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Esophageal CancerRESPECTNCT01836913

Value of PET-CT in Radiation Treatment Planning for Patients With Esophageal Cancer

An observational study of Esophageal Cancer, run by University Medical Center Groningen at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The RESPECT study is intended to prospectively assess the impact of PET/CT on the delineation of target volumes and to estimate the proportion of recurrences that could possibly be prevented by the use of PET/CT-based target volume, instead of CT-based. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
How many people
90 participants
Where
3 sitesNetherlands
Study dates
May 2009to Apr 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with histologically proven esophageal carcinoma who are planned for curative high dose radiotherapy with or without chemotherapy, with or without surgery.

Inclusion Criteria:- Histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus or GEJ

  • Locally curable disease without distant metastases (M1b is excluded) (TNM clinical classification UICC 7th edition)
  • Planned for high dose radiotherapy with or without chemotherapy with or without surgery
  • Age ≥ 18 years;
  • WHO performance status 0-2
  • informed consent must be given according to ICH/EU GCP, and national/local regulations

Exclusion Criteria:- previous or concurrent malignancies (except basal cell carcinoma of the skin or in situ carcinoma of the cervix or superficial bladder cancer (pTa)) in the past five years

  • Previous treatment
  • Evidence of serious active infections
  • any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • RISO

    Deventer, Overijssel

  • Medisch spectrum twente

    Enschede, Overijssel

  • University Medical Center Groningen

    Groningen, Provincie Groningen, 9700RB

Other trials in Netherlands

About this study

The RESPECT study is intended to prospectively assess the impact of PET/CT on the delineation of target volumes and to estimate the proportion of recurrences that could possibly be prevented by the use of PET/CT-based target volume, instead of CT-based. Patients will recieve radiotherapy using CT-based planning, but a PET/CT-based treatment plan will also be made. CT-based and PET/CT-based target volumes will be compared after treatment has been completed. If a locoregional recurrence takes place, the localisation will be compared to the CT-based and PET/CT based clinical target volumes (CTVs). If the local recurrence is located outside the CT-CTV but inside the PET/CT-CTV, the recurrence could possibly have been prevented with PET/CT-based radiotherapy.

Read the detailed description

This is a prospective cohort study testing the hypothesis that in a proportion of patients, locoregional recurrence, observed at 6, 12 or 18 months after treatment, can be prevented if PET/CT-based treatment planning was used instead of CT-based treatment planning alone.

Patients eligible for the study will undergo definitive radiotherapy with or without concomitant chemotherapy with planning-CT based target volumes, either or not followed by surgery.

A planning-PET/CT will be made for research purposes only, and will be blinded for the treating physicians. This planning-PET/CT will not be used for actual treatment planning.

In case of neoadjuvant chemoradiation the response on this therapy will be analysed at pathologic evaluation of the esophageal specimen.

Routine follow up will be carried out every 6 months, using CT. In case of no locoregional recurrence and/or metastases, patients will be followed up to 18 months for study evaluation.

In case of distant metastases, patients will be censored if locoregional recurrence is excluded. When indicated, palliative treatment will be given.

In case of (suspicion of) locoregional recurrence, PET/CT-based recurrence analysis should be carried out with comparison and co-registration of CT-based and PET/CT-based target volumes.

Keywords
PET/CT, Esophageal cancer, Radiotherapy
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01836913
Study groupRoleWhat they receive
Radiotherapy for esophageal cancerPatients with histology proven esophageal cancer who are planned for high dose radiotherapy with or without chemotherapy with or without surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preventable locoregional recurrence by the use of PET/CT-based treatment planning, instead of CT-based

    Proportion of patients with a locoregional recurrence, observed at 6, 12 or 18 months after treatment, can the recurrence be considered as possibly preventable if PET/CT-based treatment planning was used instead of CT-based treatment planning alone (located outside the CT-based CTV, but inside the PET/CT-based CTV)

    Measured: 18 months

Secondary outcomes (4)

  1. Differences in GTV, CTV and PTV for CT-based and PET/CT-based treatment planning

    Differences in GTV (gross target volume), CTV and PTV (planning target volume) for CT-based and PET/CT-based treatment planning

    Measured: 6 months

  2. Differences in dose distribution to OAR for CT and PET/CT-based treatment plans

    Dose distribution in critical organs, including lung (mean lung dose, V20), heart (V30) and esophagus and calculation of NTCP values (Normal Tissue Complication Probability) comparing 3D-CRT and IMRT with and without PET/CT-based treatment planning

    Measured: 6 months

  3. Percentage of patients who develop distant metastases after treatment

    Percentage of patients who develop distant metastases after treatment

    Measured: 18 months

  4. Cost-effectivity analyses

    The costs of radiotherapy planning and treatment (surgical and/or chemoradiation), complications and recurrence-related treatment or the prevention thereof.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2013 (estimated)
  2. Study startMay 2009
  3. Primary completionApr 2012
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01836913
Sponsor's protocol ID
RESPECT
Acronym
RESPECT
Status last verified
Mar 2016
First submitted
17 Apr 2013
Last updated
23 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • Muijs CT, Beukema JC, Pruim J, Mul VE, Groen H, Plukker JT, Langendijk JA. A systematic review on the role of FDG-PET/CT in tumour delineation and radiotherapy planning in patients with esophageal cancer. Radiother Oncol. 2010 Nov;97(2):165-71. doi: 10.1016/j.radonc.2010.04.024. Epub 2010 Jun 10.

    PubMed 20541273

  • Muijs CT, Pruim J, Beukema JC, Berveling MJ, Plukker JT, Langendijk JA. Oesophageal tumour progression between the diagnostic (1)(8)F-FDG-PET and the (1)(8)F-FDG-PET for radiotherapy treatment planning. Radiother Oncol. 2013 Mar;106(3):283-7. doi: 10.1016/j.radonc.2012.10.015. Epub 2012 Nov 27.

    PubMed 23199654

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Cancer, run by University Medical Center Groningen at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preventable locoregional recurrence by the use of PET/CT-based treatment planning, instead of CT-based (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01836913, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.

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