June 2012: Trials in Progress

Published: Friday, Jun 15, 2012
The Trials in Progress section is intended to stimulate discussion about ongoing clinical trials and to promote collaboration across the oncology community. Each month, OBTN will present summaries of ongoing research in a broad range of cancer types.

Supportive Care

Opioid titration order sheet or standard care in treating patients with cancer pain

This phase III study is comparing the use of an opioid titration order sheet versus standard care for the management of cancer pain. An opioid titration order sheet allows healthcare providers to adjust the dosage and schedule of pain medication. The primary outcome measure is pain, including intensity, duration, and painrelated distress. Secondary outcome measures are function, mood, and quality of life. All participants have cancer-related pain and have received at least 1 week of fixed-dose opioid therapy and satisfy any of the following criteria: self-reported inadequate pain control; the need for 2 or more rescue doses per day; or the need for adjustments in their pain regimen involving either fixed or breakthrough dosing.

Sponsor: Vanderbilt-Ingram Cancer Center

ClinicalTrials.gov Identifier: NCT00666211

American ginseng for cancerrelated fatigue

This phase III study intends to determine whether the perennial American ginseng (also known as Panax quinquefolius) improves cancer-related fatigue. Subjects had been diagnosed with cancer within the past 2 years and had a history of cancer-related fatigue as defined by an average score of ≥ 4 over the past 30 days on the numeric analogue scale (1-10). Patients are stratified according to baseline fatigue score, disease status of current cancer, current treatment, duration of all prior cancer treatment in their lifetime, and current tumor type, after which they are randomized to receive oral American ginseng or placebo twice daily for 14 days. Treatment is repeated every 2 weeks for a total of 4 courses. The primary outcome measure is the duration of response as measured by the general subscale Multidimensional Fatigue Symptom Inventory– Short Form (MFSI-SF).

Sponsor: North Central Cancer Treatment Group

ClinicalTrials.gov Identifier: NCT00719563

Women's Cancer

Extraperitoneal para-aortic lymph node dissection for cervical cancer

This phase III study will examine whether extraperitoneal laparoscopic lymphadenectomy followed by chemotherapy and tailored radiation therapy can maintain disease control longer than standard-of-care chemoradiotherapy and wholepelvic radiation therapy in women with locally advanced cervical cancer. Trial participants will include women with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma; women with FDG-PET-positive or indeterminate pelvic lymph nodes and negative para-aortic nodes; and women with planned treatment of primary definitive chemoradiation therapy. The primary outcome measure is 3-year overall survival, and the target recruitment is 480 patients. The study’s primary completion date is slated for September 2019.

Sponsor: MD Anderson Cancer Center

ClinicalTrials.gov Identifier: NCT01365156

Paclitaxel versus polyglutamate paclitaxel or observation only in patients with ovarian epithelial or peritoneal or fallopian tube cancer

This phase III trial of maintenance chemotherapy is comparing 12 monthly cycles of paclitaxel or polyglutamate paclitaxel versus no treatment until relapse in women with advanced ovarian or primary peritoneal or fallopian tube cancer who achieve a complete response to primary platinum/taxane chemotherapy. The primary outcome measure is overall survival. The investigators will also examine progression-free survival, quality of life, and toxicity of the study drugs, particularly peripheral neuropathy. Study participants are stratified according to disease stage at diagnosis, presence of macroscopic disease after initial debulking surgery, type of prior taxane-based therapy, and route of prior platinum therapy. The investigators hope to recruit 1110 patients.

Sponsor: Gynecologic Oncology Group

ClinicalTrials.gov Identifier: NCT00108745


Docetaxel and gemcitabine with or without bevacizumab for uterine leiomyosarcoma

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Provider and Caregiver Connection™: Addressing Patient Concerns While Managing Chemotherapy Induced Nausea and VomitingOct 31, 20182.0
Clinical Interchange™: Moving Forward From the Status Quo for the Treatment of Soft Tissue Sarcoma: Key Questions and New Answers to Optimize OutcomesOct 31, 20182.0
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