Your session is about to expire
← Back to Search
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, approximately 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
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.
Select...
My kidney function, measured by creatinine levels, is normal or nearly normal.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study, approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study, approximately 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compliance rates
Secondary outcome measures
Acute GI and urinary toxicity
Acute hematologic toxicity
Late GI and urinary toxicity
Side effects data
From 2005 Phase 3 trial • 612 Patients • NCT0005096075%
Non-small cell lung cancer
57%
Hypotriglyceridemia
53%
Fatigue
50%
Nausea
50%
Anemia
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%
Myalgia
21%
Cough
19%
Pain in extremity
16%
Rash
16%
Pyrexia
15%
Thrombocytopenia
15%
Chest pain
15%
Dizziness
14%
Dehydration
14%
Weight decreased
13%
Abdominal pain
13%
Oedema peripheral
13%
Depression
13%
Headache
12%
Dermatitis exfoliative
12%
Back pain
12%
Hypercholesterolemia
11%
Leukopenia
11%
Anxiety
10%
Polyneuropathy
10%
Paraesthesia
9%
Neuropathy
9%
Pruritis
9%
Pain
9%
Hypomagnesemia
9%
Blood triglycerides increased
8%
Dry skin
8%
Confusional state
8%
Bone pain
8%
Hypokalaemia
7%
Dyspnoea exacerbated
7%
Epistaxis
7%
Dysphagia
6%
Abdominal pain upper
6%
Pharyngolaryngeal pain
6%
Hypotension
6%
Dyspepsia
6%
Febrile neutropenia
6%
Dysgeusia
6%
Stomatitis
6%
Haemoptysis
5%
Flushing
5%
Skin desquamation
5%
Hoarseness
5%
Anaemia
5%
Hyponatremia
5%
Hyperlipidemia
5%
Hyperglycaemia
3%
Pulmonary embolism
3%
Pleural effusion
3%
Respiratory failure
3%
Diarrhea
3%
Pneumonia
1%
Hypoxia
1%
Atrial fibrillation
1%
Pancytopenia
1%
Deep vein thrombosis
1%
Chronic obstructive airways disease exacerbated
1%
Hepatic failure
1%
Sepsis
1%
Convulsion
1%
Cerebrovascular accident
1%
Spinal cord compression
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
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
688 Previous Clinical Trials
374,635 Total Patients Enrolled
Pranshu Mohindra, MDPrincipal InvestigatorUniversity of Maryland/Maryland Proton Treatment Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I have recurrent endometrial cancer needing high dose radiotherapy or have had chemotherapy before.I am stage IVA and advised to get pelvic radiation and chemotherapy.I have significant nodal disease in my pelvis or para-aortic area that wasn't removed and needs a higher radiation dose.I have had a hysterectomy.My cancer is early stage but aggressive with lymph vessel invasion.My cancer is at stage III.I have not had radiation in the pelvic/abdominal area or chemotherapy that would interfere with this treatment.My cancer stage was determined using the FIGO 2009 system.You have been given a prognosis of less than three months to live.I haven't had a heart attack, unstable chest pain, or uncontrolled heart rhythm issues in the last 3 months.I have endometrioid endometrial cancer.My cancer is at an early stage but is aggressive.My cancer is in stages IA-III and recommended for specific radiation and chemotherapy.My condition is Stage IVB endometrial cancer according to FIGO 2009.I have been diagnosed with leiomyosarcoma.My organs are functioning well.My kidney function, measured by creatinine levels, is normal or nearly normal.My cancer is at stage II.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Concurrent chemoradiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What maladies might be addressed by a combination of carboplatin and paclitaxel?
"Carboplatin and paclitaxel is often prescribed to treat melanoma, as well as neoplasm metastasis, lymphomas of the non-Hodgkin variety, and advanced sarcomas."
Answered by AI
Are there any analogous experiments that have employed carboplatin and paclitaxel?
"Currently, 1174 clinical trials involving carboplatin and paclitaxel are in progress; of these, 332 have entered Phase 3. Most sites for this trial are located in Shanghai, but 66509 other locations globally also offer the same treatment."
Answered by AI
How many participants is this trial recruiting?
"Affirmative. Per the clinicaltrials.gov website, this medical investigation is presently seeking out 21 participants from 4 distinct healthcare facilities. The trial was originally published on February 23rd 2021 and last amended on April 26th 2022."
Answered by AI
Has recruitment for this research project begun?
"Affirmative. The clinical trial listing on the government website states that recruitment is currently underway, with an initial posting date of February 23rd 2021 and a most recent update being April 26th 2022. This medical experiment seeks to enrol 21 individuals in 4 separate locations."
Answered by AI
Has the FDA endorsed carboplatin and paclitaxel as viable treatments?
"Our team at Power has assigned a rating of 2 to carboplatin and paclitaxel, as this is still in the Phase 2 trial stage. This means there are some safety data present but efficacy has yet to be established."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger