Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer

Conditions

• Stage II Non-Small Cell Lung Cancer AJCC v7
• Stage IIA Non-Small Cell Lung Carcinoma AJCC v7
• Stage IIB Non-Small Cell Lung Carcinoma AJCC v7
• Stage III Non-Small Cell Lung Cancer AJCC v7
• Stage IIIA Non-Small Cell Lung Cancer AJCC v7
• Stage IIIB Non-Small Cell Lung Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Durvalumab — BIOLOGICAL
  Given IV
• Etoposide — DRUG
  Given IV
• Paclitaxel — DRUG
  Given IV
• Pemetrexed Disodium — DRUG
  Given IV
• Photon Beam Radiation Therapy — RADIATION
  Undergo photon beam radiation therapy
• Proton Beam Radiation Therapy — RADIATION
  Undergo proton beam radiation therapy
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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, 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.

Key Dates

Start date

Jan 3, 2014

Status verified

Jun 2026

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

330 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (photon beam radiation therapy and chemotherapy)
  Patients undergo photon beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel\* 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. Patients with non-squamous cell cancer may receive pemetrexed IV and carboplatin IV on every 21 days. 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 on day 1 every 21 days for up to 4 courses.
• Experimental: Arm II (proton beam radiation therapy and chemotherapy)
  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 (for non-squamous cell cancer patients only) as in Arm I. 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 on day 1 every 21 days for up to 4 courses.

Primary Outcome Measure

Overall Survival [ Time Frame: From registration until death or last follow-up; analysis occurs after 390 deaths have been reported ]

Locations (30)

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