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Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy (PLANET)

This study has been terminated.
(Safety analysis showed increased grade 5 toxicity in experimental arm.)
Sponsor:
Information provided by (Responsible Party):
Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group
ClinicalTrials.gov Identifier:
NCT01664663
First received: August 10, 2012
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status.


Condition Intervention Phase
Non Small Cell Lung Cancer
Radiation: Standard radiochemotherapy to 68 Gy
Radiation: Dose escalated radiochemotherapy up to 84 Gy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy

Resource links provided by NLM:


Further study details as provided by Swedish Lung Cancer Study Group:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 36 monts after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numbers of patients without progression of locoregional disease [ Time Frame: 36 months after randomization ] [ Designated as safety issue: No ]
    Measured with CT-scan according to the RECIST criteria for response


Other Outcome Measures:
  • Overall survival [ Time Frame: 36 months after randomization ] [ Designated as safety issue: No ]
  • Numbers of patients with adverse events [ Time Frame: Up to 36 months after randomization ] [ Designated as safety issue: Yes ]
    According to CTC version 4.0

  • Quality of life [ Time Frame: Up to 36 months after randomization ] [ Designated as safety issue: No ]
    Measured by questionaires, EORTC QLQ 30 + LC 14


Enrollment: 37
Study Start Date: September 2011
Estimated Study Completion Date: October 2015
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A:Standard radiochemotherapy
Radiotherapy with 2 Gy per fractions 5 fractions a week to 68 Gy to the planning target volume. Three courses of cisplatin 75 mg/m2 day 1and vinorelbine 25 mg/m2 day 1+8. Two courses concomitant with radiation.
Radiation: Standard radiochemotherapy to 68 Gy
Experimental: Arm B Escalated radiochemotherapy
Radiotherapy with 2 Gy per fraction 5 or 6 times a week to 68-84 Gy to the planning target volume due to normal tissue tolerance constraints. Dose to lung tissue, esophagus and spinal cord will be considered. Three courses of cisplatin 75 mg/m2 day 1 and vinorelbine 25 mg/m2 day 1+8 will be given, two courses concomitant with radiation.
Radiation: Dose escalated radiochemotherapy up to 84 Gy

Detailed Description:

This is an open label, multicentre phase II trial of individually escalated radiotherapy up to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same chemotherapy. There are restrictions due to lung function, performance status and pre-treatment weight loss. The main endpoint is progression free survival and additional endpoints are local control, overall survival, toxicity quality of life and relapse pattern.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological diagnosis of NSCLC stage IIIA-B.
  • Nonresectable or medically inoperable patients.
  • No prior chemo- or radiotherapy for NSCLC.
  • PS 0-1.
  • FEV1 > 1 l or > 40% and CO diffusion capacity > 40%.
  • Patient compliance and geographic proximity that allow adequate follow-up.
  • Adequate bone marrow reserve: WBCC >3.0, platelets >100, haemoglobin > 100.
  • Written informed concent.
  • Effective use of contraception.

Exclusion Criteria:

  • Excessive weight loss within 6 months (> 10%).
  • Supraclavicular nodes.
  • Apical tumors-pancoast.
  • T4 tumors with separate manifestations in different lobes.
  • Evidence of active serious infections.
  • Inadequate liver function.
  • Inadequate kidney function.
  • Pregnancy.
  • Breast feeding.
  • Serious concomitant systemic disorder.
  • Second primary malignancy the last 5 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664663

Locations
Sweden
Department of Oncology, Norrlands Universitetssjukhus
Umeå, Norrland, Sweden, 901 85
Department of Oncology, Karolinska University Hospital
Stockholm, Stockholm county, Sweden, 171 76
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Västra Götaland, Sweden, 413 45
Sponsors and Collaborators
Ass. Prof. Jan Nyman
Investigators
Principal Investigator: Jan Nyman, Ass. prof Swedish Lung Cancer Study Group
  More Information

No publications provided

Responsible Party: Ass. Prof. Jan Nyman, Assosiated professor Jan Nyman, Department of Oncology, Sahlgrenska University Hospital, Gotenburg , Sweden, Swedish Lung Cancer Study Group
ClinicalTrials.gov Identifier: NCT01664663     History of Changes
Other Study ID Numbers: PLANET
Study First Received: August 10, 2012
Last Updated: November 18, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Swedish Lung Cancer Study Group:
Radiotherapy
Dose escalation
Normal tissue constraints
Locally advanced disease
Good performance status

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014