High Precision RT For Soft-Tissue Sarcoma

NCT01389050 | Completed Phase 2

• 1 other identifier: UHN REB 10-0854-CE
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This research study aims at defining 1) how retroperitoneal sarcomas change over the course of radiotherapy and 2) how radiotherapy affects your well-being. While the investigators know that radiotherapy before surgery is safe and effective, the amount of tumor motion and size change during radiotherapy is unknown. There is also very little information that describes the side-effects of radiotherapy in the treatment of this disease.

Conditions

Soft-Tissue Sarcoma

Outcome Measures

Primary Outcomes (2)

• To determine the extent of inter-fractional and intra-fractional movement of the GTV during radiotherapy treatments.

  To quantify and describe the movement of the tumor during and between radiotherapy treatments using imagings acquired during the course of radiotherapy planning and treatments.

  3 years

• To assess the acute and long-term toxicity of pre-operative radiotherapy as a function of the dose given to normal tissues and its impact on patient quality of life.

  To describe the effect of radiotherapy to the patient by measuring the acute and long-term side-effects of radiation therapy.

  10 years

Secondary Outcomes (2)

• Describe variations in the volume and shape of the GTV over the course of the treatment and need for adaptive therapy.

  3 years

• Correlate the pattern of local recurrence with the dose of radiation delivered accounting for motions and volume changes of target structures.

  10 years

Study Arms (2)

Follow-up

NO INTERVENTION

Data from these patients will be added to retrospectively gathered data from the PMH radiotherapy data bank (approximately 50 patients). The data collected will be analyzed using descriptive statistics.

Prospective

EXPERIMENTAL

Radiation: Intensity-Modulated Radiotherapy; Radiation: Daily Cone Beam CT

Interventions

Intensity-Modulated Radiotherapy RADIATION

Radiotherapy for the treatment of retroperitoneal sarcoma. IMRT will be 50.4 Gy given in 28 fractions.

Also known as: Pre-operative IMRT

Prospective

Daily Cone Beam CT RADIATION

Images and information from the daily CT will be used for the repositioning of the patient prior to their treatments as per standard procedures.

Also known as: daily cone-beam Computed Tomography (CT)

Prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically (histologically or cytologically) proven diagnosis of sarcoma (except for GIST, Ewing's sarcoma and rhabdomyosarcoma) within the retroperitoneum. These include patients with locally recurrent disease
• Planned to receive pre-operative radiotherapy
• Will undergo a planning CT
• Karnofsky Performance Status of ≥ 70 within 28 days prior to study entry
• No systemic chemotherapy given prior to pre-operative radiotherapy
• Able to provide written, informed consent
• Women of childbearing potential and men who are sexually active must practice adequate contraception.

You may not qualify if:

• Tumor pathology of GIST, Ewing's sarcoma or rhabdomyosarcoma
• Metastatic disease to the retroperitoneum from a primary sarcoma not originating from the retroperitoneum
• Systemic chemotherapy given prior to pre-operative radiotherapy.
• Intent on giving chemotherapy ≤ 12 months from the completion of radiotherapy
• Inability to undergo a 4D-CT simulation
• KPS \< 70
• Unable to provide informed consent
• Pregnant women

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Charles Catton, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 7, 2011
• Study Start: June 1, 2011
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

CA (1)