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Chemotherapy

Chemotherapy + IMPT for Endometrial Cancer

Phase 2
Recruiting
Led By Pranshu Mohindra, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a GOG Performance Status of 0, 1, or 2
Stage IVA who are recommended adjuvant whole pelvic RT (+/- lower para-aortic up to renal hilum) and systemic chemotherapy.
Must not have
Patients with recurrent endometrial cancer with gross nodal or vaginal disease requiring high dose radiotherapy, or history of prior chemotherapy
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, approximately 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to give radiation and chemotherapy to women with endometrial cancer. They want to see if it is as good as the standard way of giving these treatments.

Who is the study for?
This trial is for adults with advanced endometrial cancer who've had a hysterectomy and possibly other related surgeries. It's open to those with certain stages of cancer, including stage IVA or IA-III if it's clear cell, serous papillary carcinoma, or carcinosarcoma. Participants need normal organ function and no history of heart issues in the past 3 months. They can't have had prior chemotherapy for any cancer.
What is being tested?
The UPPROACH study tests whether combining Intensity Modulated Proton Beam Therapy (IMPT) with chemotherapy (carboplatin and paclitaxel) after surgery is as good at keeping patients on treatment as previous methods were. This phase 2 trial focuses on compliance rates compared to historical data from the GOG 258 study.
What are the potential side effects?
Possible side effects include reactions to carboplatin and paclitaxel such as nausea, hair loss, numbness in fingers or toes; IMPT may cause skin irritation or fatigue. Organ function will be monitored due to potential impact from both treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I am stage IVA and advised to get pelvic radiation and chemotherapy.
Select...
I have had a hysterectomy.
Select...
My cancer is early stage but aggressive with lymph vessel invasion.
Select...
My cancer is at an early stage but is aggressive.
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My kidney function, measured by creatinine levels, is normal or nearly normal.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have recurrent endometrial cancer needing high dose radiotherapy or have had chemotherapy before.
Select...
I have significant nodal disease in my pelvis or para-aortic area that wasn't removed and needs a higher radiation dose.
Select...
I have not had radiation in the pelvic/abdominal area or chemotherapy that would interfere with this treatment.
Select...
My condition is Stage IVB endometrial cancer according to FIGO 2009.
Select...
I have been diagnosed with leiomyosarcoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study, approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compliance rates
Secondary study objectives
Acute GI and urinary toxicity
Acute hematologic toxicity
Late GI and urinary toxicity

Side effects data

From 2005 Phase 3 trial • 612 Patients • NCT00050960
75%
Non-small cell lung cancer
57%
Hypotriglyceridemia
53%
Fatigue
50%
Anemia
50%
Nausea
50%
Alopecia
47%
Neutropenia
37%
Diarrhoea
33%
Vomiting
27%
Constipation
27%
Arthralgia
25%
Dyspnoea
25%
Hypothyroidism
24%
Anorexia
24%
Insomnia
24%
Neuropathy peripheral
23%
Asthenia
21%
Cough
21%
Myalgia
19%
Pain in extremity
16%
Rash
16%
Pyrexia
15%
Thrombocytopenia
15%
Dizziness
15%
Chest pain
14%
Weight decreased
14%
Dehydration
13%
Depression
13%
Headache
13%
Abdominal pain
13%
Oedema peripheral
12%
Hypercholesterolemia
12%
Dermatitis exfoliative
12%
Back pain
11%
Leukopenia
11%
Anxiety
10%
Paraesthesia
10%
Polyneuropathy
9%
Hypomagnesemia
9%
Neuropathy
9%
Pruritis
9%
Pain
9%
Blood triglycerides increased
8%
Hypokalaemia
8%
Confusional state
8%
Dry skin
8%
Bone pain
7%
Dyspnoea exacerbated
7%
Epistaxis
7%
Dysphagia
6%
Febrile neutropenia
6%
Dysgeusia
6%
Haemoptysis
6%
Pharyngolaryngeal pain
6%
Hypotension
6%
Dyspepsia
6%
Stomatitis
6%
Abdominal pain upper
5%
Flushing
5%
Anaemia
5%
Hyperglycaemia
5%
Hyponatremia
5%
Hyperlipidemia
5%
Hoarseness
5%
Skin desquamation
3%
Pulmonary embolism
3%
Pleural effusion
3%
Respiratory failure
3%
Diarrhea
3%
Pneumonia
1%
Hypoxia
1%
Atrial fibrillation
1%
Hepatic failure
1%
Chronic obstructive airways disease exacerbated
1%
Pancytopenia
1%
Sepsis
1%
Convulsion
1%
Cerebrovascular accident
1%
Spinal cord compression
1%
Deep vein thrombosis
1%
Non-small cell lung cancer Stage IV
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bexarotene With Carboplatin and Paclitaxel
Carboplatin and Paclitaxel

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Concurrent chemoradiationExperimental Treatment2 Interventions
Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
carboplatin and paclitaxel
2002
Completed Phase 3
~620

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,614 Total Patients Enrolled
Pranshu Mohindra, MDPrincipal InvestigatorUniversity of Maryland/Maryland Proton Treatment Center

Media Library

Carboplatin and Paclitaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04527900 — Phase 2
Endometrial Cancer Research Study Groups: Concurrent chemoradiation
Endometrial Cancer Clinical Trial 2023: Carboplatin and Paclitaxel Highlights & Side Effects. Trial Name: NCT04527900 — Phase 2
Carboplatin and Paclitaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04527900 — Phase 2
~9 spots leftby Sep 2027
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