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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01836913
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : March 23, 2016
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Johannes A. Langendijk, University Medical Center Groningen

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.

Condition or disease
Esophageal Cancer

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.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Value of PET-CT in Radiation Treatment Planning for Patients With Esophageal Cancer
Study Start Date : May 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Radiotherapy for esophageal cancer
Patients with histology proven esophageal cancer who are planned for high dose radiotherapy with or without chemotherapy with or without surgery.



Primary Outcome Measures :
  1. Preventable locoregional recurrence by the use of PET/CT-based treatment planning, instead of CT-based [ Time Frame: 18 months ]
    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)


Secondary Outcome Measures :
  1. Differences in GTV, CTV and PTV for CT-based and PET/CT-based treatment planning [ Time Frame: 6 months ]
    Differences in GTV (gross target volume), CTV and PTV (planning target volume) for CT-based and PET/CT-based treatment planning

  2. Differences in dose distribution to OAR for CT and PET/CT-based treatment plans [ Time Frame: 6 months ]
    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

  3. Percentage of patients who develop distant metastases after treatment [ Time Frame: 18 months ]
    Percentage of patients who develop distant metastases after treatment

  4. Cost-effectivity analyses [ Time Frame: 24 months ]
    The costs of radiotherapy planning and treatment (surgical and/or chemoradiation), complications and recurrence-related treatment or the prevention thereof.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836913


Locations
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Netherlands
RISO
Deventer, Overijssel, Netherlands
Medisch spectrum twente
Enschede, Overijssel, Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Johannes A Langendijk, PhD, MD University Medical Center Groningen, Department of Radiation Oncology
Principal Investigator: John Th Plukker, PhD, MD University Medical Center Groningen, Department of Surgical Oncology

Publications of Results:
Other Publications:
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Responsible Party: Johannes A. Langendijk, M.D., Ph.D., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01836913    
Other Study ID Numbers: RESPECT
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Keywords provided by Johannes A. Langendijk, University Medical Center Groningen:
PET/CT
Esophageal cancer
Radiotherapy
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases