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Comparison of Two Concomitant Administration of RT With Cisplatin in Standard Infusion or Fractional Infusion

NCT03330249 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2022-03-11

No results posted yet for this study

Summary

The general aim is to compare the cumulative dose of cisplatin administered concomitantly with radiotherapy in reference arm A (cisplatin 100 mg / m2 day 1 every 21 days) and in the experimental arm B (Cisplatin split 25 mg / m2 / J D1 to D4 all 21 days).

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Split Cisplatin

25 mg/m2/day IV infusion at D1 to D4, at D22 to D25, at D43 to D46 during the radiotherapy.

DRUG

Cisplatin

100 mg/m2/day IV infusion at D1, D22 and D43 during the radiotherapy.

RADIATION

Radiotherapy

70 Gy in 35 fractions of 2 Gy in non-operated patients and 66 Gy in 33 fractions in post-operative.

Sponsors & Collaborators

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Principal Investigators

  • Christian BOREL, MD · Centre Paul Strauss

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-03
Primary Completion
2021-05-10
Completion
2021-05-10

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03330249 on ClinicalTrials.gov