Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retrop... | Recruiting
Surgery With or Without Radiation T... | Recruiting
Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma
STRASS

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Medical Conditions
  • Sarcoma
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01344018
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma.

PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.
Research Details
  • OBJECTIVES:

    Primary

    - To assess whether there is a difference in abdominal recurrence-free survival between retroperitoneal soft tissue sarcoma patients undergoing curative intent surgery alone and those undergoing preoperative radiotherapy followed by curative-intent surgery.

    Secondary

    - To assess whether there is a difference in metastasis-free survival, abdominal recurrence-free interval, and overall survival between these patients.

    - To assess tumor response in patients undergoing preoperative radiotherapy.

    - To assess toxicity of preoperative radiotherapy given prior to curative-intent surgery in these patients.

    OUTLINE: This is a multicenter study. Patients are stratified according to institution and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.

    - Arm I: Patients undergo surgical resection of the tumor mass within 4 weeks following randomization.

    - Arm II: Patients undergo 3-dimensional conformal radiation therapy (RT) or intensity-modulated RT within 8 weeks after randomization. RT continues 5 days a week for approximately 5.5 weeks. Patients undergo surgical resection of the tumor mass within 4-8 weeks after the completion of RT.

    Tumor tissue, normal abdominal wall fat, and peripheral blood may be collected during surgery to identify new prognostic factors for translational research.

    After completion of study therapy, patients are followed at day 60 post-surgery and every 6 months thereafter.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Procedure : therapeutic conventional surgery, Radiation : 3-dimensional conformal radiation therapy

Study Arm Groups : Surgery alone, Preoperative radiotherapy followed by en-bloc surgery, Preoperative radiotherapy followed by en-bloc surgery

Intervention Type
See Interventions above
Primary Outcome Measures
    Abdominal recurrence-free survival; null
Secondary Outcome Measures
    Acute toxicity profile of preoperative radiotherapy; null; Perioperative complications; null; Late complications; null; Tumor response to preoperative radiotherapy; null; Time to abdominal recurrence; null; Metastasis-free survival; null; Overall survival; null
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - 120 Years
Who Can Participate
Patients
Number of Participants
256
Participant Inclusion Criteria
    DISEASE CHARACTERISTICS:

    - Histologically confirmed retroperitoneal sarcoma (RPS) by local pathologist, imaging-guided or surgical biopsy, including the following:

    - Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis

    - Sarcoma not originated from bone structure, abdominal, or gynecological viscera

    - Unifocal tumor (not multifocal disease)

    - Absence of extension through the sciatic notch or across the diaphragm

    - The following histological sub-types are not allowed:

    - Gastrointestinal stromal tumor (GIST)

    - Rhabdomyosarcomas

    - Primitive neuroectodermal tumor (PNET) or other small round blue cells sarcoma

    - Osteosarcoma or chondrosarcoma

    - Aggressive fibromatosis

    - Sarcomatoid or metastatic carcinoma

    - No metastatic disease

    - Untreated disease

    - Tumor must be operable and suitable for radiotherapy, based on the following criteria:

    - Pre-treatment CT scan/MRI and multidisciplinary consultation with surgeon, radiation oncologist, and radiologist (anticipated macroscopically complete resection, R0/R1 resection)

    - No surgery anticipated to be R2 on the CT scan before randomization

    - Must have American Society of Anesthesiologist (ASA) score ≤ 2

    - None of the following unresectable criteria:

    - Involvement of superior mesenteric artery

    - Involvement of aorta

    - Involvement of bone

    - Must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT (with IV and PO contrast) or MRI (with IV contrast)

    PATIENT CHARACTERISTICS:

    - WHO performance status 0-2

    - WBC ≥ 2,500/mm^3

    - Platelet count ≥ 80,000/mm^3

    - Total bilirubin < 1.5 times the upper limit normal

    - Calculated creatinine clearance normal

    - Functional contra-lateral kidney to the side involved by the RPS as assessed by intravenous pyelogram

    - Adequate cardiac function (NYHA class I-II)

    - ECG normal (without clinically significant abnormalities)

    - No history of any of the following disorders:

    - Bowel obstruction

    - Mesenteric ischemia

    - Severe chronic inflammatory bowel disease

    - Negative pregnancy test

    - Not pregnant or nursing concurrently and for at least 1 month after the surgery

    - Fertile patients must use effective contraception during the study treatment period and for at least 1 month after the surgery

    - No co-existing malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix

    - No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

    PRIOR CONCURRENT THERAPY:

    - No prior surgery (excluding diagnosis biopsy), radiotherapy, or systemic therapy

    - No prior abdominal or pelvic irradiation for another prior malignancy or other disease

    - No concurrent systemic anticancer treatment (chemotherapy, molecular-targeted therapy)

    - No postoperative radiotherapy planned
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
London
Greater London
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Birmingham
B15 2TH
Manchester
London
NW1 2PG
Newcastle upon Tyne
NE7 7DN
Greenwood Medical Center
Nottingham
Leeds
Bristol
Sheffield
S10 2SJ
Glasgow
G12 0YN
Trial Contact(s)
Primary Trial Contact
Anne Kirkpatrick
+32 27741691
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
EORTC-62092-22092
Sponsor(s)
European Organisation for Research and Treatment of Cancer - EORTC
Key Dates

Recruitment Start Date

Jan 2012

Recruitment End Date

Jan 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

27 Apr 2011

Date updated in source

11 Oct 2016