco-Regionally Advanced Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04527900
- Acronym / sponsor ID
- HP-00092397
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer, Gynecologic cancers, Radiotherapy, Proton Therapy, Chemotherapy, Chemoradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: SOC changed and low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2 study with the primary objective of testing treatment compliance of Upfront Intensity Modulated Proton Beam Therapy (IMPT) and Concurrent Chemotherapy (UPPROACH) for Post-operative Treatment in Loco-regionally Advanced Endometrial Cancer is non-inferior to the historic compliance rate of the chemoradiation arm of GOG 258 study
Detailed description
While there is a consensus that both adjuvant ChT and RT benefit patients with respect to locoregional and distant control, the sequencing of these therapies varies between institutions. Common approaches include sequential treatment, with 4-6 cycles of ChT followed by RT, sandwich therapy with RT sandwiched between 3 cycles of ChT, or concurrent CRT. Small retrospective studies have shown a benefit with respect to PFS and OS in the sandwich approach, however this has not been replicated in larger studies.
In more recent years, proton beam therapy (PBT) has become an increasingly common modality for the treatment of uterine malignancies and is capable of even more precise dose distributions than photon-based RT due to intrinsic properties of these much heavier particles. Dosimetric/planning studies from other institutions confirm the significant reduction of dose to critical normal tissues like bladder, bowel, rectum, and bone marrow.
Preliminary data from the University of Maryland Medical Center has suggested that IMPT using pencil beam scanning is feasible in patients with endometrial cancer, with only 10% of patients developing grade 2 GI toxicity and no patients developing ≥ grade 3 GI or GU toxicities (abstract under review).
The investigators would like to test the hypothesis that in the postoperative setting, patients with advanced endometrial cancer will be able to complete a course of full dose ChT - carboplatin and paclitaxel - concurrent with upfront pelvic IMPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent chemoradiation | Experimental | Drug: carboplatin and paclitaxel, Radiation: pelvic IMPT (Intensity Modulated Proton Therapy)Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Surgery must have included a hysterectomy. Bilateral salpingo-oophorectomy, pelvic lymph node sampling, para-aortic lymph node sampling, and omentectomy are optional
- Patients will be staged according to FIGO 2009 staging system. Eligibility is defined based on clinical-pathologic features.
- Patients with endometrioid endometrial cancer with the following:
- Patients with clear cell, serous papillary carcinoma, or carcinosarcoma with stages IA-III who are recommended adjuvant whole pelvic RT (+/- lower para-aortic up to renal hilum) and systemic chemotherapy.
- Patients with a GOG Performance Status of 0, 1, or 2
Key exclusion criteria (8 listed)
- Patients with leiomyosarcoma
- Patients with clinically significant pelvic or para-aortic nodal disease, on post-surgery CT scan, that was not dissected and would require higher boost dose
- Patients with recurrent endometrial cancer with gross nodal or vaginal disease requiring high dose radiotherapy, or history of prior chemotherapy
- Patients with a history of prior pelvic/abdominal RT or with history of prior cancer treatment that contraindicates this protocol therapy including history of prior chemotherapy for any other malignancy.
- Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy
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 |
|---|---|---|
| carboplatin and paclitaxelcarboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist) | Drug | Concurrent chemoradiation |
| pelvic IMPT (Intensity Modulated Proton Therapy)whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions | Radiation | Concurrent chemoradiation |
Primary outcome
Number of Participants Who Completed Full 6 Cycles of Chemotherapy Concurrently With IMPT
Time frame: End of study, approximately 4 years
This will be measured as proportion of patients completing full 6 cycles of chemotherapy concurrently with IMPT
7 secondary outcomes
Number of Participants With Acute GI and Urinary Toxicity
Time frame: once a week during radiation treatment, up to 5-6 weeks
Number of Participants With Acute GI and Urinary Toxicity Measured by PRO-CTCAE
Time frame: once a week during radiation treatment, up to 5-6 weeks
Number of Participants With Acute GI and Urinary Toxicity Measured by EPIC
Time frame: once a week during radiation treatment, up to 5-6 weeks
Number of Participants With Acute Hematologic Toxicity
Time frame: Prior to each cycle of chemotherapy (once every 21 days for 106 days)
Number of Participants With Late GI and Urinary Toxicity
Time frame: 6-month following radiation therapy
Number of Participants With Late GI and Urinary Toxicity Per PRO-CTCAE
Time frame: 6-month following radiation therapy
Number of Participants With Late GI and Urinary Toxicity Measured by EPIC
Time frame: 6-month following radiation therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pranshu Mohindra, MD principal investigator
University of Maryland/Maryland Proton Treatment Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin and paclitaxel and pelvic IMPT (Intensity Modulated Proton Therapy) in people with Endometrial Cancer, run by University of Maryland, Baltimore at 4 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 19 inclusion and 8 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: stopped early, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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?
Yes. Results are posted in the registry (first posted 8 Jul 2026). 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 Participants Who Completed Full 6 Cycles of Chemotherapy Concurrently With IMPT (time frame: End of study, approximately 4 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 8 Jul 2026.