High-Priority Clinical Trials

NCI HIGH-PRIORITY PHASE III CLINICAL TRIALS

  The National Cancer Institute has identified a group of high-priority trials that are of particular scientific and clinical interest. The currently active studies are listed below.

VA-CSP-407, NCI-T94-0131O, PIVOT-1, CLB-9492 Phase III Randomized Study of Prostatectomy vs Expectant Observation With Palliative Therapy for Stage I/II Prostate Cancer (PIVOT) (summary last modified: 06/97).

Projected accrual: 2,000 patients over 3 to 4 years. The objectives of this trial are (1) to determine the overall mortality rate in patients with stage I/II prostate cancer treated with radical prostatectomy and early intervention for subsequent disease progression vs expectant management with therapy reserved for palliation of symptomatic or metastatic disease, (2) to determine the prostate cancer-specific survival in these patients, (3) to compare the quality of life in patients receiving these treatments, (4) to determine the progression-free survival in this patient population, and (5) to assess the effects of radical prostatectomy upon disease recurrence. Age range: 75 and under.

Chairperson: Timothy James Wilt. Lead organization: Veterans Administration Cooperative Studies Program Coordinating Center.

SWOG-8710, INT-0080, EST-1887 Phase III Randomized Comparison of Cystectomy Alone vs Neoadjuvant MVAC (MTX/VBL/DOX/CDDP) Plus Cystectomy in Patients With Locally Advanced Transitional Cell Carcinoma of the Bladder (summary last modified: 08/97).

Projected accrual: 298 patients are required. The objectives of this trial are (1) to compare survival of patients with locally advanced bladder cancer randomized to treatment with cystectomy alone vs neoadjuvant chemotherapy with MVAC (methotrexate/vinblastine/ doxorubicin/cisplatin) followed by cystectomy, (2) to quantify the "tumor downstaging" effect of neoadjuvant MVAC, and (3) to explore the feasibility of collecting tissues for genetic/cytogenetic studies, and pilot the detection of nonrandom genetic/cytogenetic changes in these patients. Age range: any age.

Chairperson: Charles A. Coltman,
Jr. Lead organization: Southwest Oncology Group.

E-PBT01, NCI-T90-0180D, PBT-1 Phase III Randomized Comparison of Conventional CMF Maintenance vs High-Dose Combination Chemotherapy Plus Autologous Bone Marrow and Peripheral Stem Cell Rescue in Women With Metastatic Breast Cancer Responding to Conventional Induction Chemotherapy (summary last modified: 06/96).

Projected accrual: 549 patients (at least 99 patients with CR after induction and 247 with PR are required; accrual is expected to take three years for both groups). The objectives of this trial are (1) to compare time to failure and overall survival of patients with metastatic breast cancer responding after 4 to 6 courses of conventional induction chemotherapy who are randomly assigned to 24 months of conventional maintenance chemotherapy with CMF (cyclophosphamide/ methotrexate/fluorouracil) vs high-dose chemotherapy with cyclophosphamide/thiotepa/carboplatin followed by autologous bone marrow and peripheral stem cell rescue, (2) to compare the toxicity of these two regimens, (3) to compare the financial costs of these two regimens, and (4) to evaluate the quality of life associated with these two treatments. Age range: 18 to 60.

Chairperson: Edward Allen Stadtmauer. Lead organization: Eastern Cooperative Oncology Group.

EST-2190, INT-0121, SWOG-9061 Phase III Randomized Study of Adjuvant CAF (Cyclophosphamide/ Doxorubicin/Fluorouracil) vs Adjuvant CAF Followed by Intensification With High-Dose Cyclophosphamide/Thiotepa Plus Autologous Stem Cell Rescue in Women With Stage II/III Breast Cancer at High Risk of Recurrence (summary last modified: 05/97).

Projected accrual: 534 patients over an estimated six years. The objectives of this trial are (1) to compare sites and rates of recurrence, disease-free survival, overall survival, and toxicity of adjuvant chemotherapy with CAF (cyclophosphamide, doxorubicin, fluorouracil) vs adjuvant CAF followed by marrow ablation with cyclophosphamide/thiotepa and autologous stem cell rescue in women with stage II/III breast cancer and 10 or more positive lymph nodes, (2) to evaluate prospectively the incidence and degree of occult marrow contamination with breast cancer cells at the time of study entry and following CAF chemotherapy by analyzing samples of marrow using a panel of monoclonal antibodies specific for breast cancer, (3) to document the changes in psychosocial function that occur during treatment on either regimen, and compare post- treatment recovery of psychosocial function, and (4) to establish a bank of paraffin-embedded tumor samples for future laboratory study. Age range: 15 to 60.

Chairperson: Martin Stuart Tallman. Lead organization: Eastern Cooperative Oncology Group.

CLB-9082, INT-0163, SWOG-9114 Phase III Randomized Comparison of High-Dose Chemotherapy With Autologous Marrow and Peripheral Stem Cell Support vs Standard-Dose Chemotherapy Following Adjuvant Chemotherapy in Women With Stage II/IIIA Breast Cancer With at Least 10 Positive Axillary Nodes (summary last modified: 09/96).

Projected accrual: 800 patients over 6.5 to 7 years. Objectives of this trial are (1) to compare disease-free and overall survival of women with stage II/IIIA breast cancer randomized to receive high-dose cyclophosphamide/cisplatin/carmustine with autologous bone marrow/peripheral stem cell support plus chest wall irradiation vs conventional doses of the same drugs plus chest wall irradiation, administered after 4 courses of adjuvant cyclophosphamide/doxorubicin/fluorouracil (CAF), and (2) to compare the toxic effects of these two regimens. Age range: over 18.

Chairperson: William P. Peters. Lead organization: Cancer and Leukemia Group B.

SWOG-9321, INT-0141, CLB-9312 Phase III Randomized Study of L-PAM/TBI With PBSC Rescue vs VBMCP (VCR/BCNU/L-PAM/CTX/ PRED) Following Standard Induction for Previously Untreated Symptomatic Multiple Myeloma, With Further Randomization for Major Responders to IFN-A vs Observation (summary last modified: 12/97).

Projected accrual: 500 patients randomized over about four years to autologous transplantation vs chemotherapy. The objectives of this trial are (1) to compare tumor cytoreduction achieved with VBMCP (vincristine/carmustine/melphalan/cyclophosphamide/prednisone) vs myeloablative melphalan (L-PAM) and total-body irradiation (TBI) with peripheral blood stem cell (PBSC) rescue in symptomatic myeloma patients with stable or responding disease following induction therapy with VAD (vincristine/doxorubicin/dexamethasone) followed by high-dose cyclophosphamide plus granulocyte colony-stimulating factor, (2) to compare the efficacy of interferon-alfa vs no maintenance therapy in those achieving at least 75% cytoreduction to either VBMCP or myeloablative therapy with PBSC rescue, (3) to assess allogeneic bone marrow transplantation following the same myeloablative regimen of L-PAM/TBI in patients up to age 55 with an HLA-compatible, MLC-nonreactive donor (as of 8/1/ 97, permanent partial closure), (4) to determine whether myeloablative therapy with PBSC rescue can extend the duration of survival by 33% compared to results from standard-dose VBMCP, and (5) to evaluate the toxic effects and possible long-term side effects, including development of myelodysplastic disease and/or acute myeloblastic leukemia, associated with these treatments. Age range: no older than 70.

Chairperson: Bart Barlogie. Lead organization: Southwest Oncology Group.

NSABP-B-21, NCOG-NSABP-B-21 Phase III Trial of Adjuvant Therapy With Tamoxifen vs Placebo, Plus Radiotherapy, in the Management of Patients With Clinically Occult, Invasive, Node-Negative Breast Cancer Treated by Lumpectomy (summary last modified: 12/97).

Projected accrual: 1,690 patients (as of 1/96, 963 patients remain to be entered over approximately 3 years). The objectives of this trial are (1) to determine, in a randomized phase III setting, the effectiveness of long-term treatment with tamoxifen, with and without breast irradiation, in prolonging disease-free survival in patients with clinically occult, invasive, node-negative breast cancer, (2) to determine the natural history of patients with clinically occult invasive cancer treated by lumpectomy and breast irradiation, (3) to estimate and compare the rate of ipsilateral breast tumor recurrence following lumpectomy in patients with clinically occult invasive cancer who receive adjuvant therapy with breast irradiation plus placebo vs breast irradiation plus tamoxifen vs tamoxifen alone, and (4) to monitor the effect of tamoxifen on the incidence of second primary cancers of the opposite breast in this population. Age range: 18 to 75.

Chairperson: Terry Mamounas. Lead organization: National Surgical Adjuvant Breast and Bowel Project.

NCCTG-934653, INT-0146, SWOG-9411 Phase III Randomized Study of Laparoscopic-Assisted Colectomy vs Open Colectomy for Colon Cancer (summary last modified: 11/96).

Projected accrual: 1,200 patients over 3 years. The objectives of this trial are (1) to compare the disease-free and overall survival rates of patients with colon cancer randomized to laparoscopic-assisted colectomy vs open colectomy, (2) to assess the frequency of treatment-related early and late morbidity and 30-day mortality of patients on both arms, and (3) to compare the differences in quality of life, costs, and cost effectiveness between the 2 arms. Age range: at least 18.

Chairperson: Heidi Nelson. Lead organization: North Central Cancer Treatment Group.

RTOG-9309, INT-0139, SWOG-9336 Phase III Randomized Study of Concurrent Radiotherapy and CDDP/VP-16 With vs Without Surgical Resection for Stage IIIA (N2) non-Small Cell Lung Cancer (summary last modified: 07/97).

Projected accrual: 510 patients will be entered over 4 to 5 years to provide 484 evaluable patients. The objectives of this trial are (1) to assess whether concurrent radiotherapy and cisplatin/etoposide followed by surgical resection results in a significant improvement in progression-free survival, median survival, and 2- and 5-year survivals compared to standard chemoradiotherapy for stage IIIA (N2) non-small cell lung cancer, (2) to evaluate patterns of local and distant failure on these two regimens, and (3) to explore the relationship of tobacco use, alcohol use, and diet with toxicity and outcome in both men and women. Age range: 18 and over.

Chairperson: David S. Ettinger. Lead organization: Radiation Therapy Oncology Group.

RTOG-9111, EST-R9111 Phase III Randomized Trial of Laryngeal Preservation With CDDP/5-FU Followed by Radiotherapy vs Concomitant Radiotherapy and CDDP vs Radiotherapy Alone in Patients With Stage III/IV Squamous Cell Cancer of the Glottic and Supraglottic Larynx (summary last modified: 09/96).

Projected accrual: 546 patients entered over approximately 3 years. The objectives of this trial are (1) to compare, in a phase III setting, overall and disease-free survival with preservation of laryngeal function in patients with stage III/IV squamous cell carcinoma of the glottic and supraglottic larynx treated with cisplatin/fluorouracil (CDDP/5-FU) followed by radiotherapy vs concomitant radiotherapy plus CDDP vs radiotherapy alone, (2) to compare the tumor response after completion of chemotherapy but prior to initiation of radiotherapy with that following completion of radiotherapy and concurrent chemotherapy, (3) to compare the patterns of relapse (local and regional recurrence and distant metastasis) with these treatments, (4) to compare the incidence of second primary tumors in patients treated on these three regimens, (5) to compare the acute and chronic adverse effects of these three regimens, (6) to compare the morbidity experienced with neck dissection and/or laryngeal salvage surgery following treatment with these regimens, (7) to compare quality of life of patients with laryngeal preservation vs patients requiring salvage laryngectomies, and (8) to compare the quality of life of patients receiving radiotherapy alone vs those receiving chemotherapy as well. Age range: 18 and over.

Chairperson: Helmuth Goepfert. Lead organization: Radiation Therapy Oncology Group.

SWOG-9008, INT-0116, RTOG-9018 Phase III Randomized Study of Adjuvant Chemoradiotherapy With 5-FU/CF in Patients With Resected Gastric Cancer (summary last modified: 04/97).

Projected accrual: 550 patients randomized over an anticipated 66 months. The objectives of this trial are (1) to compare disease-free and overall survival in patients randomized to adjuvant chemotherapy with fluorouracil/leucovorin administered with radiotherapy vs no adjuvant therapy in patients with resected gastric cancer, (2) to compare the incidence and patterns of disease failure on these two arms, and (3) to assess patient tolerance to upper abdominal chemoradiation after gastric resection. Age range: any age.

Chairperson: John Steven Macdonald. Lead organization: Southwest Oncology Group.

Legend for abbreviations:

CLB = Cancer & Leukemia Group B

E, EST = Eastern Cooperative Oncology Group

INT = Intergroup Study

NCCTG = North Central Cancer Treatment Group

NCOG = Northern California Oncology Group

NSABP = National Surgical Adjuvant Project for Breast & Bowel Cancers

PBT = Philadelphia Bone Marrow Transplant Group

RTOG = Radiation Therapy Oncology Group

SWOG = Southwest Oncology Group

VA-CSP = VA Cooperative Studies Program

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