CO(Mbined Therapy of Malignant) S(Alivary Gland tu)M(Ours With)I(MRT and) c(Arbon Ions): COSMIC

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01154270
First received: June 29, 2010
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

The COSMIC trial is a prospective, mono-centric, phase II trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local control, disease-free survival, and toxicity. Planned accrual of the trial includes 54 patients with histologically proved (≥R1-resected, inoperable or Pn+) salivary gland malignancies. Treatment consists of 24 GyE carbon ions (8 fractions) and 50 Gy IMRT (2.0 Gy/ fraction).


Condition Intervention Phase
Malignancy
Salivary Glands
Tumor
Radiation: carbon ion boost
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Therapy of Malignant Salivary Gland Tumours With IMRT and Carbon Ions: COSMIC

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • mucositis ≥ CTC°3 [ Time Frame: 6-8 weeks post completion of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • local control [ Time Frame: 3 years post RT ] [ Designated as safety issue: No ]
    to evaluate local control at 3 years post RT

  • acute toxicity [ Time Frame: 6-8 weeks post completion of treatment ] [ Designated as safety issue: Yes ]
    evaluation of acute radiation effects (other than mucositis CTC°C) 6-8 weeks post completion of treatment

  • late toxicity [ Time Frame: 3 years post radiotherapy ] [ Designated as safety issue: Yes ]
    to evaluate radiation late effects

  • disease-free survival [ Time Frame: 3 years post treatment ] [ Designated as safety issue: No ]
    to evaluate disease-free survival at 3 years post radiotherapy


Estimated Enrollment: 54
Study Start Date: June 2010
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT + C12-boost
(8 x 3 GyE) carbon ion therapy followed by 50 Gy IMRT (2 Gy/ Fx)corresponding to a total dose of approximately 74 GyE.
Radiation: carbon ion boost
8 fractions carbon ion (8 x 3 GyE C12) therapy followed by 25 fractions of IMRT corresponding to a total dose of approximately 74 GyE. Treatment duration is approximately 61/2-7 weeks

Detailed Description:

Local control in malignant salivary gland tumours is dose dependent. High local control rates in adenoid cystic carcinomas could be achieved by highly conformal radiotherapy techniques and particle (neutron/ carbon ion) therapy. Considering high doses are needed to achieve local control, all malignant salivary gland tumours probably profit from the use of particle therapy, which in case of carbon ion treatment, has been shown to be accompanied by only mild side-effects.

Methods/ design:

The COSMIC trial is a prospective, mono-centric, phase II trial evaluating toxicity in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost in 54 patients with histologically proved (≥R1-resected, inoperable or Pn+) salivary gland malignancies. Patients receive 24 GyE carbon ions (8 fractions) and IMRT (2.0 Gy/ fraction).

Study objectives:

Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local control, disease-free survival, toxicity (incl. mucositis CTC °I-II and late toxicity at 3 years post RT)

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed or surgically removed malignant tumour of the salivary glands (head and neck)
  • Inoperable tumour
  • G2/3
  • Macroscopic or microscopic residual tumour (R2/ R1) or
  • ≥T3/T4 or
  • perineural invasion (Pn+)
  • written informed consent
  • pts aged 18 - 80 years
  • effective contraception for pts in childbearing age (<12 months post beginning of menopause)

Exclusion Criteria:

  • Prior radio- or chemotherapy for tumours of the head and neck
  • Other previous malignancy within the past 5 years except prior, adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  • Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators
  • Legal incapacity or limited legal capacity
  • Positive serum/ urine beta-HCG/ pregnancy
  • Drug abuse
  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: NCT01154270

Locations
Germany
Dept. of Radiation Oncology, INF 400
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Marc W Muenter, MD Dept. of Radiation Oncology, INF 400, 69120 Heidelberg
  More Information

Publications:
Krempien R, Münter MW, Timke C, Friess H, Hartung G, Herfarth KK, et al. Cetuximab in combination with intensity modulated radiotherapy (IMRT) and gemcitabine for patients with locally advanced pancreatic cancer: a prospective phase II trial [PARC-study ISRCTN56652283]. J Clin Oncol 2007; 25 (18S) 4573

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. MW Münter, Dept. of Radiation Oncology
ClinicalTrials.gov Identifier: NCT01154270     History of Changes
Other Study ID Numbers: COSMIC
Study First Received: June 29, 2010
Last Updated: April 23, 2013
Health Authority: Germany: "Bundesamt für Strahlenschutz" (German Radiation Protection Authority)

Keywords provided by Heidelberg University:
cancer of the salivary glands
radiation
carbon ion therapy

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014