Cancer T1-N0 or T2-N0 of the Oral Cavity Clinical Trial
— SACOOfficial title:
Open Non-randomized Study on the Management of Operable T1-N0 or T2-N0 Oral Cavity and Oropharynx Cancer and Sentinel Lymph Node in Outpatient Surgery
| NCT number | NCT03545256 |
| Other study ID # | 9787 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 31, 2018 |
| Est. completion date | April 2024 |
This is a single-center pilot study of open-label, non-randomized interventional research based on the outpatient management of 30 patients with T1-N0 or T2-N0 cancer in the oral cavity or oropharynx.
| Status | Recruiting |
| Enrollment | 25 |
| Est. completion date | April 2024 |
| Est. primary completion date | March 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Male or female over 18 years old with no upper age limit - Patient (s) affiliated to a social security system, or beneficiary of such a system - Patient information and informed consent signed by the patient - Patient no longer participating in another trial since legal time - Patient with primary squamous cell carcinoma of the oral cavity or oropharynx documented by biopsy with histological analysis less than 1 month old - Tumor operable by TNM stage, location and general condition of the patient - Systematic Oto-Rhino-Laryngology panendoscopy eliminating a second synchronous tumor and establishing precisely the T - Stage T1 or T2, N0 and M0 - Proposal by a multidisciplinary meeting for tumor surgery and GS technique - Eligibility criteria for ambulatory surgery present - Anesthetic criteria for eligibility for outpatient hospitalization (ref AFAR 29 (2010) 67-72, formalized expert recommendations) including ASA I, II and III score stable - Patient able to understand the nature, purpose and methodology of the study Exclusion Criteria: - lack of one of the inclusion criteria - other cancer being treated - non-infiltrating tumor: high grade dysplasia, carcinoma in situ - insufficient tumor excision: invaded margins without complementary recovery in healthy zone - contraindication to sentinel lymph node surgery or ganglion dissection - contraindication to radiotherapy - contraindications to performing a scintigraphy: - Known allergy or intolerance to the injected product and in particular to Technetium-99 - Pregnancy - Refusal to accept the entire treatment (nodal diagnosis on GS, lymph node dissection pN + follow-up of adjuvant radiotherapy if necessary) - impossible to follow over 2 years - refusal to accept the monitoring described and / or to provide the information necessary for the study - patient already treated for this tumor outside of an excisional biopsy - patient who previously had chemotherapy or immunotherapy for another cancer outside the VADS in a period of less than 6 months - patient who has had cervical or VADS radiotherapy regardless of the cause or delay - patient who has had previous cervical surgery regardless of cause or delay - Patient protected by law (patient under guardianship). - Patient (e) deprived of liberty by administrative decision. - Pregnant or lactating women according to article L1121-5 of the CSP. An assay of ßHCG will be performed routinely to ensure the absence of pregnancy. |
| Country | Name | City | State |
|---|---|---|---|
| France | Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche | Montpellier | Hérault |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
Burcia V, Costes V, Faillie JL, Gardiner Q, de Verbizier D, Cartier C, Jouzdani E, Crampette L, Guerrier B, Garrel R. Neck restaging with sentinel node biopsy in T1-T2N0 oral and oropharyngeal cancer: Why and how? Otolaryngol Head Neck Surg. 2010 Apr;142( — View Citation
Garrel R, Poissonnet G, Temam S, Dolivet G, Fakhry N, de Raucourt D. Review of sentinel node procedure in cN0 head and neck squamous cell carcinomas. Guidelines from the French evaluation cooperative subgroup of GETTEC. Eur Ann Otorhinolaryngol Head Neck — View Citation
Lee MK, Nalliah RP, Kim MK, Elangovan S, Allareddy V, Kumar-Gajendrareddy P, Allareddy V. Prevalence and impact of complications on outcomes in patients hospitalized for oral and oropharyngeal cancer treatment. Oral Surg Oral Med Oral Pathol Oral Radiol E — View Citation
Schilling C, Stoeckli SJ, Haerle SK, Broglie MA, Huber GF, Sorensen JA, Bakholdt V, Krogdahl A, von Buchwald C, Bilde A, Sebbesen LR, Odell E, Gurney B, O'Doherty M, de Bree R, Bloemena E, Flach GB, Villarreal PM, Fresno Forcelledo MF, Junquera Gutierrez — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Conversion rate in complete hospitalization or re-hospitalization within 10 days following the surgical procedure (D0) | the conversion into complete hospitalization on the day of the procedure (Day 0) or re-hospitalization within 10 days following the surgical procedure (Day 0) respectively will be performed in case of medical or surgical complications or according to the doctor's opinion for the release of the patient, or in case of lymph nodes dissection | From Day 0 to 10 days post surgery | |
| Secondary | Acceptance rate of outpatient surgery | Acceptance rate of outpatient surgery validated by the multidisciplinary meeting and proposed to the patient who meets the eligibility criteria for the inclusion visit | inclusion visit | |
| Secondary | Description of complications attributable to outpatient care taken on Day 0, Day 10 and Month1 | All complications related to outpatient care will be recorded | From Day 0 to Month 1 post surgery | |
| Secondary | Quality of life at inclusion visit | self-questionnaire completed by the patient at inclusion visit, Score reported by the subjects on the Quality of life questionnaire QLQ-C30. The scores of the different scales are between 0 and 100. A score of the overall health of quality of life (QoL) close to 100 indicates a QoL close to perfect health. Similarly, a score of a functional scale close to 100 represents a level close to perfect capacity. | Inclusion visit | |
| Secondary | Quality of life at Day 0 visit | self-questionnaire completed by the patient at visit Day 0 visit, Scores reported by the subjects on the Quality of life questionnaires QLQ-H & N35.
The questionnaire EORTC QLQ- H & N35 contains 35 questions that incorporate 7 multidimensional scales that assess pain, swallowing, senses (taste and smell), speech, socializing, social contacts, and sexuality during the previous week. It also includes 11 isolated items. The scoring approach for the QLQ-H & N35 questionnaire is identical in principle to that of the QLQC30 questionnaire symptom scales. |
Day 0 visit | |
| Secondary | Quality of life at Day 10 post surgery | self-questionnaire completed by the patient at visit Day 10 visit, Scores reported by the subjects on the Quality of life questionnaires QLQ-H & N35.
The questionnaire EORTC QLQ- H & N35 contains 35 questions that incorporate 7 multidimensional scales that assess pain, swallowing, senses (taste and smell), speech, socializing, social contacts, and sexuality during the previous week. It also includes 11 isolated items. The scoring approach for the QLQ-H & N35 questionnaire is identical in principle to that of the QLQC30 questionnaire symptom scales. |
Day 10 visit post surgery | |
| Secondary | Quality of life at month 1 post surgery | self-questionnaire completed by the patient at inclusion Month 1 visit. Scores reported by the subjects on the Quality of life questionnaire SF-36.Score from the worst health condition imaginable (0) to the best state of health imaginable (100). | Month 1 visit post surgery | |
| Secondary | Evaluation of the cost of the strategy at Month 1 | Description: The cost will be evaluated on the first month of outpatient management | Month 1 |