Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay

NCT02797405 | Terminated

• 2 other identifiers: ET15-0032015-A00931-48
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 7

Brief Summary

THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the predictive value of the A \& MS bioassays on tumor control by radiotherapy.

Conditions

Sarcoma; Rectal Carcinoma; Esophagus Cancer

Keywords

radiation therapy; radiosensitivity; in vitro diagnostic medical devices; Adverse Event post radiotherapy

Outcome Measures

Primary Outcomes (2)

• Calibration of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples

  The calibration stage will be performed using data from the first 40 patients enrolled. All the potential correlations between the clinical and radiobiological parameters will be tested. The links between clinical tumor response parameters and radiobiological parameters derived from MS/A bioassays using tumor samples.

  2.5 years (after 100 patients enrolled )

• Validation of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples

  The validation stage will be performed using data from the remaining 60 patients enrolled. This stage will assess whether or not the prediction of tumor response derived from the A/MS bioassays fits with the observed tumor response after RT.

  2.5 years (after 100 patients enrolled )

Secondary Outcomes (1)

• Validation of the correlation between the healthy tissue response (i.e. AE reported as per CTCAE v4) and the results of MS/A bioassays using skin biopsies

  2.5 years (after 100 patients enrolled )

Study Arms (1)

Standard treatment

OTHER

The patients will receive standard treatment according to international recommendations depending on their type of cancer.

Radiation: Standard treatment

Interventions

Standard treatment RADIATION

Sarcoma patients will undergo radiotherapy followed by surgery Rectum cancer patients will undergo radio-chemotherapy followed by surgery Esophagus cancer patients will undergo radio-chemotherapy followed by surgery

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• I1. Patients (male or female) ≥ 18 years of age. I2. Adult patients with a suspected, non-treated, non-metastatic retroperitoneal or limb soft tissue sarcoma, esophagus cancer or rectum cancer to be treated by pre-operative radiotherapy or radio-chemotherapy I3. At least one measurable lesion as per RECIST 1.1 I4. Documented negative serology tests (HVB, HIV, HVC) I5. PS ECOG 0 to 1 I6. Patient able and willing to provide informed consent. I7. Ability to understand and willingness for follow-up visits. I8. Covered by a medical insurance.

You may not qualify if:

• E1. Contra-indication to radiotherapy E2. Contra-indication to skin biopsy

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (7)

Centre Francois Baclesse

Caen, France

Location

Infirmerie Protestante

Caluire-et-Cuire, 69641, France

Location

Centre Georges-François Leclerc

Dijon, 21079, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

ICL - Institut de Cancérologie de la Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Hopital Nord Ouest Villefranche Sur Saone

Villefranche-sur-Saône, France

Location

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MeSH Terms

Conditions

Sarcoma; Rectal Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Officials

• Marie-Pierre SUNYACH, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 13, 2016
• Study Start: October 1, 2016
• Primary Completion: August 13, 2019
• Study Completion: March 13, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)