Chimioradiothérapie à dose ajustée dans le cancer de l'oropharynx associé au VPH chez les personnes âgées ((DACHOC-E))
Essai pilote de faisabilité de la chimioradiothérapie à dose ajustée dans le cancer de l'oropharynx associé au VPH chez les personnes âgées (DACHOC-E)
Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.
For this reason this study is looking at a different regimen of reducing the intensity of the treatment.
The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
There will be about 30 people taking part in this study. This study has one study group. All the people on the study will receive radiation therapy once a day, 5 days a week (for a total of 55 Gy over 5 weeks) and chemotherapy, cisplatin, (given through the vein for about 30-60 minutes) once a week for 5 weeks.
Medications and saline solutions to prevent side effects of chemotherapy may also be given by vein and may prolong your time in the chemotherapy clinic to as much as 4-6 hours.
Standard regimen not delivered on this study pertains to radiation therapy and chemotherapy, cisplatin in a schedule of 5 treatments a week for a total of 69.96 Gy over 6.5 weeks.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Regulatory Office
- Numéro de téléphone: 904-202-7300
- E-mail: RegBMDA@bmcjax.com
Sauvegarde des contacts de l'étude
- Nom: Clinical Trials Office
- E-mail: clinicaltrialsdivision@bmcjax.com
Lieux d'étude
-
-
Florida
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Jacksonville, Florida, États-Unis, 32207
- Recrutement
- Baptist MD Anderson Cancer Center
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Contact:
- Clinical Trials and Translational Medicine Divsion
- E-mail: clinicaltrialsdivision@bmcjax.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
- Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
- P16-positive based on local site immunohistochemical tissue staining
- Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
- Age ≥ 65.
- Normal organ and marrow function within 14 days prior to registration defined as follows:
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5× institutional upper limit of normal (ULN)
- AST(SGOT) or ALT(SGPT) ≤ 3.0 × institutional ULN
- Serum creatinine ≤ 1.5× ULN
Exclusion Criteria:
- Metastatic disease
- Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries
- Synchronous double primaries
- Prior radiotherapy for lymphoma or other malignancy
- Prior systemic therapy including immunotherapy
- Severe active comorbidity where life expectancy is <1 year.
- Autoimmune disease
- Uncontrolled HIV
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Experimental
Cisplatin: 30-40 mg/m2/week, every week during radiation. Dose should be based on actual body weight. The first cisplatin infusion should be started within 24 hours before or after the first scheduled radiation treatment. Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT) are mandatory for this study. 55 Gy radiation in 5 weeks using 5 fractions per week + Cisplatin every week |
Instead of standard bilateral or extensive neck fields, the current radiation fields will cover disease with only 3cm expansion. The clinical target volumes doses are biologically equivalent to the standard but given in a shorter hypofractionated approach. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Two-year progression free survival
Délai: 2 years
|
Assuming the primary endpoint (non-inferior 2 year locoregional control) is met and both of these toxicity outcome goals are met, then concurrent short course radiotherapy would be considered an effective and less toxic alternative to concurrent standard arm, in locally advanced HPV-associated carcinoma of the oropharynx. |
2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Benefit and Tolerance of Treatment
Délai: 2 years
|
Frailty index G8 score 14 as major determinant of benefit and tolerance to treatment through: Per prior study score <14 (1-17) is an indicator of frailty. The frailty as a factor in completing therapy (yes or no) and number of days break from therapy will be used as a variable. G20 frailty index (G-20 is the actual name and not abbreviation) is as follows: A Has food intake declined over the past 3 months due to loss of appetite, digestive problems, chewing or swallowing difficulties? B Weight loss during the last 3 months C Mobility D Neuropsychological problems E Body Mass Index (BMI (weight in kg) / (height in m²) F Takes more than 3 medications per day G In comparison with other people of the same age, how does the patient consider his/her health status? H Age |
2 years
|
|
Acute Toxicity
Délai: 2 years
|
Acute toxicity (Grade 3 or higher) |
2 years
|
|
Late toxicity
Délai: 2 years
|
Late toxicity (Grade 3 or higher) |
2 years
|
|
Failure pattern
Délai: 2 years
|
Pattern failure (local in field, local marginal miss, local regional failure, distant failure, combination of the above). As some of the patient may have recurrence in the radiation fields, this will be termed local recurrence. Recurrence outside the radiation fields but in the head and neck area will be quantified as regional failure. Failure outside the head and neck area will be classified as distant failure. This outcome will be quantified as global number of failure out of the 20 patients and their distribution will be quantified in a diagram as explain above. |
2 years
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BMDA-2301
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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