Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01629498
First received: June 25, 2012
Last updated: September 8, 2014
Last verified: September 2014
  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)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: 55
Study Start Date: September 2012
Estimated Primary Completion Date: September 2016 (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.

Phase II Starting Dose: Maximum tolerated dose (MTD) from Phase I.

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.

Phase II Starting Dose: Maximum tolerated dose (MTD) from Phase I.

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.

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.

Other Names:
  • Intensity-modulated Radiation Therapy
  • IMRT
  • Simultaneous integrated boost
  • SIB

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 with or without using gating or breath-holding
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629498

Contacts
Contact: Zhongxing Liao, MD 713-563-2300

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Zhongxing Liao, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01629498     History of Changes
Other Study ID Numbers: 2011-1058, 5P01CA021239-32, NCI-2012-01224
Study First Received: June 25, 2012
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014