Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.

NCT01933568 | Completed Phase 1

• 1 other identifier: N12HYB
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent chemotherapy. It is hypothesized that this will lead to an increase of local control and overall survival

Conditions

Inoperable Locally Advanced Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The mean-lung dose that is associated with a 15% probability of dose limiting toxicity, defined according to the CTCAE v4; radiation pneumonitis ≥ grade 3 and radiation induced dyspnea ≥ grade 3.

  2 yrs

Study Arms (1)

Radiation

EXPERIMENTAL

combined CFRT and SABR with concurrent cisplatin

Radiation: SABR; Drug: Cisplatin

Interventions

SABR RADIATION

combined CFRT and SABR with concurrent cisplatin

Radiation

Cisplatin DRUG

combined CFRT and SABR with concurrent cisplatin

Radiation

Eligibility Criteria

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

You may not qualify if:

• Weight loss \< 10% in the last three months
• WHO-performance status ≤ 2
• Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine
• FEV1 and DLCO \> 40 % of the age-adjusted normal value
• Minimum required laboratory data bone marrow reserve and hepatic- and renal function
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Before patient registration, written informed consent must be given according to GCP and national regulations
• Patients with central tumors \< 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.
• Patients that receive sequential chemoradiotherapy or radiotherapy only.
• Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03)
• Patients with Pancoast tumors
• Prior radiotherapy treatment to the thorax
• Any contraindications to the administration of thoracic radiotherapy
• Pregnant women

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

The Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Related Publications (1)

• Peulen H, Franssen G, Belderbos J, van der Bijl E, Tijhuis A, Rossi M, Sonke JJ, Damen E. SBRT combined with concurrent chemoradiation in stage III NSCLC: Feasibility study of the phase I Hybrid trial. Radiother Oncol. 2020 Jan;142:224-229. doi: 10.1016/j.radonc.2019.07.015. Epub 2019 Aug 17.

  PMID: 31431387 DERIVED

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Heike Peulen, MD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 2, 2013
• Study Start: February 28, 2013
• Primary Completion: November 11, 2018
• Study Completion: November 11, 2018
• Last Updated: June 27, 2019

Record last verified: 2019-06

Locations

NL (1)