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NCT Number: NCT01074697

Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin

GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist (fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting) control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy.

The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug regimen (standard treatment) in preventing nausea and vomiting in patients receiving radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.

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Key information

Conditions

Nausea Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Urogenital Neoplasms Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

RAH Cancer Centre, Royal Adelaide Hospital, Adelaide SA, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(abbreviated)

  • The patient has a diagnosis cervical cancer.
  • The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
  • The patient is aged > 18 years.
  • The patient must be both chemo- and radiotherapy (RT) naïve. NB: previously low voltage RT or electron RT for non-melanoma skin cancers is allowed.
  • The patient is scheduled to receive fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2 for at least five weeks.
  • Brachy therapy is scheduled to be initiated after the third cycle of weekly cisplatin, and preferentially after the fifth week of treatment.
  • Chemotherapy with an emetic risk potential of minimal or mild (up to 30%) is allowed on days 1-4 (see ref. 14).
  • The patient has a WHO Performance Status of ≤ 2.

Exclusion criteria

(abbreviated)

  • The patient has a current malignant diagnosis other than cervical cancer, with exception of non-melanoma skin cancers.
  • The patient is aged < 18 years.
  • The patient is scheduled to receive less than five weeks of fractionated radiotherapy and concomitant weekly cisplatin.
  • Brachy therapy is planned to be initiated before the third cycle of weekly cisplatin.
  • The patient has been previously treated with radiotherapy, and/or chemotherapy, with exception of treatment with low voltage RT or electron RT for non-melanoma skin cancers .
  • The patient has a WHO Performance Status of > 2.

Treatment and study plan

fosaprepitant dimeglumine

Drug

Addition of fosaprepitant dimeglumine 150 mg IV single dose weekly (before chemotherapy) to dexamethasone and palonosetron.

Other names: Palonosetron, Dexamethasone

Placebo

Drug

Saline water

Primary outcomes

  1. To compare fosaprepitant dimeglumine, palonosetron, and dexamethasone with palonosetron, dexamethasone, and placebo with respect to efficacy; the proportion of subjects with no vomiting during five weeks of radiotherapy and concomitant weekly cisplatin.

    Time frame: 35 days

Secondary outcomes

  1. To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with complete response in the 7 days following initiation of radiotherapy and concomitant weekly cisplatin.

    Time frame: 7 days

  2. To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with no significant nausea during five weeks of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.

    Time frame: 35 days

  3. To compare the fosaprepitant dimeglumine regimen and the control regimen with respect to complete response in the 35 days following initiation of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.

    Time frame: 35 days

  4. To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with no nausea during five weeks (35 days) of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.

    Time frame: 35 days

  5. To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the number of days to first emetic episode.

    Time frame: 0-35 days

  6. To compare quality of life using the FLIE questionnaire.

    Time frame: 0-35 days

  7. To compare tolerability of both regimens.

    Time frame: 0-35 days

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Helsinn Healthcare SA

Registry information

Official study title

A Multinational, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Tolerability of Palonosetron and Dexamethasone Plus Fosaprepitant or Placebo in Patients Receiving Radiotherapy and Weekly Cisplatin.

Acronym: GAND-emesis

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Feb 24, 2010
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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