Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing
pelvic radiation therapy.
PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works
in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation
therapy.
OBJECTIVES:
Primary
- To determine whether sulfasalazine is effective in reducing the acute treatment-related
diarrhea in patients receiving pelvic radiotherapy as measured by NCI CTC v4.0 in
patients receiving pelvic external-beam radiotherapy as adjuvant or primary treatment
for malignancy.
Secondary
- To determine whether sulfasalazine can reduce chronic treatment-related bowel
dysfunction following completion of therapy.
- To determine whether sulfasalazine causes any toxicity in this situation.
Tertiary
- To bank blood products for future studies, as part of ongoing research for NCCTG studies
(Mayo Clinic Rochester only). (Translational)
OUTLINE: This is a multicenter study. Patients are stratified according to history of
anterior resection of the rectum (yes vs no); total planned cumulative dosing, including
boost fields of external-beam radiotherapy (4500-5350 cGy vs > 5350 cGy); and concurrent
radiosensitizing fluorouracil, capecitabine, or oxaliplatin (yes vs no). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sulfasalazine twice daily during radiotherapy* and for 4
weeks after completion of radiotherapy.
- Arm II: Patients receive oral placebo twice daily during radiotherapy* and for 4 weeks
after completion of radiotherapy.
NOTE: *Patients must start study treatment by the third radiotherapy fraction.
Patients may undergo blood sample collection at baseline and then weekly during radiotherapy.
All patients complete quality of life and bowel function questionnaires at baseline, weekly
during radiotherapy, and at 6 weeks after completion of radiotherapy.
After completion of radiotherapy, patients are followed up at 6 weeks and at 12 and 24
months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01828775 -
Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
|
N/A | |
| Terminated |
NCT01642342 -
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00002950 -
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01705548 -
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
|
N/A | |
| Completed |
NCT02146222 -
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
|
Phase 1 | |
| Terminated |
NCT01602627 -
Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies
|
Phase 1 | |
| Completed |
NCT01191216 -
1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT00992303 -
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
|
||
| Recruiting |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
| Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
| Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Withdrawn |
NCT00937417 -
S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT00710632 -
Screening to Predict Weight Loss in Patients With Cancer
|
N/A | |
| Completed |
NCT00544596 -
R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer
|
Phase 1 | |
| Completed |
NCT00573690 -
Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT00436735 -
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00352443 -
S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00128622 -
Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT00121277 -
Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 |