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

Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Esophageal Cancer

Phase: N/A

Status: Active, not recruiting

Sponsored by: University Medical Center Groningen

Official(s) and/or principal investigator(s):
Johannes A Langendijk, PhD, MD, Principal Investigator, Affiliation: University Medical Center Groningen, Department of Radiation Oncology
John Th Plukker, PhD, MD, Principal Investigator, Affiliation: University Medical Center Groningen, Department of Surgical Oncology

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Preventable locoregional recurrence by the use of PET/CT-based treatment planning, instead of CT-based

Secondary outcome:

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

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

Percentage of patients who develop distant metastases after treatment

Cost-effectivity analyses

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University Medical Center Groningen, Groningen 9700RB, Netherlands

RISO, Deventer, Overijssel, Netherlands

Medisch spectrum twente, Enschede, Overijssel, Netherlands

Additional Information

Related 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. Review.

Starting date: May 2009
Last updated: April 17, 2013

Page last updated: August 23, 2015

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