A Phase I/II Trial of Stereotactic Body Radiation Therapy

NCT00591838 | Completed Phase 1 Results DMC FDA Device

• 1 other identifier: 06-0691 / 201012832
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use SBRT in patients with early stage lung cancer and find out what effects (good and bad) SBRT has on their cancer. This research is being done because SBRT has not been used very often in patients with early stage lung cancer or in patients with other serious health problems. In addition, this study also will gather information about patient's health and hospitalization history. This information will be used to find out if there are any factors that can help predict recovery or outcome of patients with lung cancer.

Conditions

Inoperable Stage I/II Non-small Cell Lung Cancer

Keywords

SBRT

Outcome Measures

Primary Outcomes (4)

• Phase I Portion Only: Determine the Maximum Tolerated Dose of SBRT

  The phase 1 portion had a "5+3" strategy with four escalating dose levels, only one of which was open for accrual at any time. Five patients were accrued to each dose level, and once closed, the next dose level could not be opened until the preceding dose was deemed acceptable. With a minimum of 90 days from the start of RT, if there were no acute grade 3 or 4 non-hematologic toxicities in the five patients, the current dose was deemed acceptable. If one such toxicity was observed, an additional 3 patients were recruited and followed for a minimum of 90 days. If 2 or more such toxicities were observed, the current dose was determined as dose limiting, and the previous dose level was used for the phase 2 portion.

  Completion of phase I enrollment (Phase I enrollment took 4 years)

• Phase I Portion Only: Number of Participants With Acute Treatment Related Grade 3-5 Toxicity

  * CTCAE version 3.0 will be used to grade toxicity * Acute toxicity are adverse events that occur from start of treatment through 90 days

  Up to 90 days

• Phase I Portion Only: Number of Participants With Late Treatment Related Grade 3-5 Toxicity

  * CTCAE version 3.0 will be used to grade toxicity * Late toxicity are adverse events that occur from Day 91 through 2 years

  91 days to 2 years

• Phase II Portion Only: Local Control Rate

  Local control rate is defined as the absence of isolated failure (progression) within the primary tumor and involved lobe

  2 years

Secondary Outcomes (4)

• Phase II Only: Regional Nodal Recurrence Rate

  2 years

• Phase II Only: Disseminated Recurrence Rate

  2 years

• Phase II Only: Disease-free Survival Rate

  2 years

• Phase II Only: Overall Survival Rate

  2 years

Study Arms (5)

Phase I Dose Level A: SBRT 9Gy x 5 fractions

EXPERIMENTAL

-Stereotactic body radiation therapy (SBRT) dose of 9Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Phase I Dose Level B: SBRT 10Gy x 5 fractions

EXPERIMENTAL

-Stereotactic body radiation therapy (SBRT) dose of 10Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Phase I Dose Level C: SBRT 11Gy x 5 fractions

EXPERIMENTAL

-Stereotactic body radiation therapy (SBRT) dose of 11Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Phase I Dose Level D: SBRT 12Gy x 5 fractions

EXPERIMENTAL

-Stereotactic body radiation therapy (SBRT) dose of 12Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Phase II: SBRT 11Gy x 5 fractions

EXPERIMENTAL

-Stereotactic body radiation therapy (SBRT) dose of 11Gy for 5 fractions which is 5 total radiation treatments given over the course of about a week. The phase II dose was determined during the phase I portion of the study.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

Phase I Dose Level A: SBRT 9Gy x 5 fractions; Phase I Dose Level B: SBRT 10Gy x 5 fractions; Phase I Dose Level C: SBRT 11Gy x 5 fractions; Phase I Dose Level D: SBRT 12Gy x 5 fractions; Phase II: SBRT 11Gy x 5 fractions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed non-small cell cancer by biopsy or cytology. Squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar carcinoma, or non-small cell carcinoma (not otherwise specified) are allowed.
• Staging studies must identify patient as AJCC Stage I or II based on only 1 of following combinations of TNM staging:
• T1, N0, M0
• T2 (\<=7cm), N0, M0
• T3 (\<=7cm), N0, M0
• Primary tumor must be arising in one of the following central chest locations:
• Within or touching the zone of the proximal bronchial tree (a volume 2cm in all directions around the proximal bronchial tree \[carina, R \& L main bronchi, R \& L upper lobe bronchi, intermedius bronchus, R middle lobe bronchus, lingular bronchus, R \& L lower lobe bronchi\])
• Adjacent to (within 5 mm) or invading the mediastinal pleura
• Adjacent to (within 5 mm) or invading the parietal pericardium
• To differentiate T3 lesions involving the mediastinal pleura from T4 lesions involving major vessels or organs, a chest MRI will be obtained. If any uncertainty remains, the patient will have four-dimensional CT scans (4DCT) in an effort to determine the degree of tumor motion. A freely mobile tumor during ventilation will be judged to be T3 disease.
• Patients with hilar or mediastinal lymph nodes \<=1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with \>1cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer.
• Primary tumor must be technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (potentially curative resection, PCR). However, patients must have underlying physiological medical problems prohibiting PCR (i.e., problems with general anesthesia, the operation, the post-op recovery period, or removal of adjacent functioning lung) or refuse surgery. Deeming a patient medically inoperable based on pulmonary function for surgical resection may include any of the following: baseline FEV1 \<40% predicted; post-operative predicted FEV1 \<30% predicted; severely reduced diffusion capacity; baseline hypoxemia and/or hypercapnia; exercise oxygen consumption \<50% predicted; severe pulmonary hypertension; diabetes with severe end organ damage; severe cerebral, cardiac, or peripheral vascular disease; or severe chronic heart disease. Any one of these problems will qualify a patient for this trial.
• Age \>=18.
• Zubrod performance status 0-2.
• Women of childbearing potential must use effective contraception.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available.

  PMID: 26104945 DERIVED

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Clifford Robinson, M.D.
• Organization: Washington University School of Medicine

clifford.robinson@wustl.edu

314-362-4633

Study Officials

• Clifford Robinson, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: January 11, 2008
• Study Start: September 21, 2006
• Primary Completion: June 12, 2018
• Study Completion: June 12, 2018
• Last Updated: July 30, 2019
• Results First Posted: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)