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Completed

NCT Number: NCT01836913

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

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RISO, Deventer, Overijssel, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Acronym: RESPECT

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Apr 22, 2013
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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