Docetaxel, Cisplatin (TP) + Radiation +/- Cetuximab in Larynx Carcinoma (CA)

Conditions

Larynx Carcinoma, Squamous Cell Carcinoma of the Hypopharynx

Keywords

by laryngectomy operable carcinoma of the larynx and the hypopharynx

Brief summary

The DeLOS II trial is a multicenter randomised phase II trial investigating a TP/5-Fluorouracil (TPF)-chemotherapy with or without cetuximab for Patients with only by laryngectomy operable carcinoma of the larynx/hypopharynx. Patients were divided in responder or non-responder after 4 weeks. Since August 2009 Responder receive TP with or without Cetuximab + radiation. (Until february 2009 Responder received TPF with or without Cetuximab + radiation.) Planned accrual is 85 patients per treatment arm. The primary study endpoint is a confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation.

Gunnar Wichmann, Theresa Wald, Markus Pirlich, Matthaeus Stoehr, Veit Zebralla et al. (14 authors)

Frontiers in Oncology2024-06-116 citations

10.3389/fonc.2024.1394691

Induction chemotherapy (IC) followed by radiotherapy (RT) versus cetuximab plus IC and RT in advanced laryngeal/hypopharyngeal cancer resectable only by total laryngectomy—final results of the larynx organ preservation trial DeLOS-II

Andreas Dietz, Gunnar Wichmann, Thomas Kuhnt, L. Pfreundner, Rudolf Hagen et al. (44 authors)

Annals of Oncology2018-08-2281 citations

10.1093/annonc/mdy332

Final results of the randomized phase II DeLOS-II trial: Induction chemotherapy (IC) followed by radiotherapy (R) vs. cetuximab (E) plus IC and R for functional larynx preservation in resectable laryngeal and hypopharyngeal cancer (LHSCC).

Andreas Dietz, Gunnar Wichmann, Michael Flentje, Rudolf Hagen, Oliver Koelbl et al. (20 authors)

Journal of Clinical Oncology2016-05-2011 citations

10.1200/jco.2016.34.15_suppl.6025

Induction chemotherapy (IC) docetaxel (T), cisplatin (P), 5-fluorouracil (F) (TPF), or TP followed by concomitant boost radiotherapy (R) with or without cetuximab (E) for functional organ preservation (FOP) of resectable laryngeal and hypopharyngeal cancer (LHSCC): First results of the phase II randomized DeLOS-II study.

Andreas Dietz, Michael Flentje, Rudolf Hagen, Ulrike Bockmuehl, Oliver Koelbl et al. (20 authors)

Journal of Clinical Oncology2014-05-2012 citations

10.1200/jco.2014.32.15_suppl.6016

Interventions

RADIATIONRadiation

Radiation start in week 11

DRUGCetuximab

Day 1 400mg/m2 i.v. than weekly 250 mg/m2 i.v. for 16 weeks

DRUGDocetaxel

75 mg/m2 i.v. day 1 3 times

DRUGCisplatin (TP)

75 mg/m2 i.v. day 1 3 times

DRUG5-Fluorouracil (TPF) (only until Feb 2009)

Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Histologically confirmed, primary only with laryngectomy respectable squamous-cell carcinoma of the larynx or hypopharynx * T3-T4a carcinoma of the glottis * T2-T4a carcinoma of the supraglottic, only controllable by laryngectomy and if applicable by root of tongue segmental resection * T2-T4a carcinoma of the hypopharynx only controllable by laryngectomy (for example T2, post cricoidal) and hypopharynx segmental resection * N-status: cervical metastases (N0-N3) have to be rehabilitate by surgical procedures * Blood count: Leukocytes \>3500/mm\\3, Neutrophils \> 1500/ mm\\3, Thrombocytes \> 8000/ mm\\3 * Clinical chemistry: * adequate renal function, defined by serum creatinine and urea not higher than 25% upper NL, creatinine-clearance \> 60 ml/min/1,72 m\\2 * adequate hepatic function with SGOT, SGPT not higher than 50% and bilirubin not higher than upper NL * electrolytes at NL * anesthetic risk normal or low-grade elevated * age 18-75 years * written informed consent * effective contraception after individual advice for men and women if there is a possibility of reproductive potential (effective contraception are: oral contraception with estrogen and gestagen (no minipill), vaginal ring, contraception patch, estrogen free ovulation suppressors, hormone spiral with progesterone, injection for three month with depot gestagen, hormone releasing implantation (luteal hormone containing rod), abstinence or sterilization (vasectomy) of the male)

Exclusion criteria

* primary cancer treatable by operational larynx -conserving procedures * distant metastases (M1-Status) * total tumor volume exceeding 80 ml or larynx skeleton punctuated with infiltration of surrounding soft tissues respectively the esophageal aditus (exclusive cartilage infiltration represents no

Design outcomes

Primary

Measure	Time frame
Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation	LFS-rate 2 years after randomisation

Secondary

Measure	Time frame
Descriptive analysis of the study arms concerning the secondary end criteria of the study	LSF 2 years after randomisation
Explorative comparison of the study arms concerning the primary and secondary end criteria of the study	LSF 2 years after randomisation

Countries

Austria, Germany

Outcome results

None listed