IRB Study Number S1827
Status Recruiting
Institute Taussig Cancer Institute
Description
1.1 Primary Objective
a. To evaluate whether overall survival (OS) with MRI surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).
1.2 Secondary Objectives
a. To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms.
b. To compare brain-metastasis-free survival between the arms.
c. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease.
d. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms.
e. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms.
f. To compare the frequency and severity of toxicities between the two arms.
Inclusion Criteria
5.1 Disease Related Criteria
a. Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC).
b. Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease. Patient also must not have a history of brain metastases or leptomeningeal disease.
5.2 Prior/Concurrent Therapy Criteria
a. Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating physician. Patients with LS-SCLC must have completed platinum-based chemotherapy and either definitive thoracic radiotherapy (including SBRT for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician but is not required. Patients with ES-SCLC must have completed the platinum-based chemotherapy component of their treatment course.
b. All adverse events from prior treatment must have resolved to ≤ Grade 2 (CTCAE Version 5.0) prior to randomization.
c. Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. Systemic imaging (CT including the chest +/- abdomen/pelvis or PET/CT) must be performed within 42 days prior to randomization.
d. No more than 16 weeks may have elapsed between Day 1 of the last cycle of chemotherapy and randomization.
e. Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy. Patients who have undergone prior stereotactic radiosurgery for benign tumors or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis. Please contact Dr. Chad Rusthoven at chad.rusthoven@cuanschutz.edu for inquiries.
5.3 Clinical/Laboratory Criteria
a. Patient must be ≥ 18 years of age.
b. Patient must have Zubrod Performance Status of 0-2 (see Section 10.9).
c. Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies.
d. Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
e. Patient must not have other metastatic malignancies requiring current active treatment.
f. Patient must not have any severe active comorbidities, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within 3 months prior to randomization
• Transmural myocardial infarction within 3 months prior to randomization
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
• Acute severe exacerbation of chronic obstructive pulmonary disease or other acute respiratory illness precluding study therapy at the time of randomization
• Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease
• HIV positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 16 weeks prior to randomization. Note also that HIV testing is not required for eligibility for this protocol.
g. Patient must not be pregnant because of fetal risks from radiation exposure. Men must have agreed to use an effective contraceptive method during PCI and for six months after completing PCI. Women of reproductive potential must have agreed to use an effective contraceptive method during PCI. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.
5.4 Additional Criteria
a. Patients registered by sites located in the United States who speak English must agree to complete cognitive function testing as outlined in Section 15.1 at the protocol specified timepoints. Patients registered by sites located in Canada who speak English or French must agree to complete the cognitive function testing as outlined in Section 15.1 at the protocol specified timepoints.
b. Patient must be offered the opportunity to have specimens submitted for banking (see Section 15.4).
c. Patients registered by sites located in the United States and Canada who can complete the Quality of Life Instruments in English, Spanish, or French, must agree to participate in the questionnaires as outlined in section 15.4 at the protocol specified timepoints.
NOTE: Patients enrolled prior to the release and implementation of Revision #3 are not eligible for the Quality of Life study.
5.5 Regulatory Criteria
a. Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
b. As a part of the OPEN randomization process (see Section 13.3 for OPEN access instructions) the treating institution’s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
Exclusion Criteria
Exclusion Criteria Not Available
