NCT03053661

Brief Summary

The IRECT trial is a non-interventional, prospective clinical trial using modern immune monitoring techniques over the course of the standard of care for HNSCC. The dynamics of host/tumor immune interactions during the conventional standard treatment will be analyzed to find the most promising target antigen and to develop a strategy how and when specific immunotherapy should be added to the current treatment schedule. The results from this trial will help to understand how state of the art treatment can be complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to improve the outcome of head and neck cancer patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

7 years

First QC Date

February 12, 2017

Last Update Submit

October 10, 2018

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Squamous Cell Carcinomacancer-specific immunitycancer immunologycancer-testis antigenshuman papilloma virusimmune modulatory cells

Outcome Measures

Primary Outcomes (3)

  • prevalence of spontaneous tumor-specific immunity at baseline

    baseline

  • dynamics of tumor-specific immunity and immune modulatory cells during conventional treatment

    7-12 weeks (treatment phase)

  • dynamics of tumor-specific immunity and immune modulatory cells during follow up

    12 months after end of treatment

Secondary Outcomes (2)

  • overall survival at 3 years

    baseline - 3 years

  • progression free survival at 3 years

    baseline - 3 years

Study Arms (2)

primary surgery + adj. C)RT

treatment naive patients to be treated by conventional primary surgery followed by adjuvant (chemo-)radiotherapy with curative intent

primary chemoradiation

treatment naive patients to be treated by conventional primary chemoradiotherapy with curative intent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stage III-IVa/b treatment-naive head and neck squamous cell carcinoma patients

You may qualify if:

  • newly diagnosed patients with stage III-IVa/b head and neck squamous cell carcinoma
  • fit for treatment with curative intent
  • conventional primary treatment
  • primary surgical treatment
  • primary radiotherapeutic treatment
  • informed consent
  • \>18 years of age
  • sufficient contraception

You may not qualify if:

  • distant metastasis at baseline
  • severe concomitant disease compromising curative treatment
  • previously diagnosed other malignant diseases
  • active immunosuppressive therapy
  • known immune defect
  • pregnancy
  • anemia requiring treatment at study entry (\<9g/dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • von Witzleben A, Fehn A, Grages A, Ezic J, Jeske SS, Puntigam LK, Brunner C, Kraus JM, Kestler HA, Doescher J, Brand M, Theodoraki MN, Ottensmeier CH, Hoffmann TK, Schuler PJ, Laban S. Prospective longitudinal study of immune checkpoint molecule (ICM) expression in immune cell subsets during curative conventional therapy of head and neck squamous cell carcinoma (HNSCC). Int J Cancer. 2021 Apr 15;148(8):2023-2035. doi: 10.1002/ijc.33446. Epub 2020 Dec 30.

    PMID: 33336372DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, peripheral blood mononuclear cells, tumor tissue (fresh frozen), formalin fixed paraffin embedded tumor tissue

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head & Neck Cancer Lead, Interdisciplinary Oncologic Outpatient Unit

Study Record Dates

First Submitted

February 12, 2017

First Posted

February 15, 2017

Study Start

August 1, 2013

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share