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Platinum-based Chemotherapy
Surgery + Chemotherapy + IMRT for Mesothelioma
Phase 2
Waitlist Available
Led By Andreas Rimner, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient age ≥ 18 years but ≤ 80 years at the time of consent
For patients enrolled post-P/D, only: FEV1 >/= 35% (corrected for Hgb) (Note: patients enrolled prior to P/D will have PFTs repeated pre-IMRT. If this criteria is not met, they will be removed from study)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new, safer radiation therapy for people with a certain type of lung cancer. The old radiation therapy had lots of side effects, but the new one specifically targets the cancer and reduces the risk of damaging healthy tissue.
Who is the study for?
This trial is for adults aged 18-80 with stage I-III malignant pleural mesothelioma, specifically epithelioid or biphasic subtypes. Participants must have good physical function and adequate organ function as shown by specific blood tests. Pregnant women, those with active infections requiring treatment, other cancers, serious illnesses, continuous oxygen use, or prior treatments like intrapleural therapy are excluded.Check my eligibility
What is being tested?
The study investigates the safety and effectiveness of combining surgery (pleurectomy/decortication), standard chemotherapy (pemetrexed with cisplatin or carboplatin), followed by a targeted radiation technique called IMRT that aims to minimize lung damage in patients with malignant pleural mesothelioma.See study design
What are the potential side effects?
Potential side effects include risks from surgery such as infection and bleeding; chemotherapy-related issues like nausea, fatigue, kidney problems; and radiation-induced pneumonitis. However, IMRT is designed to reduce many of the severe side effects associated with traditional radiation therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
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My lung function test shows at least 35% efficiency.
Select...
I am mostly self-sufficient and active.
Select...
My cancer has not spread to other parts of my body.
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My diagnosis of stage I-III malignant pleural mesothelioma is confirmed by a pathology report.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of patients ≥ grade 3 pneumonitis
Side effects data
From 2021 Phase 2 trial • 72 Patients • NCT0306761090%
dysgeusia
90%
Odynophagia
89%
Radiation dermatitis
88%
Dysphagia
85%
Weight loss
83%
dry mouth
81%
Fatigue
78%
Oral pain
76%
constipation
72%
Sore throat
71%
Lymphocyte count decreased
69%
Nausea
68%
Thick secretions
63%
anemia
60%
Oral mucositis
58%
Hypertension
54%
Neck pain
51%
Thrush
50%
White blood cell count decreased
43%
Platelet count decreased
43%
Productive cough
42%
Lymphadema
40%
Insomnia
38%
Dehydration
36%
Hyponatremia
36%
Mucositis
36%
Vomiting
35%
Anorexia
33%
cough
33%
Diarrhea
32%
Hypochloride
32%
Localized edema
31%
Hyperglycemia
31%
Nasal congestion
29%
dizziness
29%
erythema
29%
Hoarseness
28%
anxiety
28%
Tinnitus
25%
abdominal pain
25%
Headache
24%
Hypokalemia
24%
ear pain
24%
Generalized weakness
22%
Neutrophil count decreased
21%
back pain
21%
Hypomagnesemia
21%
creatinine increased
21%
depression
19%
dysphagia
19%
Rash
19%
Voice alteration
18%
Hypoalbuminemia
18%
Edema
18%
Hearing loss
17%
Fever
17%
Hypotension
17%
Hyperkalemia
17%
Throat pain
17%
Urinary frequency
15%
Acid Reflex
15%
Snoring
15%
ALT increased
15%
blurred vision
15%
Fall
15%
Joint pain
15%
Myalgias
14%
Hypocalcemia
14%
elevated creatinine
14%
Surgical Procedure - other
13%
Shoulder pain
13%
diaphoresis
11%
Seasonal allergies
11%
Cold Intolerance
11%
Hypercalcemia
11%
Laryngeal Edema
11%
Loss of smell
11%
wheezing
11%
White blood cell count increased
11%
Hair loss
11%
Tachycardia
10%
Thick saliva
10%
Pain
10%
Infection
10%
Neutrophil count increased
10%
AST increased
10%
aspiration
10%
creatinine decreased
10%
Hyperpigmentation
10%
Nocturia
10%
Trismus
10%
Urinary urgency
8%
Polydipsia
8%
Jaw Pain
8%
chest pain
8%
Sensory change
8%
Neck edema
8%
Weight gain
8%
Allergic rhinitis
7%
Hypothyroidism
7%
chills
7%
Dyspepsia
7%
dysphonia
7%
Leukocytosis
7%
Lung infection
7%
Parathesia
7%
Ulceration
7%
Urinary tract infection
7%
Orthopnea
7%
Skin hyperpigmentation
6%
Stomal pain
6%
Dyspnea
6%
altered mental status
6%
Hypophosphatemia
6%
Hypoglycemia
6%
Salivary duct inflammation
6%
nausea
6%
confusion
6%
congestion
6%
dyspnea
6%
dysuria
6%
Facial rash
6%
Hemoptysis
6%
Hot flashes
6%
LE edema
6%
Night sweats
6%
Weakness
4%
Bloating
4%
Itching
4%
alkaline phosphate decreased
4%
Pruritus
4%
Hypochloremia
4%
G tube dysfunction
4%
Neuropathy
4%
Shortness of breath
4%
Chronic Kidney Disease
4%
decreased appetite
4%
Diabetes
4%
Dry Skin
4%
Fracture
4%
High cholesterol
4%
Hypernatremia
4%
Skin disorder- other
4%
Tremors
4%
ALT decreased
4%
Sleep apnea
4%
Syncope
3%
alkaline phosphatase increased
3%
bloody secretion
3%
Focal weakness
3%
G tube placement
3%
Hypophosphorous
3%
Pain of skin
3%
Platelet count increased
3%
Peripheral sensory neuropathy
3%
Rash acneiform
3%
Skin erythema
3%
Stridor
3%
febrile neutropenia
3%
Acute kidney injury
3%
Pain in extremity
3%
altered sensation
3%
appetite change
3%
Oral thrush
3%
easy bruising
3%
hyponatremia
3%
Ear infection
3%
elevated bilirubin
3%
Neoplasms benign - other
3%
ALP increased
3%
Arthralgia
3%
Arthritis
3%
Coronary Artery Disease
3%
Cellulitis
3%
change in mole
3%
Decreased platelet count
3%
decreased WBC
3%
ear congestion
3%
emesis
3%
Epistaxis
3%
Facial swelling
3%
Hernia
3%
Hiccups
3%
Hip pain
3%
Hypersalivation
3%
Knee pain
3%
Leukoplakia
3%
Lymphadenopathy
3%
Sinusitis
3%
Toothache
3%
Upper respiratory infection
3%
Oral Hemorrhage
3%
Oral Mucositis
3%
sepsis
3%
Atypical Chest Pain
3%
dypsnea
3%
Gastroparesis
3%
GERD
3%
Hearing impaired
3%
Heartburn
3%
Hematuria
3%
Skin infection
3%
Speech change
3%
Telangiectasia
1%
Elevated prothrombin
1%
Right chin pain
1%
Red eyes
1%
breast swelling
1%
R Otalgia
1%
Stoma site infection
1%
fever
1%
Aortic injury
1%
Bradycardia
1%
Abdominal distension
1%
Hypercapnic Respiratory Failure
1%
aphonia
1%
bladder incontinence
1%
abscess of chin
1%
Albumin Decreased
1%
Acneform rash
1%
breast pain
1%
Flushing
1%
Oral lesions
1%
Oropharyngeal edema
1%
Hypoxia
1%
Infections and infestations - other, COVID-19
1%
Infusion related reaction
1%
rectal fissue
1%
Bladder prolapse
1%
Right ear pain
1%
Pulmonary embolism
1%
Rectal pain
1%
Reflux
1%
Respiratory disorder- other
1%
Right arm pain
1%
Right eye pain
1%
Right inguinal hernia
1%
acute mescenteric ischemia
1%
Neutropenia
1%
Right jaw pain
1%
Allergic Reaction
1%
Pneumonitis
1%
Rib pain
1%
BCC Nose
1%
Pallor
1%
Respiratory failure
1%
acne vulgaris
1%
Oral hemorrhage
1%
rectal bleeding
1%
Flank Pain
1%
Influenza (flu-like symptoms)
1%
Otalgia
1%
Delirium
1%
Anaerobic infection
1%
bleeding from mouth
1%
Otic pain (L ear)
1%
Azotemia
1%
Fibromyalgia
1%
Overdose
1%
dermatitis
1%
Hyperthyroid
1%
Inflammation
1%
fatigue
1%
AV block 1st Degree
1%
bite wound
1%
bowel incontinence
1%
Oral dysesthesia
1%
Gastroesophageal reflux
1%
Rhonchus
1%
elevated CO2
1%
Nervous system disorder - other
1%
Wound complication
1%
Ear disorder - other
1%
Peripheral neuropathy
1%
Edema limbs
1%
elevated ANC
1%
Photophobia
1%
Radiation ulceration
1%
Rash maculo-papular
1%
Saliva pooling
1%
Salivary inflammation
1%
Scoliosis
1%
Sexual dysfunction
1%
Sinus pressure
1%
Sinus tachycardia
1%
elbow pain
1%
hypernatremia
1%
hypotensive
1%
hypoxia
1%
agitated
1%
Arm pain
1%
Bronchitis
1%
calcium count increased
1%
Cardiac troponin I increased
1%
cervical stenosis of spine
1%
cervicalgia
1%
Cheilitis
1%
Chest congestion
1%
chest tightness
1%
chest wall pain
1%
contact dermatitis
1%
cystitis
1%
decreased urine output
1%
dental infection
1%
discoloration of tongue
1%
Discolored discharge
1%
double vision
1%
dry cough
1%
Dsyphagia
1%
DVT
1%
Dysesthesia
1%
ear ache
1%
elevated WBC
1%
esophagitis
1%
eye disorder- other
1%
Eye pain
1%
Eye redness
1%
Facial edema
1%
Factor V
1%
Fecal incontinence
1%
Foot pain
1%
Hematochezia (rectal bleeding)
1%
Hemorrhoidal hemorrhage
1%
Hyperchloride
1%
Hyperlipidemia
1%
Hyperphosphatemia
1%
Injury, other, (mild fall injury)
1%
Jaw Spasm
1%
L Elbow Pain
1%
L knee pain
1%
Laryngeal Inflammation
1%
Laryngitis
1%
Leukopenia
1%
Low total protein
1%
Lower extremity pain
1%
Lumbar stenosis
1%
Lump on abdomen
1%
Macular rash
1%
Muscle spasm
1%
Musculoskeletal disorder - other
1%
Mediastinal fistula
1%
Memory loss
1%
Mental confusion
1%
Middle-ear infection
1%
Migraines
1%
Mild odynophagia
1%
Mouth pain
1%
Mouth sores
1%
Mucosal infection
1%
Nocturnal "sweats"
1%
Non-cardiac chest pain
1%
Nose bleeds
1%
Obesity
1%
Palpitations
1%
Papulopustular rash
1%
Phlebitis
1%
Skin lesion
1%
Total bilirubin elevated
1%
Total protein decreased
1%
Tracheitis
1%
TSH elevated
1%
Tumor pain
1%
Urinary incontinence
1%
Urinary retention
1%
Urine output decreased
1%
Velopharyngeal insufficiency (VPI)
1%
Xerostomia
1%
Abdominal Pain
1%
Acute Encephalopathy
1%
Neoplasm of unknown etiology
1%
Neutropenic Fever
1%
Opioid Overdose
1%
parethesia
1%
Radiation Dermatitis
1%
seizure
1%
Severe systemic inflammatory response syndrome
1%
Skin infection (cellulitis )
1%
alopecia
1%
asthenia
1%
asthma
1%
Atrial Fibrillation
1%
Gastrointestinal disorders - other, melena
1%
Gingival ulceration
1%
Hallucinations
1%
Heat intolerance
1%
Skin pigmentation
1%
Skin rash
1%
Skin ulceration
1%
Syncopal
1%
Tachypnea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Radiation Therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment3 Interventions
This is a multicenter phase II toxicity study of pleurectomy/decortication (P/D) followed by adjuvant chemotherapy and Intensity Modulated Radiation Therapy (IMRT) to the pleura in patients with malignant pleural mesothelioma. Alternatively, chemotherapy may be administered in the neoadjuvant setting prior to P/D, followed by IMRT. Patients deemed resectable at the time of enrollment will undergo P/D with the goal of a macroscopic complete resection (MCR). Those with disease progression or severe toxicity will stop chemotherapy and undergo a PET scan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pleurectomy/Decortication
2007
Completed Phase 1
~150
Intensity Modulated Radiation Therapy
2017
Completed Phase 2
~490
Find a Location
Who is running the clinical trial?
Mayo ClinicOTHER
3,205 Previous Clinical Trials
3,766,719 Total Patients Enrolled
9 Trials studying Mesothelioma
769 Patients Enrolled for Mesothelioma
Brigham and Women's HospitalOTHER
1,608 Previous Clinical Trials
11,469,812 Total Patients Enrolled
6 Trials studying Mesothelioma
542 Patients Enrolled for Mesothelioma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,555 Total Patients Enrolled
19 Trials studying Mesothelioma
732 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 80 years old.My organs are functioning well according to my recent lab tests.My lung function test shows at least 35% efficiency.The amount of bilirubin in your blood is not too high.My liver tests are within normal limits, unless I've had chemotherapy.I am mostly self-sufficient and active.Your lung function should be at least 40% of what is expected for someone with similar characteristics as you.Your platelet count should be at least 100,000 per microliter of blood.My cancer has more than 10% sarcomatoid or desmoplastic features.I have had treatments directly in my chest cavity, except for pleurodesis.I use oxygen all the time.My cancer prevents less invasive radiation therapy due to its size.I am scheduled for or have had a surgery to remove a lung and surrounding tissue.I am currently on medication for an active infection.I do not have any active cancer except for skin cancer.I have fluid buildup in my body that can't be managed with drainage.I do not have sudden heart failure.My cancer is either epithelioid or biphasic with less than 10% sarcomatoid.I may need a special kidney scan before radiation due to concerns about my kidney function.My cancer has not spread to other parts of my body.I will have any significant fluid in my chest drained before starting chemotherapy.I am not using any form of birth control.My diagnosis of stage I-III malignant pleural mesothelioma is confirmed by a pathology report.Breathing tests:I've had chest radiation that now prevents certain lung treatments.I understand the need to avoid pregnancy and not breastfeed during the study due to the risk to an unborn baby.I had a kidney removed on the opposite side of my cancer.You have enough infection-fighting white blood cells.
Research Study Groups:
This trial has the following groups:- Group 1: 1
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.
Does this therapy differ from other types of radiation treatments?
"Intensity Modulated Radiation Therapy was first utilized in a 1997 study at City of Hope Comprehensive Cancer Center. A total of 1,772 have completed similar clinical trials since then. As of now, there are 1,211 active studies underway--a number of which are based in Harrison, Minnesota."
Answered by AI
Could you please list the risks associated with Intensity Modulated Radiation Therapy?
"Intensity Modulated Radiation Therapy received a score of 2 from our Power team. This is because, while there is some safety data available, there is currently no evidence that this intervention is effective."
Answered by AI
At how many different research facilities is this study being conducted?
"There are a total of 12 medical centres enrolling patients in this trial, with locations including the Memorial Sloan Kettering West Harrison in Harrison, Mayo Clinic Cancer Center in Rochester, and Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center in Sleepy Hollow."
Answered by AI
What Intensity Modulated Radiation Therapy most often used to target?
"Intensity Modulated Radiation Therapy is most commonly used as an initial treatment, but it has also been shown to help patients with advanced thymoma, advanced testicular cancer, carcinoma, and neuroendocrine."
Answered by AI
Does this research study have an age restriction?
"The age range that is able to enroll in this program starts at 18 years old and stops at 80 years old."
Answered by AI
Are recruitment efforts for this clinical trial still underway?
"This trial is not currently recruiting. It was originally posted on 10/11/2008 and was last updated on 5/9/2022. However, if you are looking for other studies, there are 158 trials actively recruiting patients with mesothelioma and 1211 studies for Intensity Modulated Radiation Therapy that are searching for patients right now."
Answered by AI
How many test subjects are needed for this clinical trial?
"Although this study is not presently looking for candidates, it was last updated on May 9th, 2022. If you are interested in other trials, there are currently 1211 trials for Intensity Modulated Radiation Therapy and 158 trials actively admitting patients with mesothelioma."
Answered by AI
Could I potentially qualify to be a research subject in this experiment?
"The ideal candidate for this trial would be 65 patients with mesothelioma between the ages of 18 and 80 that have either epithelioid or biphasic histology subtype. However, if there is evidence of metastatic disease or renal function concerns, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney."
Answered by AI
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