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

Esophageal Cancer Clinical Trial

— RESPECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836913
• Other study ID #: RESPECT
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: March 22, 2016
• Start date: May 2009
• Est. completion date: April 2014

Study information

• Verified date: March 2016
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2014
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Locations

Country	Name	City	State
Netherlands	RISO	Deventer	Overijssel
Netherlands	Medisch spectrum twente	Enschede	Overijssel
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. Review. — View Citation

Muijs CT, Pruim J, Beukema JC, Berveling MJ, Plukker JT, Langendijk JA. Oesophageal tumour progression between the diagnostic ¹8F-FDG-PET and the ¹8F-FDG-PET for radiotherapy treatment planning. Radiother Oncol. 2013 Mar;106(3):283-7. doi: 10.1016/j.radon — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	18 months	No
Secondary	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	6 months	No
Secondary	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	6 months	No
Secondary	Percentage of patients who develop distant metastases after treatment	Percentage of patients who develop distant metastases after treatment	18 months	No
Secondary	Cost-effectivity analyses	The costs of radiotherapy planning and treatment (surgical and/or chemoradiation), complications and recurrence-related treatment or the prevention thereof.	24 months	No