NCT04001543Active, not recruiting
Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Cancer
Double-blind Multicenter Phase III Trial Evaluating the Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC)
Source: ClinicalTrials.gov · Last updated 12 Feb 2025
Brief summary (registry, in English)
The investigators designed a prospective randomized double-blind trial to determine if the oral immunomodulating formula could improve the disease-free survival rate in high-risk locally-advanced head and neck Squamous Cell Carcinoma patients treated with Chemoradiotherapy.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 6 Jun 2019
- Start date
- 14 Mar 2019
- Primary completion date
- 2 Mar 2021
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Diseases
- Head and neck cancer
- NCT number
- NCT04001543
What you commit to
- Study type: Interventional
- Participants enrolled: 27
- From 14 Mar 2019 to the primary completion date, 2 Mar 2021
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other immunomodulating diets in the last month before inclusion
Other illness
- Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers
- History of hypersensitivity and/or allergy to any component of Oral Impact ®
- Patients with history of malignancies who are not disease-free for more than 5 years.
Other
- Sepsis at baseline
- Distant metastasis
- Parenteral nutrition at baseline
Who the study is looking for
- Surgically resected primary squamous cell carcinomas (HNSCC) of the hypopharynx, oropharynx, larynx and oral cavity with pathological stage pT1-2 pN+ (pathological stage 1 ou 2 with node) or pT3-4 any pN (pathological stage 3 ou 4 with or without node) (UICC 7th edition, 2010),
- Postoperative concomitant CRT based on radiotherapy and on cisplatinum, 3 cycles, 100mg/m² by cycle,
- Patients who undergone macroscopically complete resection,
- High-risk characteristics patients with one or more following criteria: such as invasion of two or more regional lymph nodes, extracapsular extension of nodal disease or microscopically-involved mucosal margins of resection, perineural involvement, vascular tumor embolism,
- WHO (World Health Organization) performance status 0, 1 or 2,
- Age: 18 years old up to 75 years old including,
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Institut du Cancer de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.