NCT00775307

Brief Summary

The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T \< or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_2

Geographic Reach
1 country

40 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2016

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

7.1 years

First QC Date

October 17, 2008

Last Update Submit

September 20, 2019

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-small cell lung cancerStage Iadjuvant therapyAdjuvant Drug Therapy

Outcome Measures

Primary Outcomes (1)

  • Phase II component of the study : Feasibility of regime ; Phase III component of the study : disease-free survival (DFS)

    month

Secondary Outcomes (1)

  • Overall survival (OS), Detailed assessment of compliance, Incidence and severity of AEs and other safety measures, Reporting profile of AEs of interest during long-term follow-up, Rates of loco-regional and distant recurrences, Quality of Life

    month

Study Arms (2)

B

PLACEBO COMPARATOR

Placebo 400 mg/day (24 weeks)

Drug: Placebo

A

EXPERIMENTAL

Pazopanib 400 mg/day (24 weeks)

Drug: PAZOPANIB

Interventions

PAZOPANIBDRUG

400 mg/day (24 weeks)

A
PlaceboDRUG

Placebo 400 mg/day (24 weeks)

B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complete resection of the primary tumour and local extension has to be performed. All margins must be free of microscopical disease. At the time of resection, a complete mediastinal lymph-node resection or lymph-node sampling is required. Surgeons are encouraged to dissect or sample all accessible nodal levels.
  • Single surgically resected pathological stage I NSCLC lesion: consisting of a tumor \< 5 cm in greatest dimension (see TNM staging on Appendix 10).
  • No regional lymph node involvement.
  • Pre-operative petscan
  • Satisfactory healing of surgical wound.
  • Patients \>= 18 and \< 70 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  • Recruited to the study and available to start treatment investigational product at least 4 weeks but no longer that 8 weeks after the surgical resection of the NSCLC.
  • No approved or investigational anti-cancer therapy concurrently or in the 5 years prior to start of study drug, including tumor embolization, chemotherapy, radiation therapy, immunotherapy, hormone therapy, biologic therapy, or anti angiogenic therapy (e.g., inhibitors of VEGF or VEGFR).
  • Adequate organ system function
  • Ability to swallow and retain oral medication.
  • \. A female is eligible to enter and participate in this study if she is of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has undergone:
  • Hysterectomy.
  • Bilateral oophorectomy (ovariectomy).
  • +16 more criteria

You may not qualify if:

  • Prior malignancy. Note: Patients who have had another malignancy and were treated more than 5 years ago and have since been considered cured, or patients with a history of basocellular skin carcinoma or in situ carcinoma of the uterine cervix are eligible.
  • Presence of any concurrent disease or condition that would make the subject inappropriate for study participation including any unresolved or unstable, serious toxicity from prior administration of another investigational drug or any serious medical disorder that would interfere with the subject's safety, obtaining informed consent, or compliance with all study related procedures.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study.
  • History or clinical evidence of nodal or distant metastases (screening of brain metastasis is mandatory).
  • Bronchioalveolar carcinoma of lobar or multi lobar involvement. Bronchioalveolar carcinomas presenting as a discrete solitary radiological mass or nodule are eligible.
  • History of human immunodeficiency virus infection or chronic hepatitis B or C.
  • History of hemoptysis after resection of lung cancer.
  • Clinically significant gastrointestinal anomalies including, but not limited to:
  • Malabsorption syndrome
  • Disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect the absorption of study drug.
  • Active peptic ulcer disease
  • Inflammatory bowel disease
  • Ulcerative colitis, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis or other gastrointestinal condition increasing the risk of perforation.
  • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
  • Presence of active or uncontrolled infection.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Annemasse - CH

Ambilly, 74100, France

Location

Béziers - CH

Béziers, 34525, France

Location

Bobigny - Hôpital Avicenne

Bobigny, 93000, France

Location

Bordeaux - Polyclinique Nord

Bordeaux, 33300, France

Location

Boulogne - Ambroise Paré

Boulogne, France

Location

Caen - Centre François Baclesse

Caen, 14000, France

Location

Caen - CHU Côte de Nacre

Caen, 14000, France

Location

Clamart - Hôpital Percy

Clamart, 92140, France

Location

Clermont Ferrand - CHU

Clermont-Ferrand, 63000, France

Location

Colmar - CH

Colmar, 68000, France

Location

Dax - CH

Dax, 40107, France

Location

Grenoble - CHU

Grenoble, 38000, France

Location

Le Mans - Centre Hospitalier

Le Mans, 72000, France

Location

Lille - Hôpital Calmette

Lille, 59000, France

Location

Mantes La Jolie - CH

Mantes-la-Jolie, 78200, France

Location

Marseille - Hôpital Sainte Marguerite

Marseille, 13000, France

Location

Metz - Clinique Claude Bernard

Metz, 57000, France

Location

Mont de Marsan - CH

Mont-de-Marsan, 40000, France

Location

Montpellier - Clinique Clémentville

Montpellier, 34070, France

Location

Montpellier - CHRU

Montpellier, 34295, France

Location

Moulins - CH

Moulins, 03000, France

Location

Nantes - Centre René Gauducheau

Nantes, 44805, France

Location

Nevers - CH

Nevers, 58033, France

Location

CHU

Nîmes, France

Location

Orléans - CH

Orléans, 45000, France

Location

Paris - Saint Louis

Paris, 75000, France

Location

Paris - hôpital Saint-Antoine

Paris, 75012, France

Location

Paris - Hopital Tenon

Paris, 75020, France

Location

Pau - CH

Pau, 64046, France

Location

Centre Catalan d'Onologie

Perpignan, 66000, France

Location

Lyon Sud

Pierre-Bénite, 69495, France

Location

Reims - CHU

Reims, 51092, France

Location

Rennes - CHU

Rennes, 35033, France

Location

Strasbourg - NHC

Strasbourg, 63000, France

Location

Thonon les bains - CH

Thonon-les-Bains, 74200, France

Location

Toulon - HIA

Toulon, 83000, France

Location

Toulouse - CHU Larrey

Toulouse, France

Location

Nancy - CHU

Vandœuvre-lès-Nancy, 54500, France

Location

Vesoul - CHI

Vesoul, 70000, France

Location

Villejuif - Institut Gustave Roussy

Villejuif, 94800, France

Location

Related Publications (1)

  • Besse B, Mazieres J, Ribassin-Majed L, Barlesi F, Bennouna J, Gervais R, Moreau L, Berard H, Debieuvre D, Molinier O, Moro-Sibilot D, Souquet PJ, Jacquot S, Petit L, Lena H, Pignon JP, Lacas B, Morin F, Milleron B, Zalcman G, Soria JC; Intergroupe Francophone de Cancerologie Thoracique (IFCT). Pazopanib or placebo in completely resected stage I NSCLC patients: results of the phase II IFCT-0703 trial. Ann Oncol. 2017 May 1;28(5):1078-1083. doi: 10.1093/annonc/mdx070.

    PMID: 28327934RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Benjamin BESSE, Dr

    Institut Gustave Roussy (IGR)

    PRINCIPAL INVESTIGATOR

  • Jean-Charles SORIA, Pr

    Institut Gustave Roussy (IGR)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 20, 2008

Study Start

November 1, 2008

Primary Completion

December 1, 2015

Study Completion

April 18, 2016

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations

FR(40)