SBRT Dose Escalation for Reirradiation of Inoperable Lung Lesions

NCT04455438 | Unknown

• 1 other identifier: 2525
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective phase I study to evaluate the maximum tolerated dose (MTD) of SBRT for thoracic re-irradiation. Dose limiting toxicity will be pneumonitis ≥ G3. The potential advantage of the dose escalation planned in this study is the delivery of an ablative dose to radically treat patients with inoperable local relapse, without unacceptable toxicity.

Conditions

Non Small Cell Lung Cancer; Lung Metastases

Outcome Measures

Primary Outcomes (1)

• MTD

  maximal tolerated dose (MTD) of SBRT for thoracic re-irradiation

  5 years

Secondary Outcomes (4)

• Other toxicities

  5 years

• Overall survival

  5 years

• Local control

  5 years

• PFS

  5 years

Study Arms (3)

SBRT Level 1

EXPERIMENTAL

The starting dose level will be SBRT 30 Gy in 5 fractions (level 1 or L1).

Radiation: SBRT dose escalation

SBRT Level 2

EXPERIMENTAL

If the starting dose is tolerated in the first 5 patients, the next dose will be SBRT 40 Gy in 5 fractions (level 2 or L2)

Radiation: SBRT dose escalation

SBRT Level 3

EXPERIMENTAL

If the second dose is tolerated in the next 5 patients, the next dose will be SBRT 50 Gy in 5 fractions (level 3 or L3)

Radiation: SBRT dose escalation

Interventions

SBRT dose escalation RADIATION

Re-Stereotactic Body Radiation Therapy (SBRT) with increasing dose levels, from 30 Gy in 5 fractions to 50 Gy in 5 fractions.

SBRT Level 1; SBRT Level 2; SBRT Level 3

Eligibility Criteria

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

You may qualify if:

• Inoperable primary non-small cell lung cancer or other metastatic primaries with lung metastases, already treated with radical dose RT;
• Peripheral lesion (\> 2 cm from trachea-bronchial tree);
• Inoperable local recurrence (defined as a tumor recurrence overlapping the 50% isodose field) confirmed by documented radiographic findings and/or pathological biopsies within the thoracic area;
• Patients had previously received curative intent RT of more than 50 Gy for conventionally fractionated RT or a biologically equivalent dose of more than 75 Gy for SBRT;
• No active distant metastasis or controlled distant metastasis at the time of re-irradiation

You may not qualify if:

• Central or ultra-central lesion(s);
• Incapability of understanding and signing informed consent.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Davide Franceschini, MD

CONTACT

0039 028224 7428; davide.franceschini@gmail.com

Federico Fornasier, M.Sc

CONTACT

0039 028224 7026; federico.fornasier@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed to determine the Maximum Tolerated Dose (MTD) that could be safely delivered in the lung reirradiation setting. The MTD was defined as the highest dose level in which a proportion of 1 out of 5 or fewer patients experienced DLT. Due to the late onset nature of DLT, in order to allow for continuous accrual without sacrificing patient safety or the accuracy of identifying the MTD, the Time-To-Event Bayesian Optimal Interval (TITE-BOIN) design will be used.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: May 28, 2020
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)