The main objective of this pilot study is to evaluate the effect of motion mitigation with BiPAP or CPAP on tumor motion during the course of radiotherapy in patients with intra-thoracic tumors.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the effect of CPAP or BiPAP on tumor motion (tumor
amplitude expressed in millimeters) during the course of radiotherapy.
Secondary outcome
Phase 1: Feasibility of the use of CPAP and BiPAP in terms of the time a
patient can use CPAP or BiPAP. We consider it feasible in case patients can
wear the mask more than 10 minutes.
Phase 2: Change in lung volumes (based on CT images); tidal volumes and
breathing frequency with the use of CPAP or BiPAP in healthy controls and
patients with intra-thoracic tumors. Feasibility of CPAP or BiPAP use for
patients with intra-thoracic tumors. To evaluate this, the duration of wearing
the mask will be monitored. We consider it feasible in case patients can wear
the mask more than 10 minutes. Reproducibility of controlling lung volumes
during the course of radiotherapy by evaluation of the base-line shift. The
influence of the anticipated reduction in target volume and the consequences
for the dose distributions (to the target and to the organs at risk) for both
photon and proton based radiotherapy plans (with and without mechanical
ventilation).
Background summary
Compared to photon radiotherapy, radiotherapy using protons may reduce toxicity
in patients with intra-thoracic tumors. However, breathing motion of
intra-thoracic tumors is a concern for proton therapy as tumor motion may
increase dose uncertainty substantially. Although sophisticated radiotherapy
planning techniques have been developed to take these uncertainties into
account, motion mitigation may still be beneficial, especially in target
volumes that show large tumor motion. With the use of a ventilator that is able
to regulate and modulate the breathing pattern of the patient, this reduction
in tumor motion may be achieved. In turn, this may result in a more robust
proton treatment plan.
Study objective
The main objective of this pilot study is to evaluate the effect of motion
mitigation with BiPAP or CPAP on tumor motion during the course of
radiotherapy in patients with intra-thoracic tumors.
Study design
The study will follow a 2-step approach. First we will investigate the
feasibility of short-term use of CPAP and BiPAP and its effects on lung
volumes, tidal volumes and breathing frequency in patients with cancer who are
planned for thoracic radiotherapy. By doing so we are able to select the best
setting of BiPAP/CPAP with which minimal tumor motion is expected. In a second
phase we will investigate this particular setting of BiPAP or CPAP in the
setting of radiotherapy: weekly repeated CTs will be acquired during the course
of radiotherapy to evaluate the effect of BiPAP and CPAP on tumor motion and
its consequential effects on target coverage of the radiotherapy treatment
plan.
Phase 1: initially 10 patients (5 with lung cancer and 5 patients with
esophageal cancer or malignant lymphoma) will be included to refine the
ventilatory assist protocol prior to radiotherapy. Changes in lung volumes
compared to spontaneous breathing will be measured using electrical impedance
tomography (EIT). Furthermore, we will monitor the participant for comfort and
safety.
Phase 2: the optimal assists mode (CPAP or BiPAP) will be incorporated in the
routine preparations for radiotherapy for intra-thoracic tumors. Patients will
be treated according to standard clinical practice. Study participants will
undergo extra repeated 4D-CTs (without contrast agent, while on BiPAP or CPAP
using optimal assist mode) once every week during treatment.
Study burden and risks
Participation in this study does not involve any additional risk to healthy
subjects nor patients, besides the risk incurred by additional CT-scans for the
patients. CPAP or BIPAP for short periods is not associated with risks.
Patients will undergo weekly repeated CTs during the course of radiotherapy; in
total this consists of a maximum of 11 extra CTs. The additional effective dose
of these extra images is low (i.e., 11 x 25-30mSv for the 4DCTs, resulting in a
total extra dose < 330mSv) compared to the radiation dose of the treatment (20
- 60Gy). The risks are therefore negligible and the burden is low. No extra
hospital visits are necessary as the appointments for the repeated 4D-CTs are
scheduled together with the regular visits during the course of radiotherapy.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
Intra-thoracic malignancy (locoregionally advanced stage lung cancer,
esophageal cancer or malignant lymphoma) that wil be treated with curative
intent with radiotherapy. Informed consent needs te bo obtained. Age: 18 years
or older.
Exclusion criteria
• Facial deformations so that facial mask are impossible to fit
• Noncompliance with any of the inclusion criteria.
• Planned for radiotherapy with fraction dose >=3 Gy.
• Severe heart failure (LVEF<30%)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71871.042.19 |