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Comparing Photon Therapy to Proton Therapy to Treat Patients with Lung Cancer

Status
Closed
Cancer Type
Lung Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT01993810
Protocol IDs
RTOG-1308 (primary)
RTOG-1308
NCI-2013-01850
RTOG 1308
Study Sponsor
NRG Oncology

Summary

This 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, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.

Objectives

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.
II. To compare the cardiac toxicity and lymphocyte reduction (lymphopenia) definitely, probably, or possibly related to treatment between the 2 arms.

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 not included above that are 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. If a patients has a hypersensitivity reaction to paclitaxel, patients may receive nab-paclitaxel IV weekly at the discretion of the treating physician. Patients with non-squamous cell cancer may receive pemetrexed IV, and carboplatin IV or cisplatin IV every 21 days.

ARM II: Patients undergo proton beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel* and carboplatin*, etoposide and cisplatin, or pemetrexed and carboplatin or cisplatin (for non-squamous cell cancer patients only) as in Arm I.

*In both arms, patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy.

CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV every 21 days for up to 4 courses.

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

  1. Histologically or cytologically proven diagnosis of non-small cell lung cancer
  2. 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 * Patients who develop local/regional recurrence after surgery for initial Stage I/II NSCLC with a relapse that is re-stage II-III and rendered candidate for definitive concurrent chemoradiation are also eligible * Patients who have received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) are eligible
  3. 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 including resting heart rate; * 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) >= 0.8 liter or >= 35% 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
  4. Zubrod performance status 0-1 within 30 days prior to registration
  5. Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 obtained within 30 days prior to registration
  6. Platelets >= 100,000 cells/mm^3 obtained within 30 days prior to registration
  7. Hemoglobin >= 9.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable), obtained within 30 days prior to registration
  8. Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) within 30 days prior to registration * It is highly recommended but not required that SGOT or SGPT be =< 1.5 upper limit of normal
  9. Total bilirubin within 30 days prior to registration * It is highly recommended but not required that total bilirubin be =< 1.5 upper limit of normal
  10. Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula
  11. Peripheral neuropathy =< grade 1 at the time of registration
  12. 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
  13. Patients must have measurable or evaluable disease
  14. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration
  15. Women of childbearing potential and male participants must practice adequate contraception
  16. Patient must provide study-specific informed consent prior to study entry

Treatment Sites in Georgia

Emory Saint Joseph's Hospital


5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.