Intensity-Modulated Scanning Beam Proton Therapy (IMPT) With Simultaneous Integrated Boost (SIB)

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Lung Cancer	Radiation: IMPT + SIB + Chemotherapy; Behavioral: Questionnaire; Radiation: IMRT + SIB + Chemotherapy	Phase 1; Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	39 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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)
Actual Study Start Date :	September 17, 2012
Estimated Primary Completion Date :	September 2019
Estimated Study Completion Date :	September 2019

Arms and Interventions

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Arm	Intervention/treatment
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: Intensity-modulated scanning beam proton therapy; IMPT; Simultaneous integrated boost; SIB 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: Intensity-modulated Radiation Therapy; IMRT; Simultaneous integrated boost; SIB

Outcome Measures

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Primary Outcome Measures :

1. Maximum Tolerated Dose (MTD) of Image-Guided Intensity-Modulated Photon (IMRT) and Proton Therapy (IMPT) [ Time Frame: 90 days from start of radiation therapy ]
   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.

Secondary Outcome Measures :

1. Progression-Free Survival [ Time Frame: 1 year ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Pathologically proven diagnosis of unresected stage II-IIIB, or recurrent after surgical resection non-small cell lung cancer
2. Suitability for concurrent chemoradiation therapy per treating physician's assessment
3. Karnofsky Performance Status (KPS) score >/=70, weight loss <15% in the 3 months before diagnosis
4. Prior receipt of induction chemotherapy followed by referral for concurrent chemoradiation is allowed
5. Adequate lung function indicated by forced expiratory volume at 1 second (FEV)1 >/=1 L is required
6. The primary tumor and/or regional lymph nodes must be evaluable radiographically
7. 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).
8. Age >/= 18 years
9. No prior radiation to the mediastinal structures
10. 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
11. 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:

1. Prior radiotherapy to any anatomic regions that would result in overlap of radiation dose distribution to critical structures (esophagus, heart, spinal cord, brachial plexus)
2. T4 tumor with direct invasion of esophagus, spinal cord, major blood vessel, or heart
3. GTV motion >5 mm on four-dimensional computed tomography (4D CT) scanning with or without respiratory management using gating or breath-holding
4. Pregnancy (because the treatment involves unforeseeable risks to the participant and to the embryo or fetus)
5. Patients of childbearing potential must practice appropriate contraception
6. Patient refusal

Contacts and Locations

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Locations

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Massachusetts General Hospital

Investigators

Principal Investigator:	Zhongxing Liao, MD	M.D. Anderson Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01629498 History of Changes
Other Study ID Numbers:	2011-1058; NCI-2012-01224 ( Registry Identifier: NCI CTRP ); 5P01CA021239-32 ( U.S. NIH Grant/Contract ); 2U19CA021239-35 ( U.S. NIH Grant/Contract )
First Posted:	June 27, 2012
Last Update Posted:	December 5, 2017
Last Verified:	December 2017

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; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site	Neoplasms; Lung Diseases; Respiratory Tract Diseases