Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00331760|
Recruitment Status : Completed
First Posted : May 31, 2006
Results First Posted : June 3, 2013
Last Update Posted : February 17, 2017
RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Endometrial Cancer||Drug: cisplatin Radiation: intensity-modulated radiation therapy||Phase 2|
- Determine the transportability of intensity modulated radiotherapy (IMRT) to a multi-institutional setting in patients with resected endometrial or cervical cancer.
- Compare the efficacy, in terms of reducing short-term bowel injury, of IMRT versus standard treatments.
- Assess adverse events related to this regimen.
- Estimate the rates of local-regional control, distant metastasis, and disease-free and overall survival.
- Evaluate chemotherapy compliance with this regimen for patients with cervical carcinoma.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (cervical vs endometrial cancer).
All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for 5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day 1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 weeks post-IMRT and then every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3 years.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||December 2016|
Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.
Radiation: intensity-modulated radiation therapy
Cervical Cancer: IMRT + Chemotherapy (cisplatin)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks and concurrent weekly cisplatin 40 mg/m^2 for five weeks.
Radiation: intensity-modulated radiation therapy
- Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review) [ Time Frame: IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery. ]
Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%.
For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%.
- Grade 2+ Bowel Adverse Events (Diarrhea, Enteritis, Fistula, Ileus; Gastrointestinal (GI), Incontinence; Anal, Necrosis; GI, Obstruction; GI, Perforation; GI, Proctitis and Stricture/Stenosis (Including Anastomotic) as Graded by CTCAE v. 3.0) [ Time Frame: From the start of treatment to 90 days. ]
- All Other Adverse Events [ Time Frame: From start of treatment to the end of follow-up. ]
- Chemotherapy Compliance for Cervical Carcinoma Patients [ Time Frame: Chemotherapy treatment is centrally reviewed for quality assurance and compliance. ]
- Local-regional Failure [ Time Frame: From registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ]
- Distant Metastases [ Time Frame: From registration to date of distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ]
- Disease-free Survival [ Time Frame: From registration to date of failure (any tumor recurrence, development of distant metastases or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ]
- Overall Survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331760
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|Study Chair:||Anuja Jhingran, MD||M.D. Anderson Cancer Center|