Maurice Staquet

Cancer clinical trials : methods and practice

The first complete guide to organizing and running cancer clinical trials, this book brings together in a single volume information on the fundamental concepts of trials, design, planning, conduct, and analysis that has previously ben scattered throughout medical and statistical literature. Topics covered include scientific background, ethical considerations, design and quality control, treatment toxicities and results in solid and non-solid tumors, preclinical and phase I trials, design of phase II trials, and analysis of phase III trials. The editors have updated the original 1984 text for this new paperback edition.

Methodology for the assessment of new dichotomous diagnostic tests

Abstract The correct evaluation of a new diagnostic test requires the knowledge of the true status of the patient. Practically, such a favorable situation is rarely encountered and the status is most usually determined through one or several imperfect reference tests. In this case, a bias is introduced in assessing new diagnostic procedures and prevalence becomes a variable of prominent importance when calculating predictive values as well as sensitivity and specificity. Prevalence also affects the statistical parameters of the new tests in two-stage designs, and corrective procedures are necessary in these instances. This paper focuses an adjustment to be made to allow a correct assessment of new diagnostic procedures in specific situations.

Guidelines for reporting results of quality of life assessments in clinical trials

Clinical trials involving quality of life measurement published in the literature suffer from important weaknesses due to the lack of information on numerous topics. The psychometric properties of the instruments are often lacking as well as data on the number of patients treated and analyzed. The handling of missing data is rarely documented. In order to facilitate the reporting of trials and the evaluation of published results, this article proposes a set of general guidelines for the reporting of clinical trials which include a quality of life assessment. A checklist designed to assist authors is appended.

Effect of a nitrogen analog of tetrahydrocannabinol on cancer pain

Two consecutive, randomized, double‐blind trials were performed to test the analgesic properties of a synthetic nitrogen analog of tetrahydrocannabinol (NIB). In the first trial, the test preparation was superior to placebo and approximately equivalent to 50 mg of codeine phosphate. In the second study, the tetrahydrocannabinol analog was superior to placebo and to 50 mg secobarbital. NIB is not useful clinically because of the frequency of side effects.

A double-blind study with placebo control of intramuscular ketorolac tromethamine in the treatment of cancer pain

The analgesic efficacy of ketorolac tromethamine was compared to placebo in 126 patients suffering moderate or severe chronic pain due to cancer in a double‐blind parallel randomized study. Ketorolac was administered intramuscularly in doses of 10, 30 or 90 mg. Pain intensity and pain relief were assessed for 6 hours by scoring standard verbal scales and an overall assessment of the medication was given by the patients and the observer on completion of the study. Each dose of ketorolac was statistically superior to placebo for the sum of pain intensity difference (SPID) but no difference was seen between the three ketorolac regimens. When the ketorolac groups are combined, there was a significantly better pain relief as compared to placebo. The global evaluation scores were also statistically superior in the ketorolac groups combined than in the placebo group. A total of 15 patients reported minor adverse events, 10 being after ketorolac doses. This study shows that single intramuscular doses of ketorolac of 10 mg and above are effective in the relief of cancer pain, and are associated with a low incidence of side‐effects.

Antibacterial activity and pharmacokinetics of bacampicillin and ampicillin

Single equimolar oral doses of bacampicillin and ampicillin were given to 9 healthy subjects on a crossover randomized basis. Data were interpreted in terms of a 3‐compartment pharmacokinetic open model. Intestinal absorption of bacampicillin was found to be faster and more complete than that of ampicillin, yielding an increase in bioavailability of 30% to 40% as measured by the area under serum levels curve, the urinary excretion and absorption rate constants. After the administration of bacampicillin, much higher and sharper peaks were achieved in the serum and in the “tissue” water than after the administration of ampicillin. The maximum bactericidal dilution (MBD) of the serum samples taken 1 hr after the administration of the antibiotics against 10 strains of Diplococcus pneumoniae was higher following bacampicillin (p < 0.01), as was the MBD of the 0 to 2 hr urine specimens against 10 strains of Escherichia coli. Further clinical trials are required to accurately assess the possible greater therapeutic effectiveness of bacampicillin than of ampicillin.

Analgesic effect of ciramadol in patients with chronic pain

A double-blind, crossover study was carried out in 15 patients with chronic pain due to cancer to assess the effectiveness of two different doses of a new analgesic, ciramadol, compared with placebo. Patients received single oral doses of the three medications, in random order, on successive days. Assessments of pain intensity and relief were made on a 4-point rating scale at hourly intervals for 4 hours after the dose. The results showed that ciramadol produced significantly more pain relief than did placebo and this analgesic effect increased with the dose administered. Peak activity was observed at about 2 hours, and pain relief was still marked at 4 hours. No side-effects were reported.

Clinical Studies with a THC Analog (BRL‐4664) in the Prevention of Cisplatin‐Induced Vomiting

Abstract: BRL‐4664, a THC analog, has been administered to 23 patients at a dose of 10 or 15 mg repeated twice. All patients were on cisplatin therapy, and 16 of them had experienced severe vomiting during the previous course of cisplatin. There was a statistically significant difference between the group with prior cisplatin therapy and without prior therapy in terms of number of vomiting episodes, emphasizing the role of conditioned reflexes. The dose of 15 mg administered before and twice after the infusion of cisplatin was well tolerated. Only minor side effects were observed.

Adjuvant Therapy of T1 Bladder Carcinoma: Preliminary Results of an EORTC Randomized Study

This paper reports the preliminary results of an ongoing clinical trial in patients with category T1 bladder cancer who are randomized after transurethral resection to receive either thiotepa, VM-26, or no treatment. While there are no significant differences between the three treatment groups with respect to the time until first recurrence, thiotepa has significantly reduced the recurrence rate as compared to either VM-26 (P = 0.03) or no treatment (P = 0.04) among the 215 patients for whom follow-up information is currently available.

EORTC randomized trial for the adjuvant therapy of T1 bladder carcinoma.

A randomized clinical trial was designed by the European Organization for Research on Treatment of Cancer (EORTC) to compare the disease-free interval, the degree of malignancy of recurrence and the 5-year survival rate in stage I papillary carcinoma of the bladder after TUR only, and after TUR followed either by local thiotepa or by local VM 26 chemotherapy.