RTOG1308: Comparing Photon Therapy To Proton Therapy To Treat Patients with Lung Cancer

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Basic Trial Information

Phase	Type	Status	Age	Trial IDs
Phase III	Health services research, Treatment	Active	18 and over	RTOG-1308 NCI-2013-01850, NCT01993810

Trial Description

Summary

This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To compare the overall survival (OS) in patients with stage II-IIIB non-small cell lung cancer (NSCLC) after image guided, motion-managed photon radiotherapy (Arm 1) or after image guided, motion-managed proton radiotherapy (Arm 2) both given with concurrent platinum- based chemotherapy.

SECONDARY OBJECTIVES:

I. To compare 2-year progression-free survival (PFS) between the 2 arms.

II. To compare the development of grade 3 or higher adverse events definitely, probably, or possibly related to treatment.

III. To compare differences between the two arms in quality of life (QOL) based primarily on the development of shortness of breath at 6 months and secondarily on the development of sore throat at the end of chemoradiotherapy (chemoRT) (as measured by the lung cancer module of the MD Anderson Symptom Inventory [MDASI-Lung]), as well as breathing related functioning impairments as measured by the Shortness Breath Questionnaire [SOBQ].

IV. To compare cost-effectiveness outcomes between the 2 arms.

V. To compare pulmonary function changes by treatment arms and response.

VI. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout radiation therapy processes, including imaging, simulation, patient immobilization, target and critical structure definition, treatment planning, image guidance and delivery.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo photon beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel* intravenously (IV) over 1 hour and carboplatin* IV weekly during radiation therapy or etoposide IV on days 1-5 and 29-33 and cisplatin IV on days 1, 8, 29, and 36.

ARM II: Patients undergo proton beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel* and carboplatin* or etoposide and cisplatin as in Arm I.

*In both arms, patients who receive paclitaxel and carboplatin must complete consolidation therapy.

CONSOLIDATION THERAPY: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4-8 weeks, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically proven diagnosis of non-small cell lung cancer

Clinical American Joint Committee on Cancer (AJCC) (AJCC, 7th ed.) II, IIIA or IIIB (with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team within 60 days prior to registration; note: for patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and/or a medical oncologist or pulmonologist

Patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor are eligible

Patients who refuse surgery are eligible

Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:

History/physical examination within 30 days prior to registration;

Fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scan for staging within 60 days prior to registration

Magnetic resonance imaging (MRI) scan with contrast of the brain (preferred) or CT scan of the brain with contrast within 60 days prior to registration;

Forced expiratory volume in one second (FEV1) >= 1.0 Liter or >= 40% predicted with or without bronchodilator within 90 days prior to registration;

Patients who meet the criterion above without oxygen (O2), but who need acute (started within 10 days prior to registration) supplemental oxygen due to tumor-caused obstruction/hypoxia are eligible, provided the amount of the O2 needed has been stable

Zubrod performance status 0-1 within 30 days prior to registration

Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

Platelets >= 100,000 cells/mm^3

Hemoglobin >= 9.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable)

Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =< 1.5 upper limit of normal

Total bilirubin =< 1.5 upper limit of normal

Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min estimated by the Cockcroft-Gault formula

Peripheral neuropathy =< grade 1 at the time of registration

Patients with non-malignant pleural effusion are eligible

If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:

When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative
Exudative pleural effusions are excluded, regardless of cytology
Effusions that are minimal (i.e, not visible on chest x-ray) that are too small to safely tap are eligible

Patients must have measurable or evaluable disease

Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration

Women of childbearing potential and male participants must practice adequate contraception

Patient must provide study-specific informed consent prior to study entry

Exclusion Criteria:

Prior invasive malignancy unless disease free for a minimum of 3 years; however, skin cancer and in situ carcinomas of the breast, oral cavity, cervix, and other organs and are permissible

Patients with prior history of either small cell lung cancer or NSCLC regardless of the treatment received

Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable

Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

Severe, active co-morbidity, defined as follows:

Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;

Transmural myocardial infarction within the last 6 months;

Chronic obstructive pulmonary disease exacerbation or other respiratory illness other than the diagnosed lung cancer requiring hospitalization or precluding study therapy within 30 days before registration;

Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol

Unintentional weight loss > 10% within 90 days prior to registration

Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NRG Oncology

National Cancer Institute

Zhongxing Liao, Principal Investigator

Trial Sites

U.S.A.

Illinois

Warrenville

Northwestern Medicine Cancer Center Warrenville

Vinai Gondi
Ph: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org

Vinai Gondi
Principal Investigator

Massachusetts

Boston

Massachusetts General Hospital Cancer Center

Noah Chan H. Choi
Ph: 877-726-5130

Noah Chan H. Choi
Principal Investigator

Danvers

Mass General/North Shore Cancer Center

Noah Chan H. Choi
Ph: 877-726-5130

Noah Chan H. Choi
Principal Investigator