Intensity-Modulated Scanning Beam Proton Therapy (IMPT) With Simultaneous Integrated Boost (SIB)
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Purpose
The goal of this clinical research study is to learn if the dose of radiation to the tumor but not the surrounding healthy tissue could be increased by using intensity-modulated photon therapy (IMRT) or intensity-modulated proton beam therapy (IMPT).
In Phase I of the study, researchers want to find the highest tolerable dose of IMPT or IMRT that can be given to the tumor.
In Phase II, researchers want to learn if IMPT can help to control the disease compared with standard proton therapy when both are combined with standard chemotherapy. Participants will also receive standard chemotherapy. Proton therapy and photon therapy are types of radiation therapy that are designed to use a beam of proton or photon particles (similar to getting an x-ray) to send radiation inside the body to the tumor.
In IMPT and IMRT, the amount or strength of the protons or photons will be adjusted according to the size, shape, and thickness of the tumor. In this study, the tumor will receive a higher dose by adjusting the energy and scanning time of the protons or photons, which is called simultaneous integrated boost (SIB). The treatment will be done with image guidance. This newer type of radiation is designed to give a higher than standard dose of treatment to the tumor. It is also designed to focus the treatment on the tumor to avoid affecting the healthy tissue around the tumor as much as standard treatments.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Radiation: IMPT + SIB + Chemotherapy Behavioral: Questionnaire Radiation: IMRT + SIB + Chemotherapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Trial of Image-Guided, Intensity-Modulated Photon (IMRT) or Scanning Beam Proton Therapy (IMPT) Both With Simultaneous Integrated Boost (SIB) Dose Escalation to the Gross Tumor Volume (GTV) With Concurrent Chemotherapy for Stage II/III Non-Small Cell Lung Cancer (NSCLC) |
- Maximum Tolerated Dose (MTD) of Image-Guided Intensity-Modulated Photon (IMRT) and Proton Therapy (IMPT) [ Time Frame: 90 days from start of radiation therapy ] [ Designated as safety issue: Yes ]Maximum tolerated dose (MTD) defined as maximum dose at which no more than 30% of patients have acute radiation dose limiting toxicity (DLT), acute radiation toxicity 90 days from day 1 of radiation treatment in regions at risk (including but not limited to lung, esophagus, brachial plexus, or heart) that is definitely or probably related to radiation treatment.
- Progression-Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]Local tumor progression defined as tumor recurrence or progression inside or at the boundary of the volume defined by the 60 Gy(RBE) isodose line.
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IMPT + SIB + Chemotherapy
Phase I Starting IMPT Dose: 60 Gy (RBE) in 30 fractions. Phase I Starting SIB Dose: (72 - 84) Gy (RBE). Fractions given once a day, 5 times a week for six weeks. All patients receive standard concurrent chemotherapy as prescribed by their treating medical oncologist. Symptom questionnaire completion before chemoradiation beings, each week during chemoradiation, each week until 16 weeks after chemoradiation is complete, every other week from Week 16 until 12 weeks after chemoradiation is complete, and at follow-up visits. Dose level 1 of 66-72 Gy(RBE) in 30 fractions used as the planned dose in the Phase II portion of the trial. |
Radiation: IMPT + SIB + Chemotherapy
Phase I Starting Dose: For all SIBVi dose levels, the dose to the PTV will be kept constant at 60 Gy(RBE) in 30 fractions, which is biologically equivalent to 67 Gy(RBE) delivered in 2 Gy(RBE) fractions. We will start the SIB at the lowest dose level to SIBVi to 72 Gy(RBE) (SIBV72) in 30 fractions at 2.4 Gy per fraction. Fractions given once a day, 5 times a week for six weeks. All patients will receive standard concurrent chemotherapy as prescribed by their treating medical oncologist. Dose level 1 of 66-72 Gy(RBE) in 30 fractions used as the planned dose in the Phase II portion of the trial. Other Names:
Behavioral: Questionnaire
Symptom questionnaire completion before chemoradiation beings, each week during chemoradiation, each week until 16 weeks after chemoradiation is complete, every other week from Week 16 until 12 weeks after chemoradiation is complete, and at follow-up visits. The symptom questionnaire should take about 10 minutes to complete each time.
Other Name: Survey
|
|
Experimental: IMRT + SIB + Chemotherapy
Phase I Starting IMRT Dose: 60 Gy (RBE) in 30 fractions. Phase I Starting SIB Dose: (72 - 84) Gy (RBE). Fractions given once a day, 5 times a week for six weeks. Symptom questionnaire completion before chemoradiation beings, each week during chemoradiation, each week until 16 weeks after chemoradiation is complete, every other week from Week 16 until 12 weeks after chemoradiation is complete, and at follow-up visits. All patients receive standard concurrent chemotherapy as prescribed by their treating medical oncologist. Dose level 1 of 66-72 Gy(RBE) in 30 fractions used as the planned dose in the Phase II portion of the trial. |
Behavioral: Questionnaire
Symptom questionnaire completion before chemoradiation beings, each week during chemoradiation, each week until 16 weeks after chemoradiation is complete, every other week from Week 16 until 12 weeks after chemoradiation is complete, and at follow-up visits. The symptom questionnaire should take about 10 minutes to complete each time.
Other Name: Survey
Radiation: IMRT + SIB + Chemotherapy
Phase I Starting IMRT Dose: 60 Gy (RBE) in 30 fractions. Phase I Starting SIB Dose: (72 - 84) Gy (RBE). Fractions given once a day, 5 times a week for six weeks. Dose level 1 of 66-72 Gy(RBE) in 30 fractions used as the planned dose in the Phase II portion of the trial. Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathologically proven diagnosis of unresected stage II-IIIB, or recurrent after surgical resection non-small cell lung cancer
- Suitability for concurrent chemoradiation therapy per treating physician's assessment
- Karnofsky Performance Status (KPS) score >/=70, weight loss <15% in the 3 months before diagnosis
- Prior receipt of induction chemotherapy followed by referral for concurrent chemoradiation is allowed
- Adequate lung function indicated by forced expiratory volume at 1 second (FEV)1 >/=1 L is required
- The primary tumor and/or regional lymph nodes must be evaluable radiographically
- The GTV motion should be </=5 mm or should be reducible to a residual motion of </=5 mm using gating or breath-holding. In addition, the target coverage and normal tissue constraints must be met as specified in protocol accounting for the respiratory motion of anatomy as a whole (not just the tumor).
- Age >/= 18 years
- No prior radiation to the mediastinal structures
- Adequate bone marrow, liver and renal function, as assessed by the following: *Hemoglobin >/=9.0 g/dL *Absolute neutrophil count (ANC) >/=1,500/mm3 *Platelet count >/=100,000/mm3 *Total bilirubin </=1.5 times the upper limit of normal (ULN) *Alanine and aspartate transaminases (ALT and AST) </=2.5 times the ULN (</= 5 x ULN for patients with liver involvement) *Creatinine </=1.5 times ULN
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of MD Anderson Cancer Center (MDACC). The only approved consent form is attached to this protocol.
Exclusion Criteria:
- Prior radiotherapy to any anatomic regions that would result in overlap of radiation dose distribution to critical structures (esophagus, heart, spinal cord, brachial plexus)
- T4 tumor with direct invasion of esophagus, spinal cord, major blood vessel, or heart
- GTV motion >5 mm on four-dimensional computed tomography (4D CT) scanning with or without respiratory management using gating or breath-holding
- Pregnancy (because the treatment involves unforeseeable risks to the participant and to the embryo or fetus)
- Patients of childbearing potential must practice appropriate contraception
- Patient refusal
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01629498
| Contact: Zhongxing Liao, MD | 713-563-2300 |
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Zhongxing Liao, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01629498 History of Changes |
| Other Study ID Numbers: | 2011-1058 NCI-2012-01224 5P01CA021239-32 2U19CA021239-35 |
| Study First Received: | June 25, 2012 |
| Last Updated: | July 22, 2016 |
| Health Authority: | United States: Food and Drug Administration United States: Federal Government |
Keywords provided by M.D. Anderson Cancer Center:
|
Lung cancer Non-small cell lung cancer NSCLC Image-guided intensity-modulated scanning beam proton therapy IMPT Simultaneous integrated boost |
SIB Gross tumor volume GTV Chemotherapy Questionnaire Survey |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
ClinicalTrials.gov processed this record on September 26, 2016