Photon Versus Particle Therapy for Recurrent Lung Cancer; a Planning Study Based on a Reference Dataset of Patients.

NCT02029222 | Completed

• 1 other identifier: ROCOCO
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with lung cancer may develop a second primary tumor or recurrent disease after previous radiotherapy. Surgical salvage therapy is the mainstay of therapeutic options. However, in case of irresectable disease, re-irradiation should be considered. Also in the postoperative setting, re-irradiation is considered after surgical salvage in case of features in the pathology specimen indicating a high risk for subsequent recurrence. However after re-irradiation, there is a high risk of 43% grade 3 (late) toxicity at 5 years (including possible fatal complications) and a relatively low chance of locoregional control of 50% at 5 years. One out of three patients survives re-irradiation without recurrence and severe complications. Improvements in both the risk of radiation-induced complications and the oncological outcome are thus warranted. Compared to conventional radiotherapy with photons (CRT), particle therapy (PT) has the potential to inflict maximum damage on tumors with minimum collateral damage to neighboring healthy tissue. Given that the cost of particle therapy (PT) is considerably higher than that of conventional radiotherapy (RT) with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages. Thus, clear evidence of the situations in which PT outperforms conventional photon treatment is needed. Publications on this topic are rare. The only recent publication has analyzed the results of 37 NSCLC patients of whom 9 were re-irradiated with at least 50 Gy using helical tomotherapy \[Kruser in press\]. We propose an in silico trial to investigate to what extend proton and 12C-ion therapy decrease the amount of irradiated normal tissue in lung cancer patients treated with radiotherapy after an initial radiotherapy treatment.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (5)

• The amount of irradiated normal tissue: lung

  \- lung: V30, V20, V13, V5, mean lung dose

  Up to ten months (planning time)

• The amount of irradiated normal tissue: Spinal cord

  Spinal cord: Dmax

  Up to ten months

• The amount of irradiated normal tissue: esophagus

  Esophagus: Dmax, mean dose (MD), V55, V35

  Up to ten months

• The amount of irradiated normal tissue: Heart

  Heart: Total dose (TD), V65, V45, V40, V30, V20, V10, MD

  Up to ten months

• The amount of irradiated normal tissue: Integral dose

  Integral dose

  Up to ten months

Secondary Outcomes (1)

• Risk of side effects in the irradiated normal tissue

  Up to ten months

Other Outcomes (1)

• Possibilities of hypofractionation

  Up to ten months

Study Arms (1)

25 NSCLC patients

25 NSCLC patients who received curative radiotherapy. Re-irradiation can either be indicated for primary or secondary cancers in the lung. All patients referred for primary radiotherapy or chemoradiation after curative radiation therapy more or equal to one year ago with overlapping CTV will be included. The organs at risk of the primary tumor are the same organs at risk at the secondary treatment.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

25 patients with SCLC

You may qualify if:

• Re-irradiation patients for relapsed or second cancers in the left or the right lung
• Received respitory gated CT (4DCT) and PET (4DPET) scans.
• The primary treatment was radiotherapy with a curative intent
• The organs at risk of the primary tumor treatment are the same organs at risk at the secondary treatment
• years or older

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• University of Pennsylvania: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Maastricht Radiation Oncology

Maastricht, 6229 ET, Netherlands

Location

Study Officials

• Philippe Lambin, MD, PhD

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 7, 2014
• Study Start: December 1, 2013
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

NL (1)