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Platinum-based Chemotherapy

Surgery + Chemotherapy + IMRT for Mesothelioma

Phase 2
Waitlist Available
Led By Annemarie Shepherd, 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
Patients must have a pathologically confirmed diagnosis either at MSKCC or at the participating site of stage I-III malignant pleural mesothelioma
Epithelioid or biphasic histology subtype (Note: patients with biphasic histology can have < 10% sarcomatoid)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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 below
Select...
My diagnosis of stage I-III malignant pleural mesothelioma is confirmed by a pathology report.
Select...
My cancer is either epithelioid or biphasic with less than 10% sarcomatoid.
Select...
My cancer has not spread to other parts of my body.
Select...
I am between 18 and 80 years old.
Select...
I am mostly self-sufficient and active.
Select...
My lung function test shows at least 35% efficiency.
Select...
I may need a special kidney scan before radiation due to concerns about my kidney function.
Select...
My organs are functioning well according to my recent lab tests.
Select...
My liver tests are within normal limits, unless I've had chemotherapy.

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%
Hypomagnesemia
21%
creatinine increased
21%
depression
21%
back pain
19%
dysphagia
19%
Rash
19%
Voice alteration
18%
Hypoalbuminemia
18%
Edema
18%
Hearing loss
17%
Hypotension
17%
Fever
17%
Hyperkalemia
17%
Throat pain
17%
Urinary frequency
15%
Acid Reflex
15%
ALT increased
15%
Snoring
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%
Infection
10%
Thick saliva
10%
Neutrophil count increased
10%
AST increased
10%
aspiration
10%
creatinine decreased
10%
Hyperpigmentation
10%
Nocturia
10%
Pain
10%
Trismus
10%
Urinary urgency
8%
Jaw Pain
8%
chest pain
8%
Sensory change
8%
Polydipsia
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%
Dyspnea
6%
altered mental status
6%
Stomal pain
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%
alkaline phosphate decreased
4%
Itching
4%
Hypochloremia
4%
Neuropathy
4%
Pruritus
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%
Bloating
4%
G tube dysfunction
4%
Sleep apnea
4%
Syncope
3%
altered sensation
3%
appetite change
3%
bloody secretion
3%
Hypophosphorous
3%
Skin erythema
3%
Pain in extremity
3%
Pain of skin
3%
febrile neutropenia
3%
Oral thrush
3%
Stridor
3%
Platelet count increased
3%
alkaline phosphatase increased
3%
Focal weakness
3%
Acute kidney injury
3%
Rash acneiform
3%
easy bruising
3%
hyponatremia
3%
Ear infection
3%
elevated bilirubin
3%
Neoplasms benign - other
3%
Peripheral sensory neuropathy
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%
G tube placement
3%
Gastroparesis
3%
GERD
3%
Hearing impaired
3%
Heartburn
3%
Hematuria
3%
Skin infection
3%
Speech change
3%
Telangiectasia
1%
Pneumonitis
1%
acne vulgaris
1%
acute mescenteric ischemia
1%
Inflammation
1%
Delirium
1%
fever
1%
Hypercapnic Respiratory Failure
1%
abscess of chin
1%
Abdominal distension
1%
Acneform rash
1%
Anaerobic infection
1%
Aortic injury
1%
aphonia
1%
breast pain
1%
bowel incontinence
1%
breast swelling
1%
dermatitis
1%
Stoma site infection
1%
Bradycardia
1%
Albumin Decreased
1%
Right inguinal hernia
1%
Right jaw pain
1%
Infections and infestations - other, COVID-19
1%
Right ear pain
1%
Oropharyngeal edema
1%
Rib pain
1%
Neutropenia
1%
Influenza (flu-like symptoms)
1%
Right arm pain
1%
Infusion related reaction
1%
Right eye pain
1%
fatigue
1%
Allergic Reaction
1%
Hypoxia
1%
Hyperthyroid
1%
Flank Pain
1%
Right chin pain
1%
rectal fissue
1%
Rectal pain
1%
Red eyes
1%
Reflux
1%
Bladder prolapse
1%
Respiratory disorder- other
1%
Respiratory failure
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%
Pulmonary embolism
1%
R Otalgia
1%
Radiation ulceration
1%
Rash maculo-papular
1%
rectal bleeding
1%
Rhonchus
1%
Saliva pooling
1%
Salivary inflammation
1%
Scoliosis
1%
Sexual dysfunction
1%
Sinus pressure
1%
Sinus tachycardia
1%
elbow pain
1%
Elevated prothrombin
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%
Fibromyalgia
1%
Flushing
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%
Oral dysesthesia
1%
Oral hemorrhage
1%
Oral lesions
1%
Otalgia
1%
Otic pain (L ear)
1%
Overdose
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%
AV block 1st Degree
1%
Azotemia
1%
BCC Nose
1%
bite wound
1%
bladder incontinence
1%
bleeding from mouth
1%
Gastroesophageal reflux
1%
Gastrointestinal disorders - other, melena
1%
Gingival ulceration
1%
Hallucinations
1%
Heat intolerance
1%
Pallor
1%
Skin pigmentation
1%
Skin rash
1%
Skin ulceration
1%
Syncopal
1%
Tachypnea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Radiation Therapy

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: 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?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,920 Previous Clinical Trials
590,554 Total Patients Enrolled
19 Trials studying Mesothelioma
745 Patients Enrolled for Mesothelioma
M.D. Anderson Cancer CenterOTHER
2,939 Previous Clinical Trials
1,774,028 Total Patients Enrolled
12 Trials studying Mesothelioma
563 Patients Enrolled for Mesothelioma
Princess Margaret Hospital, CanadaOTHER
118 Previous Clinical Trials
38,625 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00715611 — Phase 2
Mesothelioma Research Study Groups: 1
Mesothelioma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00715611 — Phase 2
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00715611 — Phase 2

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
~5 spots leftby Jul 2025