Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Tumor Stage 1 or 2, Nodes 0 (T1-T2 N0) Operable

Head and Neck Tumors Clinical Trial

— SentiMERORL  

Official title:

Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx T1-T2N0 Operable : Comparison of the Reference Strategy Based on a the Systematic Lymph Node Dissection Versus the Strategy Based on the Technique of Sentinel Lymph Node.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855723
• Other study ID #: UF 5023
• Secondary ID: 2007- AO1191-52
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: August 1, 2016
• Start date: April 2008
• Est. completion date: August 2015

Study information

• Verified date: July 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial Summary

Currently, patients with cancer of oral cavity or oropharynx T1-T2N0 classified, are treated surgically with systematic lymph node dissection while in 70%, there is no lymph node metastasis. The technique of identifying the sentinel node (GS) is validated for these tumors because the status of the sentinel node is predictive of the other nodes status in the neck. This helps to diagnose the presence of metastases without lymph node dissection and thus select patients requiring a treatment node. However, the oncological and functional results of a therapeutic strategy based on identifying the GS is unknown.

This open-label randomized multicenter clinical trial aims to compare the oncologic and functional outcome of two strategies : the current management versus the management based on the sentinel lymph node.

The hypothesis is based on a nodal control difference at 2 years in both arms not exceeding 10%. The medico-economic analysis will be conducted in two stages : a classic stage on 2 years with estimated incremental cost-effectiveness and incremental cost-utility, then a step with log term modeling.

A reduction in morbidity and treatment costs in the sentinel node arm are expected in this study.

Description:

This study schedules the screening visit (V0) and then 9 follow-up visits during 24 months.

At the screening, after verification of the eligibility criteria and signature of the informed consent form, the subject will be randomized in one of 2 arms. At the inclusion the following exams have to be done : clinical exam, panendoscopy, cytologic and histologic analysis and CT-Scan (or MRI). For each visit, the investigator will perform a clinical exam and the subjects should complete some questionnaires themselves from V0 to V3, V6 (12 months) and V9. At the last visit (24 months) the patients will have a CTC-Scan ou MRI.

At the end of the follow-up period (24 months), the data of subjects survival will be recorded during three years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Man or woman age over 18 without upper age limit

2. Social Insured

3. Patient Information and Informed Consent signed by the patient

4. Patient not participating in another trial since the legal time

5. Absence of any previous treatment for cancer of the Upper AeroDigestive Tract (VADS)

6. Patient with primary squamous cell carcinoma of the oral cavity or oropharynx documented by biopsy with histopathologic analysis not older than 1 month

7. curable or operable tumor with radiation under the Tumor, Nodes, Metastasis (TNM) stage, location and the patient's general condition

8. Stage T1 and T2

9. Tumor listed N0 satisfying the following conditions (21 days validity period): A) absence of lymphadenopathy palpable on clinical examination of the ENT investigator. B) CT scan or MRI with injection of contrast product: lack of suspicious adenomegaly for metastasis = node size less than one centimeter and 1.5 cm for the group IIa, ovoid, homogeneous, not taking contrast and showing no signs of lymph perinodal invasion ( hyperdensity fat, vascular adhesion), absence of lymph node group (> 3)

10. Systematic ENT endoscopy eliminating a second synchronous tumor and precisely establishing the T (21 days validity period)

11. Absence of metastasis: M0

Exclusion criteria:

1. Failure of one of the inclusion criteria

2. Other cancer being treated

3. Non-invasive tumor: high-grade dysplasia, carcinoma in situ

4. Inadequate tumor excision: margins invaded without further recovery in safe zone

5. Contraindications to surgery such sentinel node or lymph node dissection

6. Contraindications to radiotherapy

7. Contraindications to performing a scan:

• Known allergy or intolerance to the injected product and particularly with Technetium-99

• Pregnancy

8. Refusal to accept the full treatment regardless of the strategy

9. Follow-up not possible

10. Refusal to accept the described follow-up and / or provide the necessary information for the study

11. Patient already treated for the tumor outside an excision biopsy

12. Patient who previously had chemotherapy or immunotherapy for another cancer outside VADS within less than 6 months

13. Patient undergoing cervical or VADS radiotherapy whatever the cause or time

14. Patient who have had cervical spine surgery regardless of the cause or time

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Tumors

Intervention

Other:
• Surgery: GS strategy
sentinel node biopsy
• Surgery: Classic strategy
systematic lymphadenectomy

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nodal recurrence rate	The absence of recurrence at 2 years will be affirmed by the absence of clinical signs confirmed by a medical imaging exam.	24 months after the surgery	No
Secondary	Evaluation of quality of life with Head and Neck 35 (H&N35)	Evaluate quality of life on the two years of the follow up	At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery	No
Secondary	Evaluation of the costs	The costs will be collected Under usual forms as the direct, indirect and intangible costs, directly to the relevant services and patients themselves	At the inclusion, and at 2, 4, 6, 8, 10, 12 16, 20 and 24 months after the surgery	No
Secondary	Evaluation of quality of life with Quality of Life Questionnaire Core 30 (QLQ-C30)	Evaluate quality of life on the two years of the follow up	At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery	No
Secondary	Evaluation of quality of life with EuroQOL 5D (EQ 5D)	Evaluate quality of life on the two years of the follow up	At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery	No
Secondary	Evaluation of quality of life with Short Form 36 (SF36))	Evaluate quality of life on the two years of the follow up	At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery	No