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Platinum-based Chemotherapy

Surgery + Chemotherapy + IMRT for Mesothelioma

Phase 2
Waitlist Available
Led By Charles Simone, 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)
Must not have
> 10% Sarcomatoid or desmoplastic histology
Prior intrapleural therapy (except pleurodesis) or intrapleural therapy at the time of P/D (i.e.: intrapleural chemotherapy, photodynamic therapy, intrapleural betadine)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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 below
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I am between 18 and 80 years old.
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My lung function test shows at least 35% efficiency.
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I am mostly self-sufficient and active.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has more than 10% sarcomatoid or desmoplastic features.
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I have had treatments directly in my chest cavity, except for pleurodesis.
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I use oxygen all the time.
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My cancer prevents less invasive radiation therapy due to its size.
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I am scheduled for or have had a surgery to remove a lung and surrounding tissue.
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I am currently on medication for an active infection.
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I do not have any active cancer except for skin cancer.
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I have fluid buildup in my body that can't be managed with drainage.
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I do not have sudden heart failure.
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I am not using any form of birth control.
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I've had chest radiation that now prevents certain lung treatments.
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I had a kidney removed on the opposite side of my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 • NCT03067610
90%
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%
ALT increased
15%
Acid Reflex
15%
blurred vision
15%
Snoring
15%
Fall
15%
Joint pain
15%
Myalgias
14%
elevated creatinine
14%
Hypocalcemia
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%
Infection
10%
Pain
10%
Thick saliva
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%
altered mental status
6%
Dyspnea
6%
Hypophosphatemia
6%
Stomal pain
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%
Pruritus
4%
Bloating
4%
alkaline phosphate decreased
4%
G tube dysfunction
4%
Hypochloremia
4%
Itching
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%
Hypophosphorous
3%
Pain in extremity
3%
appetite change
3%
Acute kidney injury
3%
febrile neutropenia
3%
altered sensation
3%
bloody secretion
3%
Focal weakness
3%
G tube placement
3%
Oral thrush
3%
Pain of skin
3%
Peripheral sensory neuropathy
3%
Platelet count increased
3%
Rash acneiform
3%
Stridor
3%
Skin erythema
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%
breast pain
1%
Oropharyngeal edema
1%
Otalgia
1%
Flank Pain
1%
Pulmonary embolism
1%
abscess of chin
1%
Infections and infestations - other, COVID-19
1%
Azotemia
1%
Stoma site infection
1%
Anaerobic infection
1%
breast swelling
1%
Bladder prolapse
1%
Gastroesophageal reflux
1%
Right inguinal hernia
1%
aphonia
1%
Allergic Reaction
1%
BCC Nose
1%
acute mescenteric ischemia
1%
Delirium
1%
fatigue
1%
Hypercapnic Respiratory Failure
1%
Abdominal distension
1%
fever
1%
bowel incontinence
1%
acne vulgaris
1%
Albumin Decreased
1%
bite wound
1%
Bradycardia
1%
Acneform rash
1%
AV block 1st Degree
1%
Aortic injury
1%
bleeding from mouth
1%
bladder incontinence
1%
dermatitis
1%
Elevated prothrombin
1%
Fibromyalgia
1%
Flushing
1%
Influenza (flu-like symptoms)
1%
Hypoxia
1%
Inflammation
1%
Hyperthyroid
1%
Oral dysesthesia
1%
Oral hemorrhage
1%
Infusion related reaction
1%
Neutropenia
1%
Pallor
1%
Pneumonitis
1%
Oral lesions
1%
Otic pain (L ear)
1%
Overdose
1%
rectal fissue
1%
Red eyes
1%
Reflux
1%
Respiratory failure
1%
Rhonchus
1%
Rib pain
1%
R Otalgia
1%
Respiratory disorder- other
1%
Right arm pain
1%
Right chin pain
1%
rectal bleeding
1%
Rectal pain
1%
Right jaw pain
1%
Right ear pain
1%
Right eye pain
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
3,255 Previous Clinical Trials
3,835,341 Total Patients Enrolled
9 Trials studying Mesothelioma
769 Patients Enrolled for Mesothelioma
Brigham and Women's HospitalOTHER
1,628 Previous Clinical Trials
11,474,575 Total Patients Enrolled
6 Trials studying Mesothelioma
542 Patients Enrolled for Mesothelioma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,686 Total Patients Enrolled
19 Trials studying Mesothelioma
732 Patients Enrolled for Mesothelioma

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