TPFmORL: Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma

• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04356170
• Collaborator: Centre Leon Berard (Other)
• Enrollment: 99
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.8
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the efficacity of the combination of cisplatin-5-FU and docetaxel in adapted doses in term of response to treatment without toxicity

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Condition or Disease	Intervention/Treatment	Phase
Cancer of Head and Neck	Drug: Docetaxel; Drug: Cisplatin; Drug: Fluoro Uracil	Phase 2

Detailed Description

After explaining the treatment modalities, having read and explained the information letter to them, patients who have signed the consent to participate in the trial and who meet the inclusion criteria will be enrolled and randomized in the trial .

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Randomized Trial, Non Comparative, Evaluating Chemotherapy Associated Cisplatin, 5-fluorouracil and Docetaxel at Adapted Doses in Patients With Locally Advanced Squamous Cell Carcinoma
• Actual Study Start Date: Feb 4, 2021
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TPF (docetaxel, cisplatine, 5-FU) Docetaxel, cisplatine, 5-FU administered, every 3 weeks for a total of 3 cycles	Drug: Docetaxel; Docetaxel 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour; Drug: Cisplatin; cisplatine 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour; Drug: Fluoro Uracil; 750 mg/m²/j administered continuously at D1 to D5 of each cure, every 3 weeks by intravenous infusion ( so 120 hours)
Experimental: TPFm (docetaxel, cisplatine, 5-FU) modifié Docetaxel, cisplatine, 5-FU administered, every 2 weeks for a total of 6 cycles	Drug: Docetaxel; Docetaxel 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour; Drug: Cisplatin; cisplatine 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour; Drug: Fluoro Uracil; 750 mg/m²/j administered continuously at D1 to D5 of each cure, every 3 weeks by intravenous infusion ( so 120 hours)

Outcome Measures

Primary Outcome Measures

1. Efficacity of combination of TPFm [8 weeks after the end of treatment]

   Success rate of patients at 8 weeks

Other Outcome Measures

1. Overall survival [3 months after the end of treatment]

   The time from date of randomization to date of death due to any cause

2. Progression free survival [3 months after the end of treatment]

   The time from date randomization to date of first evidence of progression

3. incidence of local and/or locorégional failure [3 months after the end of treatment]

4. Laryngeal preservation [3 months after the end of treatment]

5. incidence of distant metastatic failure [3 months after the end of treatment]

   The time from the date of randomization and the date of first evidence of metastatic progression, or the date of death, whatever the cause

6. Toxicities of complementary treatment to induction tretatment [3 months after the end of treatment]

   Rate of patients who received the whole of complementary treatment

7. QLQ-C30 questionnaires [8 weeks, 6 months (3 months after the end of treatment) and 24 months after the end of treatment]

   These questionnaires assess the impact of the desease and treatment on tthe patient's life

8. QLQ-H&N35 questionnaires [8 weeks, 6 months (3 months after the end of treatment) and 24 months after the end of treatment]

   These questionnaires assess the impact of the desease and treatment on tthe patient's life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Histologically proven squamous cell carcinoma of the head and neck from one or more of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx, lymphadenopathy without front door

2. Inoperable tumor or tumor whose surgery would be multilating.

The non-operability criteria are:

• Technically impossible resection: fixation / invasion of the tumor at the base of the skull or at the cervical vertebrae, nasopharynx involved, lymph nodes

• Medical selection based on low surgical curability. This category includes all T3-T4 and all N2-N3 (AJCC 8th edition, June 2018)

• Medical selection based on an organ preservation strategy

1. Patient not previously treated for ORL cancer

2. Age > 18 and < 75 years

3. PS 0 or 1 according to WHO

4. At least one lesion measurable according to the RECIST 1.1 criteria

5. Patient who can receive TPF according to the following criteria:

• Adequate hematological function: neutrophils ³ 1.5 x 109 / l, platelets *100 x 109 / l, hemoglobin 10 g / dl (or 6.2 mmol / l)

• Adequate renal function: calculated creatinine clearance (Cockroft & Gault) or measured ³ 60 ml / min.

• Adequate liver function: normal total bilirubin; ASAT and ALAT less than or equal to 1.5 ´ LNS; PAL less than or equal to 2.5 X LNS

• Grade <2 peripheral neuropathy according to NCI CTCAE v5.0

• No clinical impairment of hearing function

• For patients aged 71 to 74, PS at 0 and considered non-geriatrically fragile (G8 questionnaire and multidimensional assessments proposed by the GERICO group (ADL, MMSE, GDS scale, nutrition, motor skills and balance, geographic and personal situation and assessments) thymic))

1. Estimated life expectancy greater than or equal to 3 months

2. Weight loss of less than 10% during the 3 months before randomization

3. Patient understanding French and able to complete quality of life questionnaires

4. Patient having given written consent before any specific protocol procedure

5. Affiliation to a social security scheme or beneficiary of such a scheme

6. Women of childbearing potential and sexually active men agreeing to use effective contraceptive methods for the duration of treatment and at least 6 months after the last administration of study treatments

7. Patient agrees not to donate sperm for the duration of the treatment and at least 6 months after the last administration of the study treatments

8. Absence of deficiency in dihydropyrimidine dehydrogenase activity determined by uracilemia assay (Uracilemia < 16 ng/mL)

Exclusion Criteria:

1. Cancers of the nasopharynx, sinuses or nasal cavities, and any histology other than squamous cell carcinoma

2. Vaccination against recent or planned yellow fever

3. Known deficiency in dihydropyrimidine dehydrogenase (DPD) or determined by the determination of uricemia.

4. History of other cancer except in situ cervical cancer or controlled basal cell carcinoma. Patients in remission from cancer treated more than 3 years ago are eligible. Patients treated by surgery alone for ORL cancer in the previous 3 years are eligible.

5. Previous treatment of an ORL cancer by chemotherapy or radiotherapy. Patients treated by surgery alone for ORL cancer in the previous 3 years are eligible).

6. Presence of distant metastasis.

7. Participation in a therapeutic trial in the 30 days preceding randomization

8. Concomitant anticancer treatment

9. Patient under chronic treatment (3 months) with corticosteroid whose daily dosage is 10 mg / day of methylprednisolone or equivalent

10. Other existing serious medical pathologies (non-exhaustive list):

• Uncontrolled cardiac pathology despite adequate treatment

• Myocardial infarction in the 6 months preceding randomization

• Neurological or psychiatric history such as dementia, convulsions

• Active infection

• Significant gastrointestinal abnormalities, including those that require parenteral nutrition, active peptic ulcer, and history of surgeries affecting absorption

• Obstructive pulmonary disease requiring hospitalization in the year preceding randomization

• Uncontrolled type II diabetes or other corticosteroid contraindications.

• Moderate or severe eczema

1. Known hypersensitivity to docetaxel, cisplatin 5FU or one of their excipients.

2. Intended concomitant use of phenytoin, carbamazepine, barbiturates or rifampicin

3. Presence, upon selection, of psychological, family, social or geographic factors likely to influence the patient's compliance with the study and monitoring protocol.

4. Pregnant or lactating woman

5. Patient (male or female) of reproductive age who is unable or unwilling to take adequate contraceptive measures during treatment and up to 6 months after the last treatment is administered.

6. Persons deprived of their liberty, under guardianship or curatorship

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Leon Berard	Lyon		France	69008

Sponsors and Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou
• Centre Leon Berard

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
• ClinicalTrials.gov Identifier: NCT04356170
• Other Study ID Numbers: GORTEC 2019-01
• First Posted: Apr 22, 2020
• Last Update Posted: Mar 11, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou: ORL cancer without front door, TPFm, inoperable tumor
• Additional relevant MeSH terms: Head and Neck Neoplasms; Docetaxel; Fluorouracil

Study Results

No Results Posted as of Mar 11, 2022