Trial record 1 of 276 for:    Open Studies | "Rectal Neoplasms"
Previous Study | Return to List | Next Study

Symptoms and Quality of Life (QoL) After Palliative Pelvic Radiation of Prostate and Rectal Cancers (PallRad1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sorlandet Hospital HF
Sponsor:
Collaborators:
Oslo University Hospital
Sykehuset Innlandet HF
Nordlandssykehuset HF
University Hospital of North Norway
Helse Stavanger HF
Alesund Hospital
Trondheim University Hospital
Information provided by (Responsible Party):
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT01023529
First received: November 30, 2009
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to assess the effect of palliative pelvic radiation on symptoms and quality of life among patients with incurable prostate and rectal cancer.


Condition Intervention
Prostatic Neoplasms
Rectal Neoplasms
Radiation: Palliative pelvic soft-tissue radiation (external beam)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Multicenter Study of Symptoms and QOL in Patients With Prostate and Rectal Cancers Receiving Palliative Pelvic Radiation

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Effect on patient's target symptom. [ Time Frame: at end of treatment and 6 weeks and 12 weeks after treatment completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect on patient's QoL. [ Time Frame: at end of treatment and 6 and 12 weeks after treatment completion. ] [ Designated as safety issue: No ]
  • Time to improvement in patient's symptoms and QoL. [ Time Frame: at end of treatment and 6 and 12 weeks after treatment completion. ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2009
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prostate cancer
Patients with incurable prostate cancer requiring palliation of symptoms from a soft-tissue pelvic tumor.
Radiation: Palliative pelvic soft-tissue radiation (external beam)
3 Gy x 10-13 (range 30 - 39 Gy total)
Rectal Cancer
Patients with incurable rectal cancer requiring palliation of symptoms from a soft-tissue pelvic tumor.
Radiation: Palliative pelvic soft-tissue radiation (external beam)
3 Gy x 10-13 (range 30 - 39 Gy total)

Detailed Description:

With the aging population, the prevalence of cancer is on the rise, leading to an increased demand for effective palliative treatment. There is little scientific information describing the effects of palliative radiotherapy among patients treated for soft-tissue tumors of the pelvis. This is a treatment that is used relatively frequently, but delivered heterogeneously since the optimum fractionation schedule has yet to be established. This study aims to define the effects of one such fractionation schedule (3Gy x 10-13) and thus, establish a foundation for future fractionation studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Symptomatic patients referred for palliative pelvic radiotherapy of prostate and rectosigmoid cancers.

Criteria

Inclusion criteria:

  • Age ≥ 18 years
  • Histologically or cytologically proven adenocarcinoma of the prostate or rectosigmoid colon.
  • Incurable disease (hormone-resistant in cases of prostate cancer)
  • Life expectancy > 3 months
  • Symptomatic soft-tissue pelvic tumor mass (primary, recurrence or metastases)
  • Planned fractionated radiotherapy (3Gy x 10-13)
  • Written informed consent

Exclusion criteria:

  • Unable to fill out questionnaires (due to language or cognitive barriers)
  • New systemic tumor-targeted treatment (hormone manipulation, chemotherapy, monoclonal antibodies, etc.) started within four weeks of baseline or during the 6 weeks immediately following pelvic radiotherapy.
  • Previous pelvic radiotherapy
  • The presence of a second primary pelvic cancer or other cancer requiring treatment
  • Currently receiving treatment with an investigational drug
  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: NCT01023529

Contacts
Contact: Christian Kersten, MD PhD +47 38 14 66 00 Christian.Kersten@sshf.no
Contact: Marte Cameron, MD +47 38 14 66 00 Marte.Gronlie.Cameron@sshf.no

Locations
Norway
Stavanger University Hospital Recruiting
Stavanger, Rogaland, Norway
Contact: Trond Aagedal, MD       trond.aagedal@sus.no   
Contact: Janet E Eik, MD       janet.elisabeth.eik@sus.no   
Nordland Hospital, Bodø Recruiting
Bodø, Norway
Contact: Carsten Nieder, MD PhD       Carsten.Nieder@nordlandssykehuset.no   
Innlandet Hospital Trust, Gjøvik Recruiting
Gjøvik, Norway
Contact: Kjetil Weyde, MD       Kjetil.Weyde@sykehuset-innlandet.no   
Center for Cancer Treatment, Sorlandet Hospital HF Recruiting
Kristiansand, Norway, 4604
Contact: Christian Kersten, MD PhD       Christian.Kersten@sshf.no   
Contact: Marte Cameron, MD       Marte.gronlie.cameron@sshf.no   
The Cancer Center, Ullevål University Hospital Recruiting
Oslo, Norway, 0407
Contact: Marianne G Guren, MD PhD       marianne.guren@medisin.uio.no   
Contact: Christine Undseth, MD       Christine.Undseth@ulleval.no   
University Hospital of Northern Norway (Tromsø) Recruiting
Tromsø, Norway
Contact: Ola Magne Vagnildhaug, MD       Ola.Magne.Vagnildhaug@unn.no   
Contact: Kirsten Marienhagen, MD         
St. Olav's Hospital Recruiting
Trondheim, Norway
Contact: Ingunn Hatlevold, MD       ingunn.hatlevold@stolav.no   
Contact: Eva Hofsli, MD       eva.hofsli@stolav.no   
Ålesund Hospital Recruiting
Ålesund, Norway
Contact: Tatiana M Abramova, MD       Tatiana.Mikhailovna.Abramova@else-mr.no   
Sponsors and Collaborators
Sorlandet Hospital HF
Oslo University Hospital
Sykehuset Innlandet HF
Nordlandssykehuset HF
University Hospital of North Norway
Helse Stavanger HF
Alesund Hospital
Trondheim University Hospital
  More Information

No publications provided

Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT01023529     History of Changes
Other Study ID Numbers: 2009-1684(REK)
Study First Received: November 30, 2009
Last Updated: June 30, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Sorlandet Hospital HF:
Prostatic Neoplasms
Rectal Neoplasms
Palliative treatment
Radiotherapy
Quality of life

Additional relevant MeSH terms:
Rectal Neoplasms
Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014