Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence
Condition: Non-Small-Cell Lung Carcinoma
MeSH terms: Pneumonia; Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical research study is to learn if, compared with regular x-ray
      radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis
      (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in
      patients with lung cancer.
    

Detailed description: 
      There are 2 types of radiation treatment being used in this study. One type of treatment is
      proton therapy. Proton therapy is a type of radiation therapy that uses a beam of proton
      particles (similar to getting an x-ray) to send radiation inside the body to the tumor. The
      other type of treatment is Image-Guided Adaptive Photon Therapy (IGAPT). IGAPT is a therapy
      that uses images to help guide the delivery of photon therapy to the tumor. Both of these
      types of radiation treatment are believed to help doctors to give a full dose of radiation
      treatment to the tumor while not damaging as much of the healthy tissue around it.

      Study Groups If you are found to be eligible to take part in this study, you will go through
      the standard radiation treatment planning procedure, called the "marking session." After the
      marking session, a standard photon therapy plan (called Intensity Modulated Radiation
      Therapy, or IMRT) and a proton plan will be developed. If the radiation oncologist thinks
      that both the photon and proton plans are acceptable, you will then be randomly assigned to 1
      of 2 groups. Participants in Group 1 will receive photon therapy. Participants in Group 2
      will receive proton therapy.

      The first 20 participants will have an equal chance to be assigned to either group. After at
      least 20 participants have been enrolled and there has been at least 1 occurrence of
      pneumonitis and/or tumor recurrence in each treatment Group, the risk of pneumonitis and/or
      tumor recurrence in all previous participants will be evaluated for each treatment Group, and
      that information will be used to calculate the chances of being assigned to either Group 1 or
      Group 2. This calculation will be updated after each occurrence of pneumonitis and/or tumor
      recurrence and after each participant returns for a follow-up visit. Once these calculations
      are begun, everyone who joins the study from that point on will be more likely to be assigned
      to the treatment Group that appears to be better in terms of pneumonitis and/or tumor
      recurrence.

      If the tumor is too large and the standard radiation treatment plan created during the
      marking session is found not to be acceptable, and the radiation oncologist thinks radiation
      treatment it is necessary, you will still remain on study and be assigned to a third group.
      If you are assigned to Group 3, you will receive proton or photon treatment at a lower dose
      level and/or reduced length of radiation.

      If you are assigned to Group 2 and your insurance provider denies reimbursement, you may
      chose not to receive proton therapy and receive photon therapy instead. If you chose to
      receive photon therapy, you will be in Group 4.

      Radiation Therapy Administration Both radiation therapy treatments (photon and proton) are
      given through a radiation machine called an accelerator. The radiation therapy administration
      process is very similar to the way that a CT scan is performed. You will lay on a table and
      the treatment machine rotates around you without touching your body. Each daily treatment
      should take about 20-30 minutes to complete. Most of this time is used to position you
      correctly before the machine is turned on. The actual time used to give the radiation should
      take about 3-5 minutes each day.

      While you are on this study and if you are in Groups 1 or 2, you will receive a total of 37
      radiation treatments. Radiation is given 5 days a week for about 7 1/2 weeks.

      If you are in Group 1, you will receive photon radiation treatment in the main hospital.

      If you are in Group 2, you will receive proton therapy in the proton treatment center (PTC).

      If you are in Group 3, you will receive either photon or proton therapy, whichever your
      doctor decides is better for you, for 6-7 1/2 weeks. If your doctor decides that photon
      therapy is better you will receive your treatment in the main hospital. If your doctor
      decides that proton therapy is better you will receive your treatment in the Proton Therapy
      Center.

      If you are in Group 4, you will receive Photon radiation treatment in the main hospital.

      Chemotherapy You will receive carboplatin and paclitaxel chemotherapy 1 time a week over 7
      weeks. Each treatment will last 3-4 hours. Paclitaxel will be given by vein over 1 hour and
      carboplatin will be given by vein over 30 minutes. You will receive this chemotherapy
      combination with radiation therapy, as part of your treatment on this study.

      Your chemotherapy may also be decided by your treating medical oncologist as long as the
      therapy is allowed by the study.

      Study Visits During Chemoradiation

      At least 1 time each week for all study participants, you will have study tests performed.
      During this weekly study visit, the following tests and procedures will be performed:

      You will have a physical exam. You will be asked about any side effects you may have
      experienced. Blood (about 2 teaspoons) will be drawn for routine tests.

      If the study doctor thinks it is needed, you will have a PET/CT scan performed to check the
      status of the disease during Week 4 or 5 of treatment.

      Length of Study You will remain on study as long you are benefiting. You will be taken off
      study early if the disease gets worse, you experience intolerable side effects, or your
      doctor thinks that it is no longer in your best interest to receive the study treatment.

      Follow-Up Visits After you have completed chemoradiation, the study staff or study nurse will
      contact you 1 time each month to ask you about any symptoms you may have until 6 months after
      chemoradiation. Each phone call should last about 10 minutes.

      You will have your first follow-up visit 4-8 weeks after you have completed chemoradiation.
      You will have additional follow-up visits every 3-4 months for 3 years, every 6 months for
      the next 2 years, and then 1 time every year after that.

      At the first and second follow-up visit the following tests and procedures will be performed:

      You will have positron emission tomography (PET)/computed tomography (CT) scans and single
      proton emission tomography (SPECT) scans to check the status of your lungs and heart if the
      radiation or medical oncologist thinks it is necessary.

      Blood (about 1 teaspoon) will be drawn for routine tests.

      If the radiation oncologist or medical oncologist thinks it is needed, at the follow-up
      visits, you will have breathing function tests performed to check your lung function for up
      to 1 year after the study treatment is complete. For this test, the radiation oncologist,
      medical oncologist or study nurse will have you breathe into a special machine. The radiation
      oncologist or medical oncologist will decide how many tests are to be performed each time.

      PET/CT and SPECT scans will be performed again at any time the radiation oncologist or
      medical oncologist thinks they are needed.

      Other tests may be performed if the study doctor (radiation oncologist, medical oncologist,
      surgeon or pulmonologist) thinks they are needed.

      This is an investigational study. Both proton radiotherapy and IGAPT are FDA approved for the
      treatment of lung cancer.

      Up to 250 patients will take part in this multi-center research study. Up to 205 will be
      enrolled at M. D. Anderson.
    

Intervention name(s): Photon Therapy; Proton Therapy; Paclitaxel; Carboplatin
Intervention type(s): Radiation; Radiation; Drug; Drug
Intervention description(s): Group 1: 74 Gy 37 radiation treatments, given 5 days a week for about 7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete.; Group 2: 74 Gy in 2 CGE per fraction given 5 days a week for about 7 1/2 weeks.
Group 3: 66 Gy with conventional fractionation given 5 days a week for about 6-7 1/2 weeks.
Each daily treatment should take about 20-30 minutes to complete.; 50 mg/m2 by vein 1 time each week for 7 weeks.; AUC 2 by vein 1 time each week for 7 weeks.
Other intervention name(s): Taxol; Paraplatin
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Locally-advanced non-small-cell lung carcinoma; NSCLC; Lung Cancer; Image-Guided Adaptive Conformal Photon; Proton Therapy; Chemotherapy; Treatment Related Pneumonitis