Last updated: December 8, 2021
Sponsor: Massachusetts General Hospital
Overall Status: Completed
Phase
N/A
Condition
Non-small Cell Lung Cancer
Carcinoma
Small Cell Lung Cancer
Treatment
N/AClinical Study ID
NCT02394548
15-023
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Participants must meet the following criteria on screening examination to be eligible toparticipate in the study.
- Histologically or cytologically proven diagnosis of NSCLC or SCLC
- NSCLC, patients with clinical stage IIB-IV patients (AJCC, 7th ed.) are eligible, andfor SCLC, limited-stage patients are eligible, if documented to be a candidate fordefinitive radiation and concurrent chemotherapy in the radiation oncologist ormedical oncologist clinic note.
- Stage IV NSCLC patients are eligible only if they have a solitary brainmetastasis
- Patients with non-malignant pleural effusion are eligible. --- If a pleuraleffusion is present, the following criteria must be met to exclude malignantinvolvement:
- When pleural fluid is visible on both the CT scan and on a chest x-ray, apleuracentesis is required to confirm that the pleural fluid iscytologically negative.
- Exudative pleural effusions are excluded, regardless of cytology;
- Effusions that are minimal (ie, not visible on chest x-ray) that are toosmall to safely tap are eligible.
- Gross tumor (primary tumor or involved lymph node) must be within 1 cm of esophagus onthe most recent chest CT scan.
- ECOG performance status 0-1 within 30 days prior to registration;
- Age ≥18
- Women of childbearing potential must indicate that there is not a possibility of beingpregnant at the time of enrollment or have a negative serum pregnancy test prior tothe initiation of radiation therapy.
- Women of childbearing potential and male participants must practice adequatecontraception.
- Patient must provide study-specific informed consent prior to study entry.
Exclusion
Exclusion Criteria: Participants who exhibit any of the following conditions at screening will not be eligiblefor admission into the study.
- Greater than minimal, exudative, or cytologically positive pleural effusions
- Tumor suspected or known to invade the esophagus
- Prior chemotherapy if this precludes administration of concurrent chemotherapy forprotocol treatment. Note that induction chemotherapy is allowed as long as concurrentchemotherapy is possible.
- Prior radiotherapy to the region of the study cancer that would result in overlap ofradiation therapy fields
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note,however, that HIV testing is not required for entry into this protocol. The need toexclude patients with AIDS from this protocol is necessary because the treatmentsinvolved in this protocol may be significantly immunosuppressive. Protocol-specificrequirements may also exclude immuno-compromised patients.
- Pregnancy or women of childbearing potential and men who are sexually active and notwilling/able to use medically acceptable forms of contraception; this exclusion isnecessary because the treatment involved in this study may be significantlyteratogenic.
- Any history of allergic reaction to chemotherapies used
Study Design
Total Participants: 27
Study Start date:
June 01, 2015
Estimated Completion Date:
March 31, 2021
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Newton-Wellesley Hospital
Newton, Massachusetts 02462
United StatesSite Not Available

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