← Back to Search

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

No Placebo-Only Group

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.

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.

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...

I am between 18 and 80 years old.

Select...

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.

Select...

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:

Select...

My cancer has more than 10% sarcomatoid or desmoplastic features.

Select...

I have had treatments directly in my chest cavity, except for pleurodesis.

Select...

I use oxygen all the time.

Select...

My cancer prevents less invasive radiation therapy due to its size.

Select...

I am scheduled for or have had a surgery to remove a lung and surrounding tissue.

Select...

I am currently on medication for an active infection.

Select...

I do not have any active cancer except for skin cancer.

Select...

I have fluid buildup in my body that can't be managed with drainage.

Select...

I do not have sudden heart failure.

Select...

I am not using any form of birth control.

Select...

I've had chest radiation that now prevents certain lung treatments.

Select...

I had a kidney removed on the opposite side of my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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%

depression

21%

back pain

21%

Hypomagnesemia

21%

creatinine increased

19%

Rash

19%

dysphagia

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%

blurred vision

15%

Snoring

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%

Pain

10%

Infection

10%

Thick saliva

10%

Neutrophil count increased

10%

AST increased

10%

aspiration

10%

creatinine decreased

10%

Hyperpigmentation

10%

Nocturia

10%

Trismus

10%

Urinary urgency

Polydipsia

Jaw Pain

chest pain

Sensory change

Neck edema

Weight gain

Allergic rhinitis

Hypothyroidism

chills

Dyspepsia

dysphonia

Leukocytosis

Lung infection

Parathesia

Ulceration

Urinary tract infection

Orthopnea

Skin hyperpigmentation

Dyspnea

Hypoglycemia

Stomal pain

altered mental status

Hypophosphatemia

Salivary duct inflammation

nausea

confusion

congestion

dyspnea

dysuria

Facial rash

Hemoptysis

Hot flashes

LE edema

Night sweats

Weakness

alkaline phosphate decreased

Bloating

Hypochloremia

Itching

G tube dysfunction

Pruritus

Neuropathy

Shortness of breath

Chronic Kidney Disease

decreased appetite

Diabetes

Dry Skin

Fracture

High cholesterol

Hypernatremia

Skin disorder- other

Tremors

ALT decreased

Sleep apnea

Syncope

Oral thrush

Rash acneiform

bloody secretion

Pain of skin

Hypophosphorous

Acute kidney injury

appetite change

easy bruising

febrile neutropenia

Pain in extremity

alkaline phosphatase increased

Peripheral sensory neuropathy

altered sensation

Focal weakness

G tube placement

Platelet count increased

Skin erythema

Stridor

hyponatremia

Ear infection

elevated bilirubin

Neoplasms benign - other

ALP increased

Arthralgia

Arthritis

Coronary Artery Disease

Cellulitis

change in mole

Decreased platelet count

decreased WBC

ear congestion

emesis

Epistaxis

Facial swelling

Hernia

Hiccups

Hip pain

Hypersalivation

Knee pain

Leukoplakia

Lymphadenopathy

Sinusitis

Toothache

Upper respiratory infection

Oral Hemorrhage

Oral Mucositis

sepsis

Atypical Chest Pain

dypsnea

Gastroparesis

GERD

Hearing impaired

Heartburn

Hematuria

Skin infection

Speech change

Telangiectasia

Hypoxia

rectal fissue

Oral lesions

Influenza (flu-like symptoms)

Respiratory failure

Azotemia

bowel incontinence

rectal bleeding

Neutropenia

Bladder prolapse

Right arm pain

Hyperthyroid

breast pain

Infections and infestations - other, COVID-19

Otic pain (L ear)

R Otalgia

Reflux

Oropharyngeal edema

Otalgia

BCC Nose

Bradycardia

AV block 1st Degree

bleeding from mouth

Respiratory disorder- other

dental infection

breast swelling

Rhonchus

Pulmonary embolism

Oral dysesthesia

acute mescenteric ischemia

Allergic Reaction

Delirium

fatigue

Oral hemorrhage

Red eyes

bite wound

elevated CO2

abscess of chin

Inflammation

Rib pain

aphonia

bladder incontinence

Stoma site infection

Albumin Decreased

Abdominal distension

fever

Hypercapnic Respiratory Failure

Pallor

Rectal pain

dermatitis

Infusion related reaction

Elevated prothrombin

Acneform rash

acne vulgaris

Overdose

Anaerobic infection

Aortic injury

Fibromyalgia

Flank Pain

Flushing

Gastroesophageal reflux

Pneumonitis

Right chin pain

Right ear pain

Right eye pain

Right inguinal hernia

Right jaw pain

Nervous system disorder - other

Wound complication

Ear disorder - other

Peripheral neuropathy

Edema limbs

elevated ANC

Photophobia

Radiation ulceration

Rash maculo-papular

Saliva pooling

Salivary inflammation

Scoliosis

Sexual dysfunction

Sinus pressure

Sinus tachycardia

elbow pain

hypernatremia

hypotensive

hypoxia

agitated

Arm pain

Bronchitis

calcium count increased

Cardiac troponin I increased

cervical stenosis of spine

cervicalgia

Cheilitis

Chest congestion

chest tightness

chest wall pain

contact dermatitis

cystitis

decreased urine output

discoloration of tongue

Discolored discharge

double vision

dry cough

Dsyphagia

DVT

Dysesthesia

ear ache

elevated WBC

esophagitis

eye disorder- other

Eye pain

Eye redness

Facial edema

Factor V

Fecal incontinence

Foot pain

Hematochezia (rectal bleeding)

Hemorrhoidal hemorrhage

Hyperchloride

Hyperlipidemia

Hyperphosphatemia

Injury, other, (mild fall injury)

Jaw Spasm

L Elbow Pain

L knee pain

Laryngeal Inflammation

Laryngitis

Leukopenia

Low total protein

Lower extremity pain

Lumbar stenosis

Lump on abdomen

Macular rash

Muscle spasm

Musculoskeletal disorder - other

Mediastinal fistula

Memory loss

Mental confusion

Middle-ear infection

Migraines

Mild odynophagia

Mouth pain

Mouth sores

Mucosal infection

Nocturnal "sweats"

Non-cardiac chest pain

Nose bleeds

Obesity

Palpitations

Papulopustular rash

Phlebitis

Skin lesion

Total bilirubin elevated

Total protein decreased

Tracheitis

TSH elevated

Tumor pain

Urinary incontinence

Urinary retention

Urine output decreased

Velopharyngeal insufficiency (VPI)

Xerostomia

Abdominal Pain

Acute Encephalopathy

Neoplasm of unknown etiology

Neutropenic Fever

Opioid Overdose

parethesia

Radiation Dermatitis

seizure

Severe systemic inflammatory response syndrome

Skin infection (cellulitis )

alopecia

asthenia

asthma

Atrial Fibrillation

Gastrointestinal disorders - other, melena

Gingival ulceration

Hallucinations

Heat intolerance

Skin pigmentation

Skin rash

Skin ulceration

Syncopal

Tachypnea

100%

80%

60%

40%

20%

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