Clinical trial NCT01836913: Value of PET-CT in Radiation Treatment Planning for Patients With Esophageal Cancer
Official title: Value of PET-CT in Radiation Treatment Planning for Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: PET/CT
Esophageal cancer
Radiotherapy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2013-04-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically proven esophageal carcinoma who are planned for curative high dose radiotherapy with or without chemotherapy, with or without surgery.

Brief 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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Preventable locoregional recurrence by the use of PET/CT-based treatment planning, instead of CT-based
timeFrame: 18 months
Secondary outcomes:
measure: Differences in GTV, CTV and PTV for CT-based and PET/CT-based treatment planning
timeFrame: 6 months
measure: Differences in dose distribution to OAR for CT and PET/CT-based treatment plans
timeFrame: 6 months
measure: Percentage of patients who develop distant metastases after treatment
timeFrame: 18 months
measure: Cost-effectivity analyses
timeFrame: 24 months
Other outcomes:
Locations:
city: Deventer
country: Netherlands
facility: RISO
state: Overijssel
city: Enschede
country: Netherlands
facility: Medisch spectrum twente
state: Overijssel
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen, Department of Radiation Oncology
name: Johannes A Langendijk, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen, Department of Surgical Oncology
name: John Th Plukker, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.