Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain

NCT00550654 | Terminated Phase 2 Results

• 2 other identifiers: 070230NCI-07-C-0230
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well conformal radiation therapy works in treating patients with metastatic cancer outside the brain.

Conditions

Kidney Cancer; Melanoma (Skin); Metastatic Cancer; Ovarian Cancer; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; recurrent adult soft tissue sarcoma; recurrent melanoma; recurrent osteosarcoma; recurrent renal cell cancer; recurrent uterine sarcoma; stage IV adult soft tissue sarcoma; stage IV melanoma; stage IV uterine sarcoma; ovarian sarcoma; chondrosarcoma; metastatic osteosarcoma; stage IV renal cell cancer; lung metastases; liver metastases; bone metastases

Outcome Measures

Primary Outcomes (1)

• 6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease

  Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a \>/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.

  6 months

Secondary Outcomes (6)

• Number of Participants With Adverse Events

  9 months, 11 days

• Median Time to Local Progression

  6-12 months

• 12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment

  12 months

• Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis

  One to three months of followup

• Pain at Sites of Metastases

  One and three months of follow up

Study Arms (1)

Radiation Therapy in Metastatic Cancer

EXPERIMENTAL

Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.

Other: questionnaire administration; Radiation: 3-dimensional conformal radiation therapy; Radiation: hypofractionated radiation therapy; Radiation: image-guided radiation therapy; Radiation: tomotherapy

Interventions

questionnaire administration OTHER

Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.

Also known as: Brief Pain Inventory

Radiation Therapy in Metastatic Cancer

3-dimensional conformal radiation therapy RADIATION

Conformal radiation therapy improves the ability to spare normal tissues.

Radiation Therapy in Metastatic Cancer

hypofractionated radiation therapy RADIATION

Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.

Radiation Therapy in Metastatic Cancer

image-guided radiation therapy RADIATION

Image guided radiation therapy targets the specific site of disease.

Radiation Therapy in Metastatic Cancer

tomotherapy RADIATION

Tomotherapy is a delivery method which provides megavoltage computed tomography (CT) localization and may provide superior conformality and localization compared to other dynamic intensity modulated radiation therapy techniques.

Radiation Therapy in Metastatic Cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Pathologically confirmed cancer * No active disease at the primary site as assessed by physical examination, clinical evaluation, or site-specific imaging * Measurable metastatic disease meeting the following criteria: * Four or fewer sites of extracranial lesions \< 5 cm in size * If metastatic site(s) is within the lung, the following criteria must be met: * No more than two metastases in the proximal bronchial tree area (defined as 2 cm from the trachea or mainstem bronchi) * Carbon monoxide diffusing capacity (DLCO) \> 30% predicted and forced expiratory volume 1 (FEV1) \> 1.2 L (in patients with more than one metastatic site in the lungs) * If metastatic site(s) is within 2 cm of either kidney, creatinine level must be \< 1.5 times upper limit of normal (ULN) * If metastatic site(s) is within 2 cm of the liver, bilirubin level must be \< 1.5 times ULN * Patients with metastatic disease that meets any of the following criteria are excluded: * Proposed site(s) of treatment has been previously treated with radiotherapy * Metastatic site(s) requires emergent treatment (e.g., spinal cord compression, cauda equina, airway compromise, or life-threatening end-organ dysfunction) * Disease that is untreated or previously treated and progressive in the brain * Pathologic fracture or impending pathologic fracture at the metastatic site * Metastatic site(s) of a disease histology that is known to be sensitive to low doses of radiotherapy (e.g., pure seminoma, lymphoma, or small cell carcinoma) * Patients in whom surgery is deemed an appropriate option as standard of care (e.g., isolated lung metastasis from sarcoma or isolated liver metastasis from colon cancer) but who refuse surgical therapy are eligible PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Life expectancy \> 12 weeks as assessed by the consulting radiation oncologist * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of lupus erythematosus or scleroderma * No known hypersensitivity to therapeutic radiotherapy * No other malignancy within the past 2 years except nonmelanoma skin cancer or in situ malignancies of the cervix, bladder, or head and neck * No unrelated systemic illness that, in the judgment of the investigator, would compromise the patient's ability to tolerate study therapy or would likely interfere with study procedures or results * Able or likely to adhere to study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 2 weeks since prior and no concurrent chemotherapy * Prior or concurrent hormonal agents, including antiandrogens, gonadotropin-releasing hormone agonists, aromatase inhibitors, tamoxifen, or similar agents allowed * No change in systemic therapy for 6 weeks before or within 4 weeks after initiating study radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Melanoma; Neoplasm Metastasis; Ovarian Neoplasms; Sarcoma; Osteosarcoma; Carcinoma, Renal Cell; Chondrosarcoma

Interventions

Radiotherapy, Conformal; Radiotherapy, Image-Guided; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Deborah Citrin, M.D.
• Organization: National Cancer Institute, National Institutes of Health

citrind@mail.nih.gov

301-496-5457

Study Officials

• Deborah E. Citrin, MD

  NCI - Radiation Oncology Branch; ROB

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 30, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 13, 2017
• Results First Posted: September 18, 2012

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)