SarcomaPhase 1NCT00004109
Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
A Phase 1 study testing Doxorubicin Hydrochloride and Radiation Therapy (RT) in people with Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Doxorubicin Hydrochloride and Radiation Therapy (RT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1998to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have cytologic or histologic proof of large (>5 mc), Grade III, resectable soft tissue sarcoma of the extremity or trunk (AJCC Stage IIIB). Patients with The American Joint Committee on Cancer (AJCC) Stage IIB tumors (Grade II) greater than 8 cms will also be eligible.
- Patients may have measurable or non-measurable disease (C/P pre-referral excision).
- Patients may have had prior doxorubicin (up to a total doxorubicin dose of 450 mg/m2).
- Patients may have a prior history of malignancy (at the discretion of the Principal Investigator).
- Patients must have Karnofsky Point Scale (P.S.)> of >70 or Xubrod P.S. of 0 or 1.
- Patients must have: Absolute neutrophil count (ANC) > 1,500 cells/mm; platelet count > 100,000 platelets/ml; serum creatinine <1.8 mg/dl, aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) < 3 times normal, total bilirubin < 1.5mg/dl; for patients with cumulative Adriamycin 450 mg/M2, EF >50%.
- Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception.
Who cannot join
- Patients must not have had prior radiation therapy (XRT) in the area of the primary tumor, and the anticipated XRT field must not include the perineum, scrotum, or vaginal introitus.
- Patients with uncontrolled coexisting medical conditions are excluded.
- Patient must not be pregnant or brest feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation therapy in treating patients who have soft tissue sarcoma.
Read the detailed description
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of doxorubicin when combined with external beam radiotherapy in patients with high risk soft tissue sarcomas of the extremity or trunk. II. Assess the radiographic and pathologic response rates to this preoperative regimen in the subset of these patients with measurable disease.
OUTLINE: This is a dose escalation study of doxorubicin. Patients receive doxorubicin intravenous (IV) bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks in the absence of unacceptable toxicity. Patients with measurable disease receive external beam radiotherapy 5 days a week for 5 weeks concurrently with doxorubicin treatment. Patients with measurable disease undergo surgical resection of the residual mass 4-7 weeks following completion of chemoradiation. Patients who have no measurable disease and have undergone prereferral excision undergo surgical resection of the prior surgical scar and tumor bed followed by external beam radiotherapy 5 days a week for 5 weeks. Cohorts of 3 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. Patients are followed every 3 months for 3 years, every 4 months for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study at a rate of 5-6 patients per month.
- Conditions
- Sarcoma
- Being tested
- Doxorubicin Hydrochloride, Radiation Therapy (RT)
- Keywords
- stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, Doxorubicin, External-Beam RT, XRT, cancer, PREOPERATIVE CONCURRENT CHEMORADIATION, EXTREMITY SOFT TISSUE SARCOMAS, TRUNK SOFT TISSUE SARCOMAS, Concurrent Chemoradiation, Surgical Resection, Localized Extremity Soft Tissue Sarcomas, Body Wall Soft Tissue Sarcomas
- Medical subject headings
- Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called doxorubicin
Doxorubicin dose will not exceed 20 mg/m2 per week IV over 4 days every week for 5 weeks
Radiation Therapy (RT)Radiation
Also called RT, Radialtherapy
External-beam radiotherapy at a dose of 50 Gy (2.0 x 25 fractions, weeks 1-5).
| Study group | Role | What they receive |
|---|---|---|
| Doxorubicin + External-Beam RT | Experimental | Not described Receives: Drug: Doxorubicin Hydrochloride; Radiation: Radiation Therapy (RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
MTD of doxorubicin intravenous (IV) based on presence of dose limiting toxicities. For dose-finding purposes, a dose-limiting toxicity (DLT) was defined as grade 3 or greater treatment-related cutaneous toxicity
Measured: Continousouly during 5 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2004 (estimated)
- Study startMar 1998
- Primary completionSep 2001
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Peter W. Pisters, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004109
- Sponsor's protocol ID
- ID97-335
- Other IDs
- P30CA016672, MDA-ID-97335, NCI-G99-1598, CDR0000067332
- Status last verified
- Aug 2012
- First submitted
- 10 Dec 1999
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT00004109
- Acronym / sponsor ID
- ID97-335
- Conditions
- Sarcoma
- Keywords
- stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, Doxorubicin, External-Beam RT, XRT, cancer, PREOPERATIVE CONCURRENT CHEMORADIATION, EXTREMITY SOFT TISSUE SARCOMAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 1998
- Primary completion
- Sep 2001 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation therapy in treating patients who have soft tissue sarcoma.
Detailed description
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of doxorubicin when combined with external beam radiotherapy in patients with high risk soft tissue sarcomas of the extremity or trunk. II. Assess the radiographic and pathologic response rates to this preoperative regimen in the subset of these patients with measurable disease.
OUTLINE: This is a dose escalation study of doxorubicin. Patients receive doxorubicin intravenous (IV) bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks in the absence of unacceptable toxicity. Patients with measurable disease receive external beam radiotherapy 5 days a week for 5 weeks concurrently with doxorubicin treatment. Patients with measurable disease undergo surgical resection of the residual mass 4-7 weeks following completion of chemoradiation. Patients who have no measurable disease and have undergone prereferral excision undergo surgical resection of the prior surgical scar and tumor bed followed by external beam radiotherapy 5 days a week for 5 weeks. Cohorts of 3 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. Patients are followed every 3 months for 3 years, every 4 months for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study at a rate of 5-6 patients per month.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doxorubicin + External-Beam RT | Experimental | Drug: Doxorubicin Hydrochloride, Radiation: Radiation Therapy (RT) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have cytologic or histologic proof of large (>5 mc), Grade III, resectable soft tissue sarcoma of the extremity or trunk (AJCC Stage IIIB). Patients with The American Joint Committee on Cancer (AJCC) Stage IIB tumors (Grade II) greater than 8 cms will also be eligible.
- Patients may have measurable or non-measurable disease (C/P pre-referral excision).
- Patients may have had prior doxorubicin (up to a total doxorubicin dose of 450 mg/m2).
- Patients may have a prior history of malignancy (at the discretion of the Principal Investigator).
- Patients must have Karnofsky Point Scale (P.S.)> of >70 or Xubrod P.S. of 0 or 1.
Key exclusion criteria (3 listed)
- Patients must not have had prior radiation therapy (XRT) in the area of the primary tumor, and the anticipated XRT field must not include the perineum, scrotum, or vaginal introitus.
- Patients with uncontrolled coexisting medical conditions are excluded.
- Patient must not be pregnant or brest feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxorubicin HydrochlorideAlso: doxorubicinDoxorubicin dose will not exceed 20 mg/m2 per week IV over 4 days every week for 5 weeks | Drug | Doxorubicin + External-Beam RT |
| Radiation Therapy (RT)Also: RT, RadialtherapyExternal-beam radiotherapy at a dose of 50 Gy (2.0 x 25 fractions, weeks 1-5). | Radiation | Doxorubicin + External-Beam RT |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Continousouly during 5 weeks treatment
MTD of doxorubicin intravenous (IV) based on presence of dose limiting toxicities. For dose-finding purposes, a dose-limiting toxicity (DLT) was defined as grade 3 or greater treatment-related cutaneous toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter W. Pisters, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxorubicin Hydrochloride and Radiation Therapy (RT) in people with Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: Continousouly during 5 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.