TerminatedPhase 1/2

Trial of Best Supportive Care and Either Cisplatin or Paclitaxel to Treat Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer and Inoperable Malignant Bowel Obstruction

Stopped: Slow accrual

Canada1 participantsStarted 2010-02

Plain-language summary

The best way to treat MBO in patients with ovarian cancer has not been studied enough by trials that assess how more than one treatment arm (surgical, chemotherapeutic, supportive care approaches) affects clinical outcomes like resolution of bowel obstruction, survival, and quality of life. To improve patient outcomes, we must assess which patients will do better with palliative surgery, chemotherapy, or best supportive care. This study will gather safety information, and how reasonable it is to give chemotherapy and BSC to patients with advanced ovarian cancer and MBO who are non-surgical candidates. This study will also look into the effects of chemotherapy and BSC on the quality of life and resolution of bowel obstruction, in hopes to perform future studies that lead to the best management of MBO.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A diagnosis of primary ovarian cancer, primary peritoneal cancer or fallopian tube cancer
✓. At least two of the following four symptoms: (a) vomiting (\>2 episodes in past 24 hours), (b) abdominal pain, (c) not passing gas per rectum in past 24 hours, (d) severe constipation (no bowel movement \>24 hours).
✓. CT findings suggestive of complete bowel obstruction. CT Abdomen: confirms diagnosis of bowel obstruction (93% sensitivity 93-100% specificity) and aids in determining the location and etiology of obstruction.

What they're measuring

Overall Safety Profile

Timeframe: Day 1 of treatment until resolution of symptoms

Quality of Life Scores at Baseline, Day 30 and Day 90

Timeframe: Day 1 of treatment until resolution of symptoms

Time to Resolution of Bowel Obstruction

Timeframe: Day 1 of treatment until resolution of symptoms

Trial details

NCT IDNCT01083537

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-06

View on ClinicalTrials.gov More Ovarian Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A diagnosis of primary ovarian cancer, primary peritoneal cancer or fallopian tube cancer
✓. At least two of the following four symptoms: (a) vomiting (\>2 episodes in past 24 hours), (b) abdominal pain, (c) not passing gas per rectum in past 24 hours, (d) severe constipation (no bowel movement \>24 hours).
✓. CT findings suggestive of complete bowel obstruction. CT Abdomen: confirms diagnosis of bowel obstruction (93% sensitivity 93-100% specificity) and aids in determining the location and etiology of obstruction.