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


N/A
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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)

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Johannes A Langendijk, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Center Groningen, Department of Radiation Oncology

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

RESPECT

NCT ID:

NCT01836913

Start Date:

May 2009

Completion Date:

December 2013

Related Keywords:

  • Esophageal Cancer
  • PET/CT
  • Esophageal cancer
  • Radiotherapy
  • Esophageal Diseases
  • Esophageal Neoplasms

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